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 A Study in Maintenance Kidney Transplant Recipients Following Conversion to Nulojix® (Belatacept)-Based (NCT01820572), a randomized phase 3 study. The primary outcome is Percentage of Participants Who Survive With a Functional Graft at 24 Months.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01820572 |
| Phase | Phase 3 |
| Condition | Kidney Transplantation |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 446 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Bristol-Myers Squibb |
| Results posted | Yes |
2. Clinical Question
Population
Maintenance kidney transplant recipients were the population of interest. The stated purpose was to assess changing immunosuppression between 6-60 months after kidney transplant. The primary outcome population is described as all randomized participants. The registry record does not report further eligibility details in the information summarized for this comparison.
Intervention
The intervention was conversion to belatacept-based immunosuppression. Belatacept was administered by intravenous infusion on Days 1, 15, 29, 43 and 57, then every 28 days for 24 months. The listed dose was 5 mg/kg, with a 30 minute infusion.
Comparator
The comparator was a calcineurin-inhibitor-based regimen, abbreviated CNI-Based Regimen in the results. It comprised tacrolimus or cyclosporine, taken orally according to the package insert for 24 months. The listed tacrolimus blood concentration range was 4-11 ng/mL and the listed cyclosporine range was 50-250 ng/mL.
Primary question
Among randomized participants, what percentage survived with a functional graft at 24 months in each group, and what was the reported difference in proportions between groups? The primary endpoint is a combined status at the specified follow-up time; the reported result does not separately describe survival and graft function.
3. Trial Design
This was a Phase 3, randomized, parallel-group trial with no masking. The registry record lists 446 enrolled participants and 223 randomized participants in each primary-outcome arm. The comparison was between conversion to belatacept-based immunosuppression and a CNI-based regimen. Because masking was listed as none, the trial was open-label: treatment assignment was not masked according to the registry record.
The intervention schedule specified belatacept 5 mg/kg as a 30 minute intravenous infusion on Days 1, 15, 29, 43 and 57, followed by dosing every 28 days for 24 months. The comparator included tacrolimus or cyclosporine, orally administered according to the package insert for 24 months. The listed concentration ranges were 4-11 ng/mL for tacrolimus and 50-250 ng/mL for cyclosporine. The registry description does not give further detail about how the choice between those two comparator drugs was made.
The trial record gives a start date of 2013-03-27, a primary completion date of 2019-10-24 and a status of completed. These dates describe the registry record; they do not by themselves specify the follow-up duration of every participant. The primary outcome was assessed at 24 months after randomization. The registry record does not report the randomization procedure, allocation concealment, site structure, or additional details about follow-up and participant flow in the registry record for this analysis.
The trial was sponsored by Bristol-Myers Squibb. The listed condition was kidney transplantation. The posted results include the primary endpoint and multiple secondary outcome measures. The existence of those outcomes does not establish which were prespecified, how they were prioritized, or what statistical procedures were used for each. Those details are not reported in the registry record.
