Phase 2
N=58
Regimen Optimization Study
Kidney Transplantation
Bottom Line
View on ClinicalTrials.gov: NCT02137239 ↗Enrolled (actual)
58
Serious AEs
56.9%
Results posted
Jun 2021
Primary outcome: Primary: Percentage of Clinically-suspected Biopsy-proven Acute Rejection (CSBPAR) at 6 Months — 7.7; 9.4 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Thymoglobulin (Drug); Belatacept (Drug); mycophenolate mofetil(MMF) (Drug); Corticosteroids (Drug); Everolimus(EVL) (Drug); Tacrolimus(TAC) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Clinically-suspected Biopsy-proven Acute Rejection (CSBPAR) at 6 Months |
7.7; 9.4 | — |
| SECONDARY Clinically-suspected Biopsy-proven Acute Rejection (CSBPAR) at 6, 12 and 24 Months |
7.7; 9.4; 11.5; 12.5; 15.4; 12.5 | — |
| SECONDARY Time to Clinically-suspected Biopsy-proven Acute Rejection (CSBPAR). |
NA; NA | — |
| SECONDARY Percentage of Participants With BANFF Grade by Severity Grades. BANFF Type (Grade) for Acute/Active Rejection |
3.8; 0; 0; 3.1; 7.7; 6.3 | — |
| SECONDARY Treatment Differences in Therapeutic Modalities |
7.7; 9.4; 0; 6.3; 0; 0 | — |
| SECONDARY Number of Participants Who Survive With a Functioning Graft |
25; 31; 25; 31; 25; 31 | — |
| SECONDARY Number of Participants Deaths Post Transplant |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants Who Experience Graft Loss Post Transplant |
1; 1; 1; 1; 1; 1 | — |
| SECONDARY Time to Event: Graft Loss and Death |
107; 2 | — |
| SECONDARY Absolute Calculated Glomerular Filtration Rate (cGFR): Mean |
69.2; 62.2; 66.0; 63.9; 66.2; 62.0 | — |
| SECONDARY Median Calculated Glomerular Filtration Rate (cGFR) |
64.0; 62.0; 64.0; 67.0; 66.0; 62.5 | — |
| SECONDARY Mean Change From Month 3 in cGFR |
0; 0; -3.2; 2.8; -3.1; 1.4 | — |
| SECONDARY Urine Protein Creatinine Ratio (UPr/Cr) |
0.3146; 0.1412; 0.3896; 0.1461; 0.2835; 0.1849 | — |
| SECONDARY Percentage of Participants With Donor Specific Anti-HLA Antibodies (DSA) |
10; 0; 0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants With De Novo Donor Specific Anti-HLA Antibodies (DSA) |
10; 0; 0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants With Adverse Events (AEs) |
100.0; 97.0 | — |
| SECONDARY Percentage of Participants With Serious Adverse Events (SAEs) |
52.0; 60.6 | — |
| SECONDARY Percentage of Participants With Events of Special Interest (ESIs) |
16; 15.2; 4.0; 3.0; 0; 0 | — |
| SECONDARY Percentage of Particpants With Laboratory Test Abnormalities (LTAs) |
12.0; 6.1; 0; 3.0; 84.0; 69.7 | — |
| SECONDARY Mean and Mean Change From Baseline in Blood Glucose |
107.2; 107.2; 4.9; 4.8; 101.1; 127.5 | — |
| SECONDARY Mean and Mean Change From Baseline in Whole Blood HbA1c |
6.11; 6.13; 0.34; 0.48; 6.18; 6.21 | — |
| SECONDARY Percentage of Participants With New Onset Diabetes After Transplant |
11.5; 6.3; 11.5; 6.3; 15.4; 12.5 | — |
| SECONDARY Absolute Values of Blood Pressure: Mean |
78.7; 77.7; 134.2; 131.0; 77.4; 79.4 | — |
| SECONDARY Absolute Values of Blood Pressure: Median |
78.5; 80.0; 135.5; 131.0; 75.5; 80.0 | — |
| SECONDARY Mean Changes From Baseline Values for Blood Pressure |
1.0; 4.8; -4.0; -0.7; 2.3; 5.4 | — |
| SECONDARY Absolute Values of Fasting Lipid Values: Mean |
181.2; 174.4; 197.7; 175; 189.0; 169.9 | — |
| SECONDARY Absolute Values of Fasting Lipid Values: Median |
167.0; 173.0; 187.0; 178.0; 184.0; 171.5 | — |
| SECONDARY Mean Changes From Baseline Values of Lipid Values |
25.7; -2.8; 26.6; 10.0; 5.4; 1.9 | — |
Summary
Patients who undergo a kidney transplant require prolonged therapy with drugs that suppress the immune system (called immunosuppressive regimens) to stop the immune system from attacking the transplanted kidney in order to limit damage to or the possibility of rejecting the transplanted kidney. The purpose of this study is to evaluate benefits and risks of two immunosuppressive regimens (belatacept with everolimus or tacrolimus with mycophenolate mofetil) following thymoglobulin induction and rapid corticosteroid withdrawal.
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria
- Men and women, aged 18 to 75
- Serologic test results are positive for past exposure to Epstein Barr Virus (EBV+)
- Diagnosed with end stage renal disease (ESRD) and scheduled to undergo transplantation of a non-HLA identical, living or standard criteria deceased donor kidney
Exclusion Criteria
- Primary cause of ESRD is: primary focal segmental glomerulosclerosis; or Type I or II membranoproliferative glomerulonephritis; or Hemolytic Uremic Syndrome / Thrombotic Thrombocytopenic Purpura
- Had a previous graft loss due to acute rejection
- At increased immunologic risk of graft loss due to panel reactive antibodies (PRA) >20% or need for desensitization therapy
- Scheduled to receive a: kidney from identical twin; or paired kidney; or kidney from a Cytomegalovirus(CMV) positive donor when recipient is CMV negative; or kidney from an extended criteria donor
- Have a body mass index (BMI) of > 35 kg/m2 for nondiabetics or > 30 kg/m2 for diabetics
- Diagnosed as Hepatitis B positive; or Hepatitis C positive; or HIV positive; or currently or previously active or inadequately treated latent
Data sourced from ClinicalTrials.gov (NCT02137239). 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.