This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for An Efficacy and Safety Study of Sevelamer Carbonate in Hyperphosphatemic Pediatric Participants With Chronic Kidney Disease (NCT01574326), a randomized phase 2 study. The primary outcome is Change From Baseline (Week 0) to Week 2 in Serum Phosphorus.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01574326 |
| Phase | Phase 2 |
| Condition | Hyperphosphatemia, Chronic Kidney Disease |
| Allocation | Randomized |
| Design model | Single Group |
| Masking | Double |
| Enrollment | 101 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Genzyme, a Sanofi Company |
| Results posted | Yes |
2. Clinical Question
Population
Pediatric participants with chronic kidney disease and hyperphosphatemia. The registry record lists 101 participants enrolled. The primary analysis population was narrower: treated participants with a baseline phosphorus value and at least one post-baseline assessment after the first dose and on or before Week 2.
Intervention
Sevelamer carbonate during the two-week fixed dose period, followed by sevelamer carbonate during the 26-week dose-titration period. The primary comparison concerns the fixed dose period, not the longer follow-up.
Comparator
Placebo during the two-week fixed dose period. Participants assigned to placebo then received sevelamer carbonate during the 26-week dose-titration period, according to the arm description.
Primary question
What was the mean change in serum phosphorus from baseline to Week 2 in the fixed dose period, comparing participants randomized to sevelamer carbonate with those randomized to placebo? The numerical endpoint results are not reported in the registry record.
The clinical question is framed around control of serum phosphorus in pediatric participants with chronic kidney disease and hyperphosphatemia. The registry states that the study objectives included evaluating both the safety and tolerability of sevelamer carbonate and its efficacy on serum phosphorus control. The primary endpoint operationalizes the efficacy question as a change from baseline over the randomized, placebo-controlled period.
The follow-on period addresses a different question. Participants received sevelamer carbonate during dose titration for 26 weeks, including those who had received placebo during the fixed dose period. The listed secondary outcome is change from baseline to Week 28 or early termination. Because the later period is described as single-arm and open-label, it does not provide the same randomized placebo comparison as the primary endpoint.
The record does not report the primary endpoint values, an estimated between-group contrast, or a confidence interval. It is therefore not possible to describe the direction, magnitude, or precision of the randomized comparison from the registry information recorded.
3. Trial Design
This is a Phase 2 study with randomized allocation and double masking recorded in the trial descriptors. The official title describes a two-week randomized, placebo-controlled fixed dose period followed by a six-month, single-arm, open-label dose-titration period. The arm descriptions specify 26 weeks for the dose-titration period. The study status is completed, and the recorded enrollment is 101.
During the fixed dose period, one group received placebo and another received sevelamer carbonate. The arm descriptions then indicate that both groups received sevelamer carbonate for an additional 26 weeks during dose titration. This structure creates two distinct interpretive periods: a randomized placebo comparison over two weeks and a longer follow-on period without a placebo group described in the record. The later results therefore should not be treated as though they came from a continuing randomized comparison.
There is an apparent difference between the registry’s general design descriptors and its study description: the model is listed as single group, while allocation is listed as randomized and the treatment arms describe a randomized two-group fixed dose period. The official title and arm descriptions make the staged structure clear, but the reason for the single-group model label is not reported in the registry record.
The primary endpoint is change from baseline at Week 2 in serum phosphorus, measured in mg/dL. It is described as a mean with standard deviation, and the analysis population is the full analysis set for the fixed dose period. The secondary outcome listed is change from baseline to Week 28 or early termination. The record lists three outcome measures and one analysis, but does not provide the complete set of outcome details or a statistical analysis plan.
The record gives a start date of 2012-05 and primary completion date of 2015-06. It does not report further details about recruitment, the randomization procedure, allocation concealment, or how masking was maintained.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: Participants were stratified in (1:1) by screening body surface area (BSA) (≥1.2 vs \<1.2 m\^2) \& qualifying serum phosphorus (≥7.0 vs \<7.0 mg/dL) to get sevelamer carbonate or placebo in 2 week fixed dose period (FDP). Following FDP, participants entered 26-week dose titration period (DTP) during which all participants received sevelamer carbonate.
