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

Condition(s) targeted: Disorder Related to Renal Transplantation

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

Phase: Phase 2

Status: Completed

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

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

Official title: A Randomized, Open-Label, Multicenter, Parallel-Group Study of Belatacept (BMS-224818)-Based Corticosteroid-Free Regimens in Renal Transplant

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Number of Participants With Acute Rejection (AR) of Transplant up to 6 Months Post Transplantation - Intent to Treat (ITT) Population

Secondary outcome:

Number of Participants With Acute Rejection of Transplant up to Month 12 Post Transplantation - Intent to Treat Population

Number of Participants With Graft Loss or Death up to Month 6 and Month 12 Post Transplantation - Intent to Treat Population

Number of Participants With Composite of Death, Graft Loss and Acute Rejection up to Month 6 - Intent to Treat Population

Number of Participants With Composite of Death, Graft Loss and Acute Rejection up to Month 12 - Intent to Treat Population

Number of Participants With Delayed Graft Function - Intent to Treat Population

Number of Participants With New Onset Diabetes Mellitus From Baseline to Month 12 Post Transplantation - Intent to Treat Population

Number of Participants Who Used Anti-hypertension Medications at Baseline and at 12 Months Post Transplantation - Intent to Treat Population

Mean Systolic, Diastolic and Arterial Blood Pressure at Baseline and Month 12 - Intent to Treat Population

Number of Participants Using Antihyperlipidemic Medications at Month 12 - Intent to Treat Population

Mean Change From Baseline (BL) to Month 12 Post Transplantation in Lipid Values - Intent to Treat Population

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

Number of Corticosteroid-free Participants at 6 and 12 Months Post Transplantation - Intent to Treat Population

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

Number of Participants With Acute Rejection of Transplant up to End of Month 48 Post Transplantation - Intent to Treat Population in Long Term Extension

Number of Participants With Graft Loss or Death at Months 24, 36, 48 Post Transplantation - Intent to Treat Population in Long Term Extension

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

Number of Corticosteroid-free Participants at Months 24, 36, 48 Post Transplantation - Intent to Treat Population in Long Term Extension

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

Number of Participants Who Switched Between MMF and Sirolimus During Long Term Extension up to Study Completion

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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

Local Institution, Bologna 40138, Italy

Local Institution, Brescia 25123, Italy

Local Institution, Padova 35128, Italy

Local Institution, Roma 00168, Italy

Local Institution, Barcelona 08907, Spain

Local Institution, Sevilla 41013, Spain

Ucsf, San Francisco, California 94143, United States

Denver Nephrology, Pc, Denver, Colorado 80218, United States

University Of Colorado Health Sciences Center, Denver, Colorado 80262, United States

Medical College Of Georgia, Augusta, Georgia 30912, United States

Northwestern University Feinberg School Of Medicine, Chicago, Illinois 60611, United States

Henry Ford Hospital, Detriot, Michigan 48202, United States

Albany Medical College, Albany, New York 12208, United States

Carolinas Medical Center, Charlotte, North Carolina 28203, United States

University Of Cincinnati, Cincinnati, Ohio 45267, United States

Ohio State University Medical Center, Columbus, Ohio 43210, United States

Vanderbilt University Medical Center, Nashville, Tennessee 37232, United States

BMS Clinical Trials Disclosure

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm

Starting date: July 2007
Last updated: May 27, 2014