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: 446 Enrolled and Treated
Randomization
| Stage | Belatacept | CNI-Based Regimen |
|---|---|---|
| STARTED | 223 | 223 |
| COMPLETED | 221 | 222 |
| NOT COMPLETED | 2 | 1 |
Reasons for not completing this period:
| Reason | Belatacept | CNI-Based Regimen |
|---|---|---|
| Not Treated | 2 | 1 |
Treatment Period
| Stage | Belatacept | CNI-Based Regimen |
|---|---|---|
| STARTED | 221 | 222 |
| COMPLETED | 195 | 186 |
| NOT COMPLETED | 26 | 36 |
Reasons for not completing this period:
| Reason | Belatacept | CNI-Based Regimen |
|---|---|---|
| Adverse Event | 12 | 7 |
| Death | 3 | 3 |
| Lack of Efficacy | 1 | 0 |
| poor/non compliance | 0 | 3 |
| request to discontinue | 6 | 11 |
| No longer meets study criteria | 3 | 10 |
| withdrew consent | 1 | 2 |
Analysis population for the primary outcome, as defined in the registry: All Randomized Participants
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 | Belatacept | CNI-Based Regimen | Total |
|---|---|---|---|---|
| Participants analysed | 223 | 223 | 446 | |
| Age, Continuous | Years | 55.0 (SD 11.3) | 54.0 (SD 11.7) | 54.0 (SD 11.5) |
| Sex: Female, Male: Female | Participants | 73 | 72 | 145 |
| Sex: Female, Male: Male | Participants | 150 | 151 | 301 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 9 | 15 | 24 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 82 | 79 | 161 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 132 | 129 | 261 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 1 | 3 | 4 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 24 | 24 | 48 |
| Race (NIH/OMB): White | Participants | 191 | 187 | 378 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 7 | 9 | 16 |
6. Primary Endpoint
The registry lists the primary outcome as Percentage of Participants Who Survive With a Functional Graft at 24 Months, measured over at 24 Months.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | 95% Confidence Interval |
| Unit | Percentage |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint was the percentage of participants who survived with a functional graft at 24 months after randomization. It combines two clinically distinct elements—survival and a functioning transplanted kidney—into a single status at a defined follow-up time. Such a composite can provide a concise summary of whether participants are alive and retain graft function at that time. It does not, on its own, show the separate percentage who survived or the separate percentage with a functional graft, nor does it describe when events occurred during follow-up.
The registry record identifies the analysis population as all randomized participants and reports the outcome as a percentage with a 95% confidence interval for each arm. The posted percentages were 98.2 for belatacept and 97.3 for the CNI-based regimen. The reported comparison is a difference in proportions, which places the contrast on an absolute scale rather than expressing a relative ratio. The registry record does not provide the endpoint's operational definition of functional graft, the rules for handling an unavailable 24-month assessment, or details on how deaths and graft outcomes were classified. Those definitions are relevant to interpreting a combined endpoint but are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
At 24 months, the posted percentage who survived with a functional graft was 98.2 in the belatacept group, with a 95% confidence interval from 95.5 to 99.5. In the CNI-based regimen group, it was 97.3, with a 95% confidence interval from 95.2 to 99.4. These are estimates for the randomized groups, and the intervals express uncertainty around each arm's percentage.
The registry's reported difference in proportions was 0.9, with a 95% confidence interval from -8.6 to 10.4. The interval includes zero and extends to values on either side of zero. In general, zero represents no difference on a difference scale. Thus, the posted comparison is not precise enough to distinguish confidently between a difference favoring either group and little or no difference. The interval also shows that the estimate is compatible with a range of possible differences; the point estimate alone should not be treated as the whole result. A p-value is not reported in the registry record.
These results concern the endpoint at 24 months, not the full course of outcomes throughout the trial. They do not provide a time-to-event comparison, and they do not separate survival from graft function. The listed secondary outcomes include graft survival, biopsy-proven acute rejection, changes in calculated glomerular filtration rate, and slope analyses, but the primary result should not be used as a substitute for those distinct measures.
The confidence intervals around the arm percentages overlap, but the comparison of interest is the reported difference between groups, with its own confidence interval. Looking only at the two arm-specific intervals is not a replacement for that direct comparison. The registry record does not report the statistical method used to construct the between-group interval, so its exact assumptions and adjustment procedures cannot be assessed from the reported information.
The result describes the posted estimates for this trial population and follow-up point. It should not be read as proof that the regimens are identical, nor as proof of a clinically important difference. The registry record does not state a margin for equivalence or non-inferiority, and the reported comparison is labeled as a superiority analysis. The direction and precision of the estimate are therefore best described using the reported difference and its confidence interval, without turning the point estimate into a treatment conclusion.
