Phase 2
Completed N=173
A Study of BMS-224818 (Belatacept) in Patients Who Have Undergone a Kidney Transplant and Are Currently on Stable Cyclosporine or Tacrolimus Regimen With or Without Corticosteroids
Renal Transplant
Source: ClinicalTrials.gov NCT00402168 ↗
Enrolled (actual)
173
Serious AEs
45.0%
Results posted
Jan 2017
Primary outcomePrimary: Mean Change From Baseline in Calculated Glomerular Filtration Rate (GFR) With Imputed Values to 12 Months Post Randomization - All Randomized Participants (Intent-to-Treat Population) — 7.0; 2.1 mL/min/1.73 m^2
Summary
The purpose of this study is to learn if conversion to belatacept from cyclosporine or tacrolimus will preserve kidney function in people who have had a kidney transplant. The safety and tolerability of this treatment will also be studied
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Calculated Glomerular Filtration Rate (GFR) With Imputed Values to 12 Months Post Randomization - All Randomized Participants (Intent-to-Treat Population) |
7.0; 2.1 | — |
| SECONDARY Mean Change From Baseline in Calculated Glomerular Filtration Rate (GFR) With Imputed Values to 6 Months Post Randomization - All Randomized Participants (Intent-to-Treat Population) |
6.9; 1.1 | — |
| SECONDARY Number of Participants With Acute Rejection (AR) by Months 6 and 12 Post Randomization - All Randomized Participants |
6; 0; 1; 0; 1; 0 | — |
| SECONDARY Percentage of Participants Surviving With a Functioning Graft, Have Graft Loss or Death (Graft Loss, Death, Death With Functioning Graft) By Month 6 and Month 12 Post Randomization |
100.0; 98.9; 0.0; 1.1; 0.0; 0.0 | — |
| SECONDARY Number of Participants Who Had Any Study Drug Dose Alteration by Month 12 Due to Any Reason - Randomized and Treated Participants |
15; 62; 0; 4; 0; 0 | — |
| SECONDARY Percentage of Participants With a Composite Endpoint of Death, Graft Loss and Acute Rejection at Month 12 |
7.1; 1.1 | — |
| SECONDARY Percentage of Participants With New Onset Diabetes Mellitus - All Randomized Participants |
1.7; 2.9 | — |
| SECONDARY Number of Participants With Anti-Donor Human Leukocyte Antigen (HLA) Positive Antibodies |
3; 3; 3; 4; 3; 4 | — |
| SECONDARY Mean Change From Baseline to Month 6 and to Month 12 in Serum Creatinine - All Randomized Participants |
-0.1; -0.0; -0.1; -0.0 | — |
| SECONDARY Number of Participants With Serious Adverse Events (SAEs), Deaths, and Discontinuation Due to Adverse Events (AEs) From First Dose up to Month 12 |
0; 1; 20; 17; 9; 4 | — |
| SECONDARY Mean Change From Baseline in SF-36 Questionnaire Physical Component Score and in Mental Component Score at Month 12 - All Randomized Participants |
0.3; -0.7; 0.5; 0.8 | 0.4491 |
| SECONDARY Mean Change From Baseline to Month 12 for Eight Domain Scores of Quality of Life (QoL) Instrument SF-36 - All Randomized Participants |
0.7; 0.3; 1.6; 0.9; 0.7; -0.1 | — |
| SECONDARY Ridit Score at Month 12 - All Randomized Participants |
0.5162; 0.5014; 0.5074; 0.4998 | — |
| SECONDARY Number of Participants Meeting Marked Laboratory Abnormality Criteria From Baseline up to Month 12 - Randomized and Treated Participants |
0; 1; 4; 0; 0; 1 | — |
| SECONDARY Long Term Period: Mean Change From Baseline to 54 Months Post Randomization in Calculated GFR on Imputed Values at Specified Timepoints - Intent to Treat (ITT) Participants Who Entered LT Period |
5.1; 0.4; 7.1; 2.3; 7.1; 2.8 | — |
| SECONDARY Long Term Period: Number of Participants With Acute Rejection (AR) - All Randomized Participants in LT Period |
5; 4; 0; 0; 1; 1 | — |
| SECONDARY Long Term Period: Number of Participants Who Survived With a Functioning Graft or Survived With Pure Graft Loss or Death With Functioning Graft - ITT Participants Who Entered the LT Period |
80; 80; 1; 1; 1; 1 | — |
| SECONDARY Long Term Period: Percentage of Participants With New Onset Diabetes Mellitus Up to Month 36- All Randomized Participants Who Entered LT Period |
6.9; 4.8 | — |
| SECONDARY Long Term Period: Number of Participants With SAEs, Death, Discontinuation Due to AEs - All Randomized Participants Who Entered the Long Term Period |
4; 0; 45; 40; 18; 14 | — |
| SECONDARY Long Term Period: Number of Participants With AEs of Special Interest - All Randomized Participants Who Entered the Long Term Period |
8; 9; 26; 26; 3; 0 | — |
| SECONDARY Long Term Period: Mean Change From Baseline to Month 54 in Serum Creatinine- ITT Participants Who Entered LT Period |
-0.1; 0.0; -0.1; -0.0; -0.1; -0.0 | — |
| SECONDARY Long Term Period: Number of Participants Meeting Marked Laboratory Abnormality Criteria - All ITT Participants Who Entered the Long Term Period |
1; 0; 1; 1; 0; 1 | — |
| SECONDARY Long Term Period: Mean Change From Baseline to Month 54 in Systolic Blood Pressure |
-3.6; -0.4; -4.6; -4.2; -4.4; 9.0 | — |
| SECONDARY Long Term Period: Mean Change From Baseline to Month 54 in Diastolic Blood Pressure |
-2.0; -2.2; -2.5; -1.0; -1.7; 10.0 | — |
| SECONDARY Participants Who Switched From CNI to Belatacept in Long Term Period : Mean Change in Calculated GFR Based on Imputed Values From Day of Switch to Week 96 Post Switch |
1.3; 3.3; 2.1; 0.3; 0.1 | — |
| SECONDARY Participants Who Switched to Belatacept in Long Term Period: Number of Participants With AEs and SAEs |
32; 9 | — |
Eligibility Criteria
Key Inclusion Criteria
- Men and women age 18 and older
- 6-36 months after kidney transplant receiving cyclosporine or tacrolimus
- calculated GFR ≥35 and ≤75mL/min/1.73 m²
- subjects must have completed 1 year in the IM103-010ST and remained on study treatment (Long Term Extension)
Key Exclusion Criteria
- Significant infection
- acute rejection within 3 months
- prior graft loss due to rejection
- pregnancy
- positive crossmatch
Data sourced from ClinicalTrials.gov (NCT00402168). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.