A Phase II Study of Belatacept (BMS-224818) With a Steroid-free Regimen in Subjects Undergoing Kidney Transplantation

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Disorder Related to Renal Transplantation

Treatments: Drug: Thymoglobulin; Drug: Mycophenolate Mofetil (MMF); Drug: Sirolimus; Drug: Tacrolimus; Drug: Belatacept

Study type: Interventional

Funder types: Industry

Identifiers

NCT00455013

IM103-034

Details and patient eligibility

About

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

Enrollment: 93 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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93 participants in 3 patient groups

belatacept, mycophenolate mofetil (MMF)

Experimental group

Description:

thymoglobulin 1.5mg/kg for 4 days;IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2,4,6,8,10,12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until 12 months; MMF 1g twice daily(bis in die, BID)

Treatment:

Drug: Belatacept

Drug: Thymoglobulin

Drug: Mycophenolate Mofetil (MMF)

belatacept, sirolimus

Experimental group

Description:

thymoglobulin 1.5mg/kg for 4 days;IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2,4,6,8,10,12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until 12 months;sirolimus 5 mg/day on Day 1 (day of transplant)and continued through Day 2, dosing to be adjusted to keep pre-dose C0 levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until 12 months.

Treatment:

Drug: Sirolimus

Drug: Belatacept

Drug: Thymoglobulin

tacrolimus, MMF

Other group

Description:

(IMPs as comparator regimen)thymoglobulin 1.5mg/kg for 4 days; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.

Treatment:

Drug: Tacrolimus

Drug: Thymoglobulin

Drug: Mycophenolate Mofetil (MMF)