9. Statistical Methods Explained
The primary endpoint is a proportion: each participant is classified according to whether the combined status of survival with a functional graft was met at 24 months, and the result is expressed as a percentage. A proportion is a summary at a particular time point. It is different from a rate that accounts for time at risk, and it does not describe the timing of events before the assessment.
What does a confidence interval communicate?
In general, a confidence interval describes the statistical uncertainty around an estimate under the assumptions of the method used to calculate it. The arm-specific intervals are 95.5 to 99.5 for the belatacept percentage and 95.2 to 99.4 for the CNI-based regimen percentage. The reported 95% confidence interval for the difference in proportions is -8.6 to 10.4. The difference interval is the direct uncertainty summary for the contrast between groups. It includes zero, so the reported data do not narrowly locate the difference on one side of zero.
A confidence interval is not a guarantee that the true value lies within its limits, and it does not describe the range of individual participants' outcomes. Its interpretation depends on the statistical procedure and assumptions used. The registry record does not report the method for calculating the intervals, whether any covariate adjustment was used, or how missing 24-month outcomes were handled. Those details limit a fuller assessment of the interval construction.
Why distinguish the arm estimates from the comparison?
Each group percentage answers a descriptive question about that group. The difference in proportions answers the comparative question. Although the arm estimates are close in the posted results, a direct comparison is required to quantify the contrast and its uncertainty. The reported difference is 0.9, with an interval from -8.6 to 10.4. The interval is broader than the point estimate and spans both negative and positive values. In general, this means the data are compatible with more than one direction of the underlying difference, given the interval's method and assumptions.
The registry record labels the reported analysis as a superiority analysis. A superiority framework asks whether the outcome differs between groups in the direction and manner defined by the analysis. It is not interchangeable with an equivalence or non-inferiority framework. Those frameworks require their own prespecified margins and decision procedures; such margins are not reported in the registry record. The registry also does not report a p-value or the detailed statistical method for the comparison.
What does randomization contribute?
In general, random assignment is intended to make treatment groups comparable with respect to both measured and unmeasured characteristics, on average. It supports a group-level comparison, but it does not guarantee that every characteristic is balanced in a particular trial. The record lists randomized allocation and equal numbers in the two primary-outcome groups. It does not describe the sequence-generation method, concealment of assignment, or any stratification factors. No additional claims about the implementation of randomization can therefore be made from the registry record.
The design was parallel and unmasked. In an unmasked trial, participants and relevant trial personnel know the assigned regimen, according to the stated masking description. In general, knowledge of assignment can affect aspects of trial conduct, assessment, reporting, or care. The extent of any such effect cannot be determined from the reported endpoint figures. The registry record does not say whether endpoint classification was independently reviewed or blinded.
How should the planning illustrations be understood?
In general, sample-size planning calculations describe how many participants might be needed under specified assumptions to detect an effect with a chosen error rate and power. The planning assumptions stated for this analysis use a two-sided significance level of 0.05, equal allocation, a normal approximation, and effects defined as fractions of the observed effect. These are planning illustrations based on the observed effect, not evidence that the trial was designed using those assumptions. They are not observed power, and they do not change the interpretation of the posted confidence interval. The registry record does not report the trial's own sample-size justification or design assumptions.
The outcome is a count-derived percentage, and small counts of outcome failures can make estimates sensitive to individual observations. This is a general consideration for proportions when the outcome is common. The posted confidence intervals provide an uncertainty summary, but the registry does not report the calculation method needed to assess whether it accounts for sparse outcomes or uses a particular approximation.
The record lists 18 outcome measures, two analyses and 17 posted secondary outcomes. In general, assessing many outcomes can raise multiplicity concerns: if many hypotheses are tested, the chance of at least one apparently notable result can increase unless the analysis plan accounts for that. The record does not report whether multiplicity adjustment was planned or applied, nor does it give a hierarchy for interpreting the secondary outcomes. Consequently, those outcomes should be understood individually and in light of the unreported analysis plan, rather than treated as a single confirmatory body of evidence.