Overall Study
| Stage | FDP-Placebo for Sevelamer Carbonate, DTP-Sevelamer Carbonate | FDP-Sevelamer Carbonate, DTP-Sevelamer Carbonate |
|---|---|---|
| STARTED | 51 | 50 |
| Treated | 51 | 49 |
| COMPLETED | 35 | 31 |
| NOT COMPLETED | 16 | 19 |
Reasons for not completing this period:
| Reason | FDP-Placebo for Sevelamer Carbonate, DTP-Sevelamer Carbonate | FDP-Sevelamer Carbonate, DTP-Sevelamer Carbonate |
|---|---|---|
| Randomized but not treated | 0 | 1 |
| Withdrawal by Participant | 2 | 4 |
| Physician Decision | 5 | 3 |
| Adverse Event | 1 | 3 |
| Other: Mainly kidney transplant | 8 | 8 |
Analysis population for the primary outcome, as defined in the registry: FAS-FDP population included all treated participants with a baseline phosphorus value and at least 1 post-baseline assessment after the first dose of study drug and on or before Week 2. Three participants (1 in sevelamer carbonate group and 2 in placebo group) were excluded from FAS-FDP due to no baseline phosphorus value at week 2.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | FDP-Placebo for Sevelamer Carbonate, DTP-Sevelamer Carbonate | FDP-Sevelamer Carbonate, DTP-Sevelamer Carbonate | Total |
|---|---|---|---|---|
| Participants analysed | 51 | 50 | 101 | |
| Age, Continuous | years | 14.3 (SD 3.11) | 13.9 (SD 2.75) | 14.1 (SD 2.93) |
| Sex: Female, Male: Female | Participants | 18 | 19 | 37 |
| Sex: Female, Male: Male | Participants | 33 | 31 | 64 |
6. Primary Endpoint
The registry lists the primary outcome as Change From Baseline (Week 0) to Week 2 in Serum Phosphorus, measured over Baseline, Week 2.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | mg/dL |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is change in serum phosphorus from baseline, defined as Week 0, to Week 2. It is a continuous measure recorded in mg/dL and summarized as a mean with standard deviation. The endpoint is tied directly to the stated efficacy objective of evaluating sevelamer carbonate for control of serum phosphorus in pediatric participants with chronic kidney disease and hyperphosphatemia.
Using change from baseline focuses the comparison on how the measured value shifts over the randomized fixed dose period, rather than on the Week 2 measurement alone. The baseline value provides the starting point for each participant’s change. In a randomized comparison, the relevant efficacy question is whether the distribution of these changes differs between the sevelamer carbonate and placebo groups. The registry record does not report the group means, the between-group estimate, or uncertainty around that estimate, so the endpoint’s observed direction and magnitude cannot be described.
The primary analysis population is the fixed dose period full analysis set. The record defines it as treated participants with a baseline phosphorus value and at least one post-baseline assessment after the first dose and on or before Week 2. Three participants were excluded from this set, one in the sevelamer carbonate group and two in the placebo group. The registry’s population description says the exclusions were due to “no ba” before its text ends; the complete reason is not reported in the registry record.
The listed secondary measure extends the change-from-baseline assessment to Week 28 or early termination. That later measure covers the dose-titration period as well as the initial treatment period and should be interpreted separately from the two-week primary endpoint.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The primary endpoint is clinically aligned with the trial’s stated efficacy objective, but the registry record does not give its numerical results. No group-specific mean changes, standard deviations, between-group estimate, confidence interval, or p-value are reported in the available outcome information. Consequently, the posted record does not support a description of how large the randomized difference was, which group had the greater mean change, or how precisely that difference was estimated.
The treatment comparison must also be kept within its time frame. The fixed dose period is the randomized, placebo-controlled part of the study and lasts two weeks. The subsequent dose-titration period is described as open-label and single-arm, with participants receiving sevelamer carbonate. Results from that later period cannot be read as a controlled estimate of the difference between sevelamer carbonate and placebo, because the arm descriptions do not identify a continuing placebo group.
