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Clinical Trial Details

Trial ID: L0900
Source ID: NCT01496417
Associated Drug: Belatacept
Title: Belatacept in Renal Transplantation With Intermediate Risk Maryland Aggregate Pathology Index (MAPI) Scores
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: End-Stage Renal Disease
Interventions: DRUG: Belatacept
Outcome Measures: Primary: Renal Function, To evaluate renal function in Belatacept treated recipients of intermediate risk MAPI score allografts in terms of estimated glomerular filtration rate (eGFR, calculated using the MDRD formula) assessed at 12 months. The 12 month eGFR will be compared to existing cohorts of calcineurin inhibitor treated patients with MAPI scores above 8., 12 months | Secondary: Rejection rate, Secondary objectives include the biopsy proven rejection rates at 12 months and comparison to existing cohorts of calcineurin inhibitor treated patients., 12 months|Graft survival, Secondary objectives include renal allograft survival at 12 months., 12 months|MAPI biopsy score, Secondary objectives include the MAPI score at 3 and 12 months. The MAPI score change compared to baseline in the study group will be important in comparison to existing cohorts of calcineurin inhibitor treated patients, to determine whether calcineurin free-regimens are associated with both functional and histologic differences as compared to calcineurin based therapies., 12 months|Patient survival, Secondary objectives include patient survival at 12 months., 12 months
Sponsor/Collaborators: Sponsor: University of Maryland | Collaborators: Bristol-Myers