10. Analyses Reported by the Sponsor
| Method | Estimate | 95% CI | P-value |
|---|---|---|---|
| not stated | Difference in proportions 0.9 | -8.6 to 10.4 | not reported |
The registry record reports a difference in proportions of 0.9, with a 95% confidence interval from -8.6 to 10.4, for the primary comparison. It labels this a superiority analysis. The registry record does not report the statistical method used for that analysis, and no p-value is listed. The posted arm percentages are 98.2 for belatacept and 97.3 for the CNI-based regimen.
The discrepancy flag for this result is false. Accordingly, there is no recorded discrepancy requiring a recalculated estimate to take precedence over the reported analysis. The figures are the registry's reported comparison; the record does not identify a separate recalculated result or explain a distinct sponsor analysis method. The sponsor's name is Bristol-Myers Squibb, but the available record does not provide further detail on who conducted the analysis or its technical implementation.
In general, a recalculation from summary statistics can be useful as a check, but it may not reproduce an adjusted or otherwise model-based analysis. Without the original method, analysis population details beyond the stated all-randomized population, and handling of missing observations, a numerical comparison of methods cannot be made. The reported confidence interval remains the appropriate result to quote from the registry record.
11. Multiplicity, Missing Data and Analysis Populations
The registry record lists 18 outcome measures, including the primary endpoint and secondary measures such as biopsy-proven acute rejection, graft status, calculated glomerular filtration rate, and slope analyses. It also lists two analyses and 17 posted secondary outcomes. This breadth matters because multiple outcomes can generate multiple opportunities to observe a result that appears notable. In general, a prespecified hierarchy or multiplicity adjustment can help control interpretation across several comparisons. Whether either approach was used is not reported in the registry record.
The primary endpoint population is described as all randomized participants. That label identifies the intended population for the endpoint, but the record does not provide detailed participant flow or explain whether every randomized participant contributed an observed 24-month outcome. It does not report how missing endpoint data were handled, whether any imputation was used, or whether sensitivity analyses assessed the effect of missing observations. The endpoint classification rules for participants without an assessment are also not reported in the registry record.
These omissions affect how completely the result can be audited. For a percentage measured at a fixed follow-up point, the denominator and treatment of missing outcomes are important to understanding the estimate. The arm sizes listed for the primary outcome are 223 in each group, while the adverse-event groups have different at-risk counts. Those counts concern different summaries and should not be assumed to define the same analysis population.
The registry record does not report an interim-analysis plan, stopping boundaries, a prespecified statistical analysis plan, or the method for adjusting for multiple outcomes. Their absence from the record does not establish that such procedures were or were not used. It means the posted information is insufficient to determine how multiplicity, missingness, or interim monitoring were addressed.