The record lists a secondary outcome extending to Week 28 or early termination, but does not report its result. Nor does it provide the details needed to assess the statistical uncertainty or completeness of that longer-term measure. The fact that an outcome is listed is not evidence of a particular result.
For safety, the record lists counts of participants affected by serious adverse events and other adverse events in the fixed dose and dose-titration groups. These figures describe reported events in their stated groups; they do not by themselves establish that an event was caused by treatment. The dose-titration group represents a different, longer treatment period from the fixed dose groups, so its counts should not be interpreted as a direct randomized comparison. Death counts are not reported in the registry record.
Some serious adverse event terms are listed with percentages, including hypertension at 4.1%, abdominal pain at 3.0%, and pyrexia at 3.0%. The record does not identify the denominator or treatment period for these term percentages in the information available, so they should not be assigned to a particular group or treated as comparative rates.
Overall, the registry record establishes the study question, design stages, endpoint definition, analysis population criteria, and selected safety counts. It does not provide the primary efficacy estimates needed to judge the observed randomized comparison. Any interpretation of efficacy beyond the design and outcome definitions would require results not reported in the registry record.
9. Statistical Methods Explained
The primary measure is continuous: it records change in serum phosphorus in mg/dL. A mean describes the average change in the analysis population, while a standard deviation describes how spread out individual changes are around that average. The standard deviation is not itself a measure of the precision of the estimated mean. Precision is usually assessed with a standard error or confidence interval, but those results are not reported in the registry record.
General: a confidence interval expresses the range of estimates compatible with the data under the analysis assumptions. A narrower interval indicates greater precision than a wider interval, while the interval’s location conveys the direction and plausible magnitude of the estimated effect. Without a reported estimate and interval, the size and precision of this trial’s primary comparison cannot be assessed from the registry record.
The endpoint is change from baseline to Week 2. General: analyzing change can account for each participant’s starting measurement by expressing the endpoint as a within-participant difference between the later and baseline values. A randomized comparison then contrasts the groups’ changes. The registry description says the change was calculated, but does not report the group-level values or the method used to estimate the between-group contrast.
The analysis population is described as the full analysis set for the fixed dose period. It includes treated participants with a baseline value and at least one post-baseline assessment after the first dose and on or before Week 2. Participants were analyzed according to randomized treatment, as stated in the endpoint description. The record says three participants were excluded from this population, but its explanation of why ends after “no ba”; the complete reason is not reported in the registry record.
What does randomization contribute?
General: random assignment is intended to make treatment groups comparable, on average, at the start of a study. It supports a causal interpretation of a between-group contrast when the analysis preserves the randomized comparison and other design and analysis assumptions are reasonable. Randomization does not guarantee that every measured or unmeasured characteristic will be identical between groups, especially in a finite study. The registry record lists randomized allocation, but does not report the randomization sequence method, stratification factors, or allocation concealment procedures.
What does masking mean for this comparison?
The trial descriptor records double masking for the randomized study. General: masking is intended to limit how knowledge of treatment assignment may influence participant experiences, care, outcome assessment, or reporting. The registry record does not describe who was masked or how masking was implemented. The later dose-titration period is explicitly described as open-label, so the masking descriptor for the study should not be applied automatically to that later stage.
How should the two study periods be separated?
The fixed dose period provides the placebo-controlled comparison over two weeks. The later dose-titration period is described as single-arm and open-label, and the arm descriptions say participants in both initial groups received sevelamer carbonate for an additional 26 weeks. General: a before-and-after change during an uncontrolled period can reflect treatment exposure, but can also reflect time trends, other changes in care, measurement variation, or selective availability of follow-up data. Without a concurrent comparison group, those influences cannot be separated in the same way as in a randomized contrast.
The study description calls the later period six months, while the arm descriptions specify 26 weeks. Both descriptions identify the period as the follow-on dose-titration stage. The record does not state how dose titration was determined or what dose levels were used.
What statistical details are unavailable?
