Phase 2
Completed N=89
A Phase II Study of Belatacept (BMS-224818) With a Steroid-free Regimen in Subjects Undergoing Kidney Transplantation
Disorder Related to Renal Transplantation
Source: ClinicalTrials.gov NCT00455013 ↗
Enrolled (actual)
89
Serious AEs
74.2%
Results posted
Nov 2013
Primary outcomePrimary: Number of Participants With Acute Rejection (AR) of Transplant up to 6 Months Post Transplantation - Intent to Treat (ITT) Population — 4; 1; 1; 0 participants
Summary
The purpose of this clinical research study is to learn if belatacept (BMS-224818) is expected to show acceptable rates of acute rejection (AR) in steroid-free belatacept-based immunosuppressive regiments compared to a similar steroid-free tacrolimus regimen. The long-term safety and tolerability of belatacept based regimens following long-term administration in subjects who have received a kidney transplant
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Acute Rejection (AR) of Transplant up to 6 Months Post Transplantation - Intent to Treat (ITT) Population |
4; 1; 1; 0; 0; 0 | — |
| SECONDARY Number of Participants With Acute Rejection of Transplant up to Month 12 Post Transplantation - Intent to Treat Population |
5; 1; 1; 0; 0; 0 | — |
| SECONDARY Number of Participants With Graft Loss or Death up to Month 6 and Month 12 Post Transplantation - Intent to Treat Population |
1; 1; 0; 2; 2; 0 | — |
| SECONDARY Number of Participants With Composite of Death, Graft Loss and Acute Rejection up to Month 6 - Intent to Treat Population |
6; 2; 1 | — |
| SECONDARY Number of Participants With Composite of Death, Graft Loss and Acute Rejection up to Month 12 - Intent to Treat Population |
7; 3; 1 | — |
| SECONDARY Number of Participants With Delayed Graft Function - Intent to Treat Population |
6; 4; 2 | — |
| SECONDARY Number of Participants With New Onset Diabetes Mellitus From Baseline to Month 12 Post Transplantation - Intent to Treat Population |
0; 2; 1 | — |
| SECONDARY Number of Participants Who Used Anti-hypertension Medications at Baseline and at 12 Months Post Transplantation - Intent to Treat Population |
31; 24; 28; 25; 20; 20 | — |
| SECONDARY Mean Systolic, Diastolic and Arterial Blood Pressure at Baseline and Month 12 - Intent to Treat Population |
133.1; 126.9; 141.8; 129.3; 131.0; 138.2 | — |
| SECONDARY Number of Participants Using Antihyperlipidemic Medications at Month 12 - Intent to Treat Population |
11; 10; 9 | — |
| SECONDARY Mean Change From Baseline (BL) to Month 12 Post Transplantation in Lipid Values - Intent to Treat Population |
1.5; -3.7; -0.5; 16.0; 16.1; 20.5 | — |
| SECONDARY Mean (Standard Deviation) in Calculated Glomerular Filtration Rate (GFR) mL/Min/1.73m^2 at Month 3, Month 6 and Month 12 Post Transplantation - Intent to Treat Population |
57.8; 60.5; 51.2; 57.5; 58.7; 51.7 | — |
| SECONDARY Number of Corticosteroid-free Participants at 6 and 12 Months Post Transplantation - Intent to Treat Population |
27; 23; 28; 24; 20; 28 | — |
| SECONDARY Number of Participants Who Were Corticosteroid-free at Months 6 and 12 and Number of Participants Who Were Both Calcineurin Inhibitor-free (CNI-free)and Corticosteroid-free at Months 6 and 12 Post Transplantation - Intent to Treat Population |
27; 23; 28; 24; 20; 28 | — |
| SECONDARY Number of Participants With Acute Rejection of Transplant up to End of Month 48 Post Transplantation - Intent to Treat Population in Long Term Extension |
0; 0; 0 | — |
| SECONDARY Number of Participants With Graft Loss or Death at Months 24, 36, 48 Post Transplantation - Intent to Treat Population in Long Term Extension |
0; 1; 0; 1; 2; 0 | — |
| SECONDARY Mean (Standard Deviation) in Calculated Glomerular Filtration Rate (GFR) mL/Min/1.73m^2 at Months 24, 36 and 48 Post Transplantation - Intent to Treat Population in Long Term Extension |
60.6; 66.0; 52.2; 62.8; 69.9; 55.5 | — |
| SECONDARY Number of Corticosteroid-free Participants at Months 24, 36, 48 Post Transplantation - Intent to Treat Population in Long Term Extension |
22; 15; 25; 22; 14; 20 | — |
| SECONDARY Number of Participants Who Were Both Calcineurin Inhibitor-free (CNI-free)and Corticosteroid-free at Months 24, 36, 48 Post Transplantation - Intent to Treat Population in Long Term Extension |
22; 15; 0; 22; 14; 0 | — |
| SECONDARY Number of Participants Who Switched Between MMF and Sirolimus During Long Term Extension up to Study Completion |
0; 1; 0; 0; 2; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Living or deceased donor renal allograft
- Men and women, 18 to 70 years old
- Subjects who have received a de novo kidney transplant, who have completed the initial study treatment through Month 12, and are willing to sign informed consent will be eligible to continue into the long term extension phase
Exclusion Criteria
- Pregnant or breastfeeding women
- Epstein Barr Virus (EBV) negative serology
- First time renal transplant with panel reactive antibody (PRA) ≥ 50% or retransplantation with PRA > 30%
- Graft loss due to AR
- Positive T-cell or B-cell crossmatch
- Recipients/donors with HIV or hepatitis B/C
- Active tuberculosis (TB)
- Immunosuppressive therapy within 1 year of enrollment
- UNOS ECD organs will be excluded
- Body mass index (BMI) > 35 kg/m²
- Subjects who have developed any malignancy (other than non-melanoma skin cancer) or other medical condition that, in the investigator's opinion, should not be treated with an experimental immunosuppressive drug like belatacept
Data sourced from ClinicalTrials.gov (NCT00455013). 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.