12. 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 |
|---|---|---|---|
| Belatacept | 107 | 221 | 48.4% |
| CNI-Based Regimen | 95 | 222 | 42.8% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Belatacept | 4 of 221 |
| CNI-Based Regimen | 5 of 222 |
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 |
|---|---|
| Belatacept | 174 of 221 |
| CNI-Based Regimen | 168 of 222 |
Most frequent serious adverse event terms
| Event term | Organ system | Belatacept | CNI-Based Regimen |
|---|---|---|---|
| Kidney transplant rejection | Immune system disorders | 19 of 221 | 7 of 222 |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 11 of 221 | 5 of 222 |
| Urinary tract infection | Infections and infestations | 7 of 221 | 7 of 222 |
| Pneumonia | Infections and infestations | 5 of 221 | 7 of 222 |
| Urosepsis | Infections and infestations | 6 of 221 | 3 of 222 |
| Acute kidney injury | Renal and urinary disorders | 4 of 221 | 5 of 222 |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 3 of 221 | 5 of 222 |
| Diarrhoea | Gastrointestinal disorders | 1 of 221 | 6 of 222 |
| Gastroenteritis | Infections and infestations | 1 of 221 | 6 of 222 |
| Sepsis | Infections and infestations | 4 of 221 | 2 of 222 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Belatacept | CNI-Based Regimen |
|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | 47 of 221 | 61 of 222 |
| Nasopharyngitis | Infections and infestations | 44 of 221 | 50 of 222 |
| Urinary tract infection | Infections and infestations | 37 of 221 | 33 of 222 |
| Oedema peripheral | General disorders | 22 of 221 | 35 of 222 |
| Cough | Respiratory, thoracic and mediastinal disorders | 31 of 221 | 20 of 222 |
| Headache | Nervous system disorders | 27 of 221 | 23 of 222 |
| Hypertension | Vascular disorders | 29 of 221 | 21 of 222 |
| Arthralgia | Musculoskeletal and connective tissue disorders | 21 of 221 | 23 of 222 |
| Bronchitis | Infections and infestations | 23 of 221 | 18 of 222 |
| Back pain | Musculoskeletal and connective tissue disorders | 18 of 221 | 22 of 222 |
Serious events with the highest arm-level rate: kidney transplant rejection (8.6%), basal cell carcinoma (5.0%), urinary tract infection (3.2%), pneumonia (3.2%), urosepsis (2.7%).
The adverse-event information lists serious adverse events for groups with 221 participants at risk in the belatacept group and 222 at risk in the CNI-based regimen group. The numbers affected by serious adverse events were 107 and 95, respectively. The listed numbers affected by other adverse events were 174 and 168. Deaths were listed for 4 participants in the belatacept group and 5 in the CNI-based regimen group. These are counts, not comparative estimates adjusted for follow-up or participant characteristics.
The most frequently listed serious terms included kidney transplant rejection (8.6%), basal cell carcinoma (5.0%), urinary tract infection (3.2%), pneumonia (3.2%), urosepsis (2.7%) and diarrhoea (2.7%). The registry record does not provide further detail about the event definitions, exposure-adjusted rates, timing, severity grading, or how repeated events were counted. The percentages should therefore be read as posted event summaries, not as a complete account of the safety profile or a direct estimate of comparative risk.
Safety counts and the primary endpoint answer different questions. The primary endpoint is a 24-month status measure, while adverse-event summaries concern recorded events and have their own at-risk denominators. The numbers at risk for these summaries differ from the 223 per arm listed for the primary result. No unreported denominator should be inferred, and the counts alone do not establish a causal relationship between a regimen and an event.
13. What the Result Does, and Does Not, Mean
The primary result describes a high posted percentage of participants in each randomized group who survived with a functional graft at 24 months: 98.2 for belatacept and 97.3 for the CNI-based regimen. The registry's reported difference in proportions is 0.9, with a 95% confidence interval from -8.6 to 10.4. The interval includes zero and covers values in both directions. The estimate should therefore be interpreted together with its uncertainty rather than as a definitive ranking of the groups.
The result does not establish equivalence between the regimens. Equivalence requires a prespecified margin and an analysis designed to assess whether the plausible difference falls within that margin; such a margin is not reported in the registry record. Nor does this result establish non-inferiority, which also requires a prespecified margin and corresponding analysis. The registry labels the reported comparison as superiority, but the detailed method and decision criteria are not reported.
The endpoint combines survival and functional graft status at one follow-up point. It does not show each component separately, the timing of events, or changes in kidney function during follow-up. Secondary outcomes listed in the record address some distinct questions, including rejection and calculated glomerular filtration rate, but their presence does not alter the meaning of the primary measure.
Because the record does not report missing-data procedures, detailed endpoint rules, or the statistical method for the confidence interval, some aspects of the estimate cannot be independently evaluated from the posted summary. The results describe the randomized groups and endpoint as recorded; they do not establish what would happen in every patient or setting. This statistical interpretation is about the reported data and their precision, not a recommendation about treatment choices.