The primary outcome is described as a mean with standard deviation, but the registry record does not report the numerical summary statistics, a treatment-effect estimate, confidence interval, hypothesis test, or p-value. It does not report the statistical model, covariate adjustment, handling of repeated measurements, or assumptions used for the primary analysis. The statistical analysis plan is not reported in the registry record.
General: continuous measurements may be analyzed using methods that compare group means, but the appropriateness of a particular method depends on the trial design, distribution of the data, missingness, and analysis objectives. No specific method should be attributed to this trial when it is not described in the record.
General: over-dispersion is relevant when observed variability exceeds what a chosen probability model expects. A model that accounts for that extra variability may produce more realistic uncertainty estimates. This is a general statistical consideration, not a feature reported for this continuous endpoint or for this trial.
The sample-size assumptions recorded for planning illustrations describe a two-sided significance level of 0.05, equal allocation, a normal approximation, and effects set as fractions of the observed effect. These are explicitly planning assumptions based on an observed effect, not a reported design justification or the trial’s own planned sample-size calculation. No sample-size justification is reported in the registry record, and a planning illustration is not observed power.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists three outcome measures and one analysis. The primary endpoint is change in serum phosphorus from baseline to Week 2; the listed secondary outcome is change from baseline to Week 28 or early termination. The complete details for all outcome measures are not reported in the registry record, so the number of distinct hypotheses or comparisons intended for formal testing cannot be established from these registry entries alone.
Multiplicity arises when several outcomes, time points, groups, or analyses are tested. General: conducting multiple tests can increase the chance of obtaining at least one apparently notable result by chance. Study plans may address this through a prespecified testing sequence or adjustment, but no multiplicity strategy is reported in the registry record. The record also does not report whether the primary endpoint was tested using a prespecified statistical analysis plan.
The primary population definition requires treatment, a baseline value, and at least one post-baseline assessment in the specified period. Three participants were excluded from the fixed dose full analysis set: one assigned to sevelamer carbonate and two assigned to placebo. The population description is cut off after “no ba,” so the full stated explanation for these exclusions is not reported in the registry record.
Information about missing outcome values, withdrawal, imputation, sensitivity analyses, or reasons for missing assessments is not reported in the registry record. General: missing data can affect both the analysis population and the conclusions if availability of measurements is related to treatment, outcome, or participant characteristics. The direction and size of any such effect cannot be determined without details about missingness and the methods used to address it.
The registry record does not report interim analyses, stopping rules, or a sample-size justification. These should not be inferred from the trial’s enrollment or its planning assumptions.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| FDP - Placebo | 1 | 51 | 2.0% |
| FDP - Sevelamer Carbonate | 4 | 49 | 8.2% |
| DTP - Sevelamer Carbonate | 31 | 100 | 31.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| FDP - Placebo | 6 of 51 |
| FDP - Sevelamer Carbonate | 7 of 49 |
| DTP - Sevelamer Carbonate | 57 of 100 |
Most frequent serious adverse event terms
| Event term | Organ system | FDP - Placebo | FDP - Sevelamer Carbonate | DTP - Sevelamer Carbonate |
|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | 0 of 51 | 0 of 49 | 3 of 100 |
| Pyrexia | General disorders | 0 of 51 | 0 of 49 | 3 of 100 |
| Peritonitis | Infections and infestations | 0 of 51 | 1 of 49 | 2 of 100 |
| Hyperkalaemia | Metabolism and nutrition disorders | 0 of 51 | 1 of 49 | 2 of 100 |
| Hypertension | Vascular disorders | 0 of 51 | 2 of 49 | 1 of 100 |
| Anaemia | Blood and lymphatic system disorders | 0 of 51 | 0 of 49 | 2 of 100 |
| Constipation | Gastrointestinal disorders | 0 of 51 | 0 of 49 | 2 of 100 |
| Device malfunction | General disorders | 0 of 51 | 0 of 49 | 2 of 100 |
| Device occlusion | General disorders | 0 of 51 | 1 of 49 | 1 of 100 |
| Bacteraemia | Infections and infestations | 0 of 51 | 0 of 49 | 2 of 100 |
