Phase 3
N=543
Study of Belatacept in Subjects Who Are Undergoing a Renal Transplant
Renal Transplantation
Bottom Line
View on ClinicalTrials.gov: NCT00114777 ↗Enrolled (actual)
543
Serious AEs
86.7%
Results posted
Jul 2017
Primary outcome: Primary: Percentage of Participants Who Survived With a Graft at 12 Months Post-Transplant — 85.9; 88.0; 84.8 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Cyclosporin A (Drug); Belatacept Less Intensive Regimen (LI) (Drug); Belatacept More Intensive Regimen (MI) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- May 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Survived With a Graft at 12 Months Post-Transplant |
85.9; 88.0; 84.8 | — |
| PRIMARY Percentage of Participants With a Measured Glomerular Filtration Rate (GFR) <60 mL/Min Per 1.73 m^2 at Month 12 or a Decrease in Measured GFR >=10 mL/Min Per 1.73 m^2 From Month 3 to Month 12 |
55.7; 62.1; 67.4; 17.6; 27.2; 24.7 | 0.0018 sig |
| SECONDARY Measured Glomerular Filtration Rate (GFR) by Month 12 and 24 |
52.1; 49.5; 45.2; 51.5; 49.7; 45.0 | — |
| SECONDARY Percentage of Participants With Chronic Allograft Nephropathy (CAN) at Month 12 |
44.8; 46.0; 51.6 | — |
| SECONDARY Percentage of Participants Who Survived With a Graft at 24 and 36 Months Post-Transplant |
82.6; 84.0; 82.6; 80.4; 82.3; 79.9 | — |
| SECONDARY Calculated Glomerular Filtration Rate (GFR) at 6, 12, 24, 36 and 84 Months |
43.6; 43.4; 35.5; 44.4; 44.8; 36.5 | — |
| SECONDARY Change in Calculated GFR at Months 12, 24, 36 and 84 |
-0.7; -0.6; -1.1; -1.4; -1.6; -3.6 | — |
| SECONDARY Number of Participants With Anti-Hypertensive Medications Used to Control Hypertension at 12, 24 and 36 Months |
82; 79; 76; 76; 66; 93 | — |
| SECONDARY Percentage of Subjects Who Used Anti-Hypertensive Medications to Control Hypertension at Months 12, 24 and 36 |
87; 83.4; 87.0; 89.3; 84.7; 89.4 | — |
| SECONDARY Percentage of Participants With New Onset Diabetes Mellitus (NODM) at 12, 24 and 36 Months. |
2.3; 5.1; 9.3; 3.0; 7.4; 9.3 | — |
| SECONDARY Systolic and Diastolic Blood Pressure (BP) at 12, 24 and 36 Months |
77.8; 78.3; 81.8; 141.4; 140.9; 149.5 | — |
| SECONDARY Mean Framingham Risk Score From Baseline to Months 12, 24 and 36 |
5.3; 4.5; 6.0; 5.0; 4.6; 6.2 | — |
| SECONDARY Percentage of Participants Using Lipid-Lowering Therapy at 12, 24, and 36 Months |
43.5; 40.0; 46.2; 47.8; 42.3; 51.1 | — |
| SECONDARY Change in Total Cholesterol (TC), Non-HDL, LDL and HDL Cholesterol and Triglycerides at 12, 24 and 36 |
134.5; 134.2; 153.4; 183.7; 184.1; 201.3 | — |
| SECONDARY Percentage of Participants Who Have an Acute Rejection by Months 6, 12, 24, 36 and 84 |
17.4; 16.6; 13.6; 17.4; 17.7; 14.1 | — |
| SECONDARY Number of Participants Using Lymphocyte Depleting Therapy and Steroid-Resistant for Acute Rejection by Months 6, 12, 24, and 36. |
14; 16; 9; 2; 2; 2 | — |
| SECONDARY Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84 |
0; 4; 2; 6; 2; 2 | — |
| SECONDARY Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36 |
2.1; 3.6; 1.9; 5.2; 6.2; 4.7 | — |
| SECONDARY Number of Participants With Clinically Significant Changes in Vital Signs up to 36 Months |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Laboratory Test Abnormalities up to 36 Months |
25; 24; 16; 2; 1; 2 | — |
| SECONDARY Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs and SAEs, AEs Leading to Discontinuation and Who Died up to Month 36 |
182; 174; 184; 149; 139; 146 | — |
| SECONDARY Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs and SAEs, AEs Leading to Discontinuation and Who Died up to Month 84 |
104; 113; 87; 94; 104; 73 | — |
| SECONDARY Percentage of Participants With Graft Loss or Death to Month 84 |
29.3; 30.9; 28.3; 11.4; 13.1; 15.8 | — |
Summary
The purpose of this trial is to learn if Belatacept is effective and safe as a first line of immunosuppression treatment in patients undergoing a renal transplant where the donor kidney is obtained in patients with extended criteria.
Eligibility Criteria
Inclusion Criteria
- Subject is a first-time recipient of a kidney transplant from a deceased donor.
- Specific donor criteria
Exclusion Criteria
- Donor age <10 years
- Subjects receiving a concurrent solid organ or cell transplant (lung, heart, etc.)
- Subjects with a positive T-cell lymphocytotoxic crossmatch.
- Subjects who are positive for Hepatitis B or C, or HIV
- Active tuberculosis
- History of cancer in the last 5 years
- History of substance abuse
- Specific laboratory results are exclusionary
- Mammography suspicious for cancer
- Allergy to iodine
- For Long-term extension study-Subjects who have completed three years of study treatment (through Week 156)
Data sourced from ClinicalTrials.gov (NCT00114777). 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.