14. Why This Trial Matters Statistically
This trial is statistically informative because it compares two immunosuppression strategies in a randomized, parallel-group design and reports an absolute between-group contrast for a defined endpoint. Reporting both group percentages and the difference with its confidence interval supports a more complete interpretation than relying on either group estimate alone. The interval makes visible the uncertainty around the primary comparison and shows why the point estimate should not be read in isolation.
The trial also illustrates why endpoint definition matters. Survival with a functional graft is a combined status at 24 months, not a direct account of survival, graft function and event timing as separate outcomes. Other listed measures address different aspects of outcome, including acute rejection and calculated glomerular filtration rate. Those measures may provide complementary information, but the registry record does not report a complete hierarchy or statistical plan for interpreting them together.
The unmasked design and the missing reporting details are also relevant to statistical reading. Randomization supports a comparative design, while lack of masking and unreported outcome-assessment procedures leave questions about how assessments were conducted. The available record does not describe missing-data handling, multiplicity adjustment, or the method underlying the primary confidence interval. Recognizing these limits prevents overinterpretation without dismissing the reported estimates.
Finally, the confidence interval demonstrates the distinction between a point estimate and precision. A small-looking point estimate is not, by itself, evidence that groups are the same; nor does an interval spanning zero establish that a difference is absent. Interpreting the estimate, its uncertainty, the endpoint, and the analysis details together is central to reading a registry result responsibly.
15. 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.
Several trial-specific details needed for a full statistical appraisal are not reported in the registry record. These include the randomization procedure, allocation concealment, the operational definition of a functional graft, and the rules for assigning endpoint status when a 24-month assessment is unavailable. The record names all randomized participants as the primary population but does not provide detailed participant flow or explain how missing outcome data were handled.
The record does not state the method used to estimate the between-group difference or construct its confidence interval. It does not report whether covariates were adjusted for, whether any stratification was used, or whether the analysis followed a prespecified statistical plan. A p-value is also not reported. The reported interval can be interpreted as an uncertainty summary, but the exact assumptions behind it cannot be checked from the registry entries.
The primary outcome is a combined status at 24 months, and the posted summary does not separate survival from functional graft status or describe event timing. This limits the questions that can be answered from the primary result. Although several secondary outcomes are listed, the record does not report a statistical hierarchy, multiplicity procedures, or whether secondary analyses were exploratory or confirmatory.
For safety, the posted counts use at-risk denominators that differ from the primary arm sizes. The record does not provide exposure-adjusted rates, detailed event timing, or the counting rules for repeated events in the information available for this analysis. The listed serious-event terms and percentages therefore cannot answer every comparative safety question.
The registry record also does not report the trial's sample-size justification, interim-analysis plan, or stopping rules. These specific omissions limit assessment of how the trial was planned and monitored. They should not be replaced with assumptions based on the observed result or on generic statistical practice.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: A Study in Maintenance Kidney Transplant Recipients Following Conversion to Nulojix® (Belatacept)-Based — NCT01820572.
- Registry record last updated 2021-01-05; status last verified 2020-12.
- Results first posted 2021-01-05.
- 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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19. Record Summary
The registry record describes a completed Phase 3 randomized, open-label, parallel-group trial in maintenance kidney transplant recipients. It compared conversion to belatacept-based immunosuppression with a CNI-based regimen. Enrollment was 446, with 223 participants in each group for the primary endpoint. The primary outcome was survival with a functional graft at 24 months.
The posted percentages were 98.2 for belatacept and 97.3 for the CNI-based regimen. The reported difference in proportions was 0.9, with a 95% confidence interval from -8.6 to 10.4. The interval includes zero and spans values in either direction. The registry record does not report a p-value or the method used for this comparison.
Secondary outcomes include rejection and kidney-function measures. Safety summaries list serious and other adverse events and deaths. Details about missing-data handling, multiplicity, and the trial's statistical plan are not reported in the registry record.