TRANSPLANTATION, NOS
Conditions
Interventions
Product Name: BELATACEPT
Product Code: BMS-224818
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Belatacept
Sponsors
Bristol-Myers Squibb International Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) The subject is willing to provide signed written informed consent; 2) The subject is a first-time recipient of a deceased donor kidney transplant; 3) The donor and/or donor kidney meet at least 1 of the following extended criteria for organ donation: a) Donor age >= 60 years OR b) Donor age 50 – 59 years and 1 of the following: (i) Cerebrovascular accident (CVA) + hypertension + SCr > 1.5 mg/dL OR (ii) CVA + hypertension OR (iii) CVA + SCr > 1.5 mg/dL OR (iv) Hypertension + SCr > 1.5 mg/dL OR c) Anticipated CIT >= 24 hours (subjects should not be randomized if actual CIT is =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) WOCBP who are unwilling or unable to use an acceptable method to avoid; pregnancy for the entire study period and for up to 8 weeks after the last infusion. 2) Women who are pregnant or breastfeeding; 3) Women with a positive pregnancy test on enrollment or prior to study drug administration; 4) Genetically-identical donor recipient pairs (ie, identical twins); 5) Donor age = 30%; 8) Subjects with a positive T-cell lymphocytotoxic crossmatch; 9) Subjects with any prior solid organ transplant (including kidney); 10) Subjects receiving a concurrent solid organ (heart, liver, pancreas) or cell (islet, bone marrow, stem cell) transplant or subjects deemed likely to have a second solid organ or cell transplant (eg, pancreas or islet transplant) in the next 3 years by the investigator; 11) Subjects receiving paired kidneys from the extended criteria donor (dual kidney transplant); 12) Subjects who are hepatitis C antibody-positive or polymerase chain reaction (PCR)-positive for hepatitis C; 13) Subjects who are hepatitis B surface antigen-positive or PCR-positive for hepatitis B; 14) Subjects with known human immunodeficiency virus (HIV) infection; 15) Subjects with active tuberculosis (TB) requiring treatment within the previous 3 years or any subject who previously required triple (or more) combination therapy for TB. Subjects with a known positive purified protein derivative (PPD) will not be eligible for the study unless they completed treatment for latent TB and have a negative chest x-ray at the time of enrollment. PPD testing done within the last 12 months is acceptable as long as there is documentation of the results. Subjects without a PPD in the last 12 months who have a previous negative result may be enrolled if they also have a negative chest x-ray at enrollment, no symptoms indicative of TB, no known TB contacts, not currently residing in, recently traveled to, or previously immigrated from an area endemic for TB. A PPD response that is >= 10 mm induration or a Heaf score of > 1 in non-Bacille Calmette-Guérin (non-BCG) immunized subjects or > 2 in BCG immunized subjects should be considered a positive test. More conservative criteria may be applied according to the published guidelines and/or local standards endorsed by the medical society; 16) Subjects with any active infection or other contraindication that would normally exclude transplant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • Evaluate the effects of belatacept, relative to CsA, on the composite of subject and graft survival by 12 months • Evaluate the effects of belatacept, relative to CsA, on the composite of measured GFR = 10 mL/min/1.73 m2 from Month 3 to Month 12; (b) the triple composite endpoint of death, graft loss, and acute rejection by 12, 24, and 36 months. (c) the proportion of subjects with a measured GFR = 10 mL/min/1.73 m2 from Month 3 to Month 12. | — |
Countries
Austria, Belgium, Czech Republic, Germany, Hungary, Italy, Portugal, Spain, Sweden, United Kingdom
Outcome results
None listed