TRANSPLANTATION,NOS
Conditions
Interventions
Product Name: Belatacept
Product Code: BMS-224818
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Belatacept
Current Sponsor code: BMS-224818
Concentration unit: mg milligra
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 recipient of a living donor or deceased donor kidney transplant with an anticipated CIT =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 5) Donor age 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 OR d) Donor with cardiac death (non-heart beating donor) 7) Subjects with underlying renal disease of: a) Primary focal segmental glomerulosclerosis b) Type I or II membranoproliferative glomerulonephritis. c) Hemolytic uremic syndrome (HUS) / thrombotic thrombocytopenic purpura syndrome 8) Subjects undergoing primary (first-time) transplant with a current PRA = 50%, or subjects undergoing retransplantation with a PRA = 30%. 9) Subjects with previous graft loss due to acute rejection. 10) Subjects with a positive T-cell lymphocytotoxic cross match. 11) Subjects with prior non-renal solid organ transplant (subjects undergoing kidney retransplantation are eligible pending other study criteria being met), or subjects undergoing multi-organ transplants (eg, kidney-pancreas) 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. 12) Subjects receiving a concurrent solid organ (heart, liver, pancreas) or cell (islet, bone marrow, stem cell) transplant. 13) Subjects receiving paired kidneys (dual or en bloc kidney transplants). 14) Subjects who are/whose allograft donor was known hepatitis C antibody-positive or polymerase chain reaction (PCR)-positive for hepatitis C 15) Subjects who are/whose allograft donor was known hepatitis B surface antigen-positive or PCR-positive for hepatitis B 16) Subjects and recipients of a graft from a donor with known HIV infection 17) Subjects at risk for tuberculosis (TB). Specifically, subjects who: a) Have current clinical, radiographic or laboratory evidence of active or latent TB b) Have a history of active TB (see Protocol) c) In the opinion of the investigator, a risk of reactivation of TB that precludes the use of conventional immunosuppression. 18) Subjects with any active infection or other contraindication that would normally exclude transplantation. 19) Subjects whose life expectancy is severely limited by disease state or other underlying medical condition. 20) Subjects with a history of cancer (other than non-melanoma skin cell cancers cured by local resection) within the last 5 years. 21) Subjects with a history of substance abuse (drug or alcohol) within the past 5 years, or psychotic disorders that are not compatible with adequate study followup 22) Subjects with active peptic ulcer disease, chronic diarrhea, or gastrointestinal malabsorption. 23) Subjects with laboratory values that meet the following criteria are to be excluded from the study: Hematology: - Hemoglobin 1.5 x upper limit of normal range (ULN); Subjects who have Gilbert’s syndrome and have a normal direct bilirubin are perm
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 < 60 mL/min/1.73 m2 at Month 12 or a decrease in measured GFR = 10 mL/min/1.73 m2 from Month 3 to Month 12. • Evaluate the effects of belatacept, relative to CsA, on the incidence of acute rejection by 12 months. Protocol Amendment 12 - Long-Term Extension: assess the long term safety and tolerability of belatacept in subjects who have received a kidney transplant, completed the Short Term (36 months of treatment in the main study) and remain on study therapy.;Secondary Objective: • Evaluate the effects of belatacept, relative to CsA, on measured GFR at 12 months • Evaluate the effects of belatacept, relative to CsA, on biopsy-proven CAN at 12 months. • Assess the effects of belatacept, relative to CsA, on the individual components of the primary composite endpoint of measured GFR < 60 mL/min/1.73 m2 at Month 12 or a decrease in measured GFR = 10 mL/min/1.73 m2 from Month 3 to Month 12 • Assess the effects of belatacept, relative to CsA, on the triple composite endpoint of death, graft loss, and acute rejection by 12, 24, and 36 months. • Assess the overall safety of belatacept, relative to CsA. Please see the protocol for additional secondary and tertiary objectives. + Additional assessments as per Protocol Amendment 09 - Long-Term Extension (See Protocol Appendix 05, section 2.2);Primary end point(s): The primary efficacy outcome measures will compare each belatacept-based regimen to the CsA-based regimen on: (1) the composite of subject and graft survival by 12 months; (2) the composite of measured GFR < 60 mL/min/1.73 m2 at Month 12 or a decrease in measured GFR = 10 mL/min/1.73 m2 from Month 3 to Month 12; (3) the incidence of acute rejection by 12 months. The primary outcome measures will also be analyzed at Months 24 and 36. The preservat | — |
Countries
Austria, Belgium, Czech Republic, Germany, Hungary, Italy, Portugal, Spain, Sweden, United Kingdom
Outcome results
None listed