Subjects receiving a kidney transplant from a living donor or a deceased donor MedDRA version: 9.1 Level: LLT Classification code 10038533 Term: Renal transplant
Conditions
Interventions
Product Name: Belatacept
Pharmaceutical Form: Powder for infusion*
INN or Proposed INN: Belatacept
Current Sponsor code: BMS-224818
Concentration unit: mg milligram(s)
Concentration type: equal
Concen
Sponsors
BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Signed Written Informed Consent a) The subject is willing to provide signed written informed consent 2) Target Population a) The subject must be a recipient of a renal allograft from a living donor or a deceased donor b) The subject will have reliable i.v. access 3) Age and Sex a) Men and women, ages 18 to 70 years, inclusive b) Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study [and for up to 8 weeks after the last dose of investigational product] in such a manner that the risk of pregnancy is minimized. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Donor Exceptions: Donor age 60 years Donor with cardiac death (non-heart beating donor) Cold ischemia time >= 24 hours Donors who are known hepatitis C antibody-positive or polymerase chain reaction (PCR) positive for hepatitis C Donors who are known hepatitis B surface antigen-positive or PCR positive for hepatitis B Donors with known human immunodeficiency virus (HIV) infection - Sex and Reproductive status: 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 dose of investigational product] WOCBP using a prohibited contraceptive method Women who are pregnant or breastfeeding Women with a positive pregnancy test on enrollment or prior to investigational product administration. - Recipient Exceptions: Genetically identical donor recipient pairs (ie, identical twins) Recipients whose serology is negative for EBV (documented at the time of evaluation for transplant) Subjects undergoing primary (first time) renal transplant with current PRA >= 50% or subjects undergoing retransplantation with a PRA > 30% Subjects with prior non-renal solid organ transplant (SOT) (subjects undergoing kidney retransplantation are eligible assuming other study criteria are met), or subjects deemed likely to have a second SOT or cell transplant (eg, pancreas or islet cell) in next 12 months. Subjects who are known hepatitis C antibody-positive or polymerase chain reaction (PCR)-positive for hepatitis C Subjects who are known hepatitis B surface antigen-positive or PCR-positive for hepatitis B Subjects with known human immunodeficiency virus (HIV) infection Subjects at risk for tuberculosis (TB). Body mass index > 35 kg/m2 Subjects who have used any investigational drug within 30 days prior to the Day 1 visit Subjects previously treated with belatacept
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Objective: To assess the rate of AR in different corticosteroid-free belatacept-based immunosuppressive regimens in de novo renal transplant subjects by 6 months post-transplant;Secondary Objective: ? Severity, treatment, and outcome of AR by 6 months ? Incidence of death and graft loss by 12 months ? Incidence, severity, treatment, and outcome of AR by 12 months ? Incidence of AR, death, and graft loss by 6 and 12 months ? Incidence of metabolic and cardiovascular comorbidity (post-transplant diabetes mellitus [PTDM], dyslipidemias, hypertension) by 12 months ? Renal function (calculated GFR) at 12 months ? Proportion of subjects that remain corticosteroid-free at 12 months ? Incidence of discontinuation of study treatment by 12 months ? Overall safety of a belatacept-based corticosteroid-free immunosuppressive regimen.;Primary end point(s): Primary Efficacy Outcome Measures: ? Incidence of AR by 6 months post-transplant. | — |
Countries
Italy, Spain
Outcome results
None listed