Belatacept Conversion Trial in Renal Transplantation

简要总结

主要结局

次要结局

• Number of Participants With Acute Rejection (AR) by Months 6 and 12 Post Randomization - All Randomized Participants(At 6 and 12 months post randomization)
• Percentage of Participants With a Composite Endpoint of Death, Graft Loss and Acute Rejection at Month 12(12 Months post randomization)
• Number of Participants Who Had Any Study Drug Dose Alteration by Month 12 Due to Any Reason - Randomized and Treated Participants(Month 12)
• Mean Change From Baseline to Month 6 and to Month 12 in Serum Creatinine - All Randomized Participants(Baseline to Month 6 and Month 12 Post Randomization)
• Long Term Period: Mean Change From Baseline to 54 Months Post Randomization in Calculated GFR on Imputed Values at Specified Timepoints - Intent to Treat (ITT) Participants Who Entered LT Period(Baseline, Month 3, 6, 12, 18, 24, 30, 36, 42, 48, 54)
• Percentage of Participants Surviving With a Functioning Graft, Have Graft Loss or Death (Graft Loss, Death, Death With Functioning Graft) By Month 6 and Month 12 Post Randomization(At 6 and 12 months post randomization)
• Percentage of Participants With New Onset Diabetes Mellitus - All Randomized Participants(Month 12 post randomization)
• Long Term Period: Percentage of Participants With New Onset Diabetes Mellitus Up to Month 36- All Randomized Participants Who Entered LT Period(Baseline (screening) up to Month 36 post randomization)
• Long Term Period: Mean Change From Baseline to Month 54 in Serum Creatinine- ITT Participants Who Entered LT Period(Baseline, Months 3, 6, 12, 18, 24, 30, 36, 42, 48, 54)
• Participants Who Switched to Belatacept in Long Term Period: Number of Participants With AEs and SAEs(Day of Switch (first dose of belatacept ) to last dose plus 56 days, up to Year 6 of the Study)
• Mean Change From Baseline in Calculated Glomerular Filtration Rate (GFR) With Imputed Values to 6 Months Post Randomization - All Randomized Participants (Intent-to-Treat Population)(Baseline to 6 months post randomization)
• Number of Participants With Anti-Donor Human Leukocyte Antigen (HLA) Positive Antibodies(Month 6 and Month 12 Post Randomization)
• Mean Change From Baseline in SF-36 Questionnaire Physical Component Score and in Mental Component Score at Month 12 - All Randomized Participants(Baseline, Month 12)
• Long Term Period: Number of Participants With SAEs, Death, Discontinuation Due to AEs - All Randomized Participants Who Entered the Long Term Period(First dose after randomization (Day 1) to 56 days post last dose, up to Year 6 of the Study)
• Number of Participants With Serious Adverse Events (SAEs), Deaths, and Discontinuation Due to Adverse Events (AEs) From First Dose up to Month 12(First Dose (Day 1) to Month 12)
• Mean Change From Baseline to Month 12 for Eight Domain Scores of Quality of Life (QoL) Instrument SF-36 - All Randomized Participants(Baseline (screening) to Month 12)
• Ridit Score at Month 12 - All Randomized Participants(Month 12)
• Number of Participants Meeting Marked Laboratory Abnormality Criteria From Baseline up to Month 12 - Randomized and Treated Participants(Baseline up to Month 12)
• Long Term Period: Number of Participants Who Survived With a Functioning Graft or Survived With Pure Graft Loss or Death With Functioning Graft - ITT Participants Who Entered the LT Period(Post Months 24, 36, 48, up to Year 6 of the Study)
• Long Term Period: Mean Change From Baseline to Month 54 in Systolic Blood Pressure(Baseline, Months 6, 12, 18, 24, 30, 36, 42, 48, 54)
• Long Term Period: Number of Participants With Acute Rejection (AR) - All Randomized Participants in LT Period(Post Month 12 up to Year 6 of the Study)
• Long Term Period: Number of Participants With AEs of Special Interest - All Randomized Participants Who Entered the Long Term Period(First dose after randomization (Day 1) to last dose, plus 56 days, up to Year 6 of the Study)
• Long Term Period: Number of Participants Meeting Marked Laboratory Abnormality Criteria - All ITT Participants Who Entered the Long Term Period(Baseline (Screening), up to Year 6 of the Study)
• Long Term Period: Mean Change From Baseline to Month 54 in Diastolic Blood Pressure(Baseline, Months 6, 12, 18, 24, 30, 36, 42, 48, 54)
• Participants Who Switched From CNI to Belatacept in Long Term Period : Mean Change in Calculated GFR Based on Imputed Values From Day of Switch to Week 96 Post Switch(Day of Switch (first belatacept dose) to Week 96 Post Switch)