Most frequent non-serious adverse event terms
| Event term | Organ system | FDP - Placebo | FDP - Sevelamer Carbonate | DTP - Sevelamer Carbonate |
|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | 3 of 51 | 0 of 49 | 19 of 100 |
| Headache | Nervous system disorders | 2 of 51 | 2 of 49 | 17 of 100 |
| Nausea | Gastrointestinal disorders | 2 of 51 | 0 of 49 | 15 of 100 |
| Pyrexia | General disorders | 0 of 51 | 1 of 49 | 16 of 100 |
| Abdominal pain | Gastrointestinal disorders | 0 of 51 | 1 of 49 | 13 of 100 |
| Abdominal pain upper | Gastrointestinal disorders | 2 of 51 | 0 of 49 | 9 of 100 |
| Upper respiratory tract infection | Infections and infestations | 0 of 51 | 0 of 49 | 10 of 100 |
| Diarrhoea | Gastrointestinal disorders | 0 of 51 | 1 of 49 | 8 of 100 |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 0 of 51 | 1 of 49 | 8 of 100 |
| Hypotension | Vascular disorders | 1 of 51 | 0 of 49 | 8 of 100 |
Serious events with the highest arm-level rate: hypertension (4.1%), abdominal pain (3.0%), pyrexia (3.0%), device occlusion (2.0%), peritonitis (2.0%).
The fixed dose safety groups list 1 participant with a serious adverse event among 51 at risk in the placebo group and 4 among 49 at risk in the sevelamer carbonate group. For other adverse events, the corresponding counts are 6 among 51 and 7 among 49. The dose-titration group lists 31 participants with a serious adverse event among 100 at risk and 57 with other adverse events among 100 at risk.
These figures refer to different study periods. The first two groups are from the two-week fixed dose period; the dose-titration group covers the later 26-week period, when participants received sevelamer carbonate. The treatment periods and group structures differ, so the counts should not be read as a randomized comparison across all three groups. The registry record does not provide exposure-adjusted rates or additional detail about event timing.
The record lists hypertension at 4.1%, abdominal pain at 3.0%, and pyrexia at 3.0% among the top serious adverse event terms, alongside device occlusion at 2.0%, peritonitis at 2.0%, and hyperkalaemia at 2.0%. The denominator and group assignment for these percentages are not reported in the registry record. Death counts are also not reported in the registry record.
Adverse event counts describe reported events or affected participants as categorized in the record; they do not establish that treatment caused an event. The figures should be read as safety observations, not as proof of a treatment effect on safety.
12. What the Result Does, and Does Not, Mean
The registry record describes a study designed to evaluate the safety, tolerability, and serum phosphorus efficacy of sevelamer carbonate in pediatric participants with chronic kidney disease and hyperphosphatemia. Its primary endpoint is a mean change in serum phosphorus from baseline to Week 2, during a randomized placebo-controlled fixed dose period. Those design details identify the intended comparison and outcome.
However, the primary numerical result is not reported in the registry record. There is no reported group mean change, treatment contrast, confidence interval, or p-value. The direction, magnitude, and precision of the primary comparison therefore cannot be stated. The record’s absence of these results should not be interpreted as evidence that there was no effect or that there was an effect.
The longer dose-titration period has a different interpretation. It is described as open-label and single-arm, with participants receiving sevelamer carbonate. A change over that period may be informative as a descriptive follow-up measure, but without a concurrent placebo group it is not the same kind of evidence as the randomized two-week comparison. The Week 28 or early-termination secondary outcome is listed, but its numerical result is not reported in the registry record.
The safety entries give counts of participants affected in the stated periods and list selected serious adverse event terms. They do not establish whether an event was caused by study treatment, and the different lengths and structures of the periods limit direct comparison. The term percentages are not accompanied by a denominator or group attribution in the record information available. Death counts are not reported in the registry record.
General: statistical interpretation depends not only on whether an estimate is available, but also on its uncertainty, the analysis population, missing data, and the design of the comparison. Those elements cannot be fully evaluated from the registry entries recorded for this study. The design and endpoint definitions can be described; a conclusion about the observed efficacy result cannot be drawn from the posted registry information.
13. Why This Trial Matters Statistically
This trial is statistically notable for separating a short randomized comparison from a longer open-label dose-titration period. Keeping those stages distinct is essential: the first is designed to compare sevelamer carbonate with placebo over two weeks, while the later stage is described as single-arm and does not preserve the same placebo comparison. Treating both periods as one continuous controlled experiment would misrepresent the design.
The primary endpoint is a continuous change measure, expressed as a mean and standard deviation. This makes clear what type of summary was intended, but it is not enough to evaluate the result. An estimate of the between-group difference and a measure of uncertainty are needed to understand both the direction and precision of the comparison. Those numerical results are not reported in the registry record.
The population definition also matters. The fixed dose analysis set requires participants to have received treatment, a baseline phosphorus value, and at least one post-baseline assessment. The record notes three exclusions and gives randomized-treatment analysis language, but its explanation of the exclusions is incomplete. Information about missing outcome data and its handling is not reported.
Safety interpretation likewise depends on context. Counts from the two-week fixed dose groups and the longer dose-titration group describe different periods and cannot be treated as directly comparable randomized rates. The record’s event-term percentages lack a stated denominator and group attribution in the available details.
Together, these features show why registry design labels, endpoint definitions, analysis populations, and numerical results must be considered separately. The record provides useful information about the intended question and study structure, but the missing efficacy estimates and analysis details limit statistical interpretation of the findings.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The principal limitation for interpreting efficacy is that the registry record does not report numerical results for the primary endpoint. Group summaries, a between-group estimate, uncertainty intervals, and a hypothesis-test result are absent. The listed Week 28 or early-termination outcome also has no reported numerical result in the record details available.
The analysis-population description is incomplete. It defines the fixed dose full analysis set by treatment, a baseline value, and at least one post-baseline assessment, and states that three participants were excluded. The explanation ends after “no ba,” leaving the complete reason not reported in the registry record. The record does not report how missing values were handled or whether any sensitivity analyses were conducted.
The study’s labels are not fully consistent: allocation is listed as randomized and masking as double, while the model is listed as single group. The official title and arm descriptions identify a randomized placebo-controlled fixed dose period followed by a single-arm open-label period. The reason for the model label is not reported in the registry record. Additional details about randomization, concealment, and masking procedures are also not reported.
Interpretation of the later period is limited by its open-label, single-arm structure. Its participants received sevelamer carbonate, and the record does not describe a concurrent placebo group for this stage. The stated six-month period in the official title and 26-week duration in the arm descriptions are both recorded; dose-titration rules and dose levels are not reported.
Safety interpretation is limited by differing follow-up periods, the absence of exposure-adjusted summaries, and the lack of a stated denominator or group attribution for the listed serious adverse event term percentages. Death counts are not reported in the registry record. The statistical analysis plan, multiplicity approach, sample-size justification, and interim analyses are also not reported.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: An Efficacy and Safety Study of Sevelamer Carbonate in Hyperphosphatemic Pediatric Participants With Chronic Kidney Disease — NCT01574326.
- Registry record last updated 2016-07-25; status last verified 2016-06.
- Results first posted 2016-07-25.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
The registry record describes a completed Phase 2 study with 101 participants enrolled, in pediatric participants with hyperphosphatemia and chronic kidney disease. The official title describes a two-week randomized, placebo-controlled fixed dose period followed by a six-month single-arm, open-label dose-titration period. Arm descriptions specify 26 weeks for the later period. The registry lists randomized allocation and double masking, while its model descriptor is single group.
The primary endpoint is mean change in serum phosphorus from baseline to Week 2, measured in mg/dL. The primary population is the fixed dose full analysis set, defined by treatment and availability of baseline and post-baseline measurements. The record notes three exclusions from that set. The primary numerical result and the listed Week 28 or early-termination outcome result are not reported in the registry record.
Safety counts are listed separately for the fixed dose placebo and sevelamer carbonate groups and the later dose-titration group. Selected serious adverse event terms and percentages are also listed, but their denominator and group attribution are not stated in the available details. The record gives a start date of 2012-05, a primary completion date of 2015-06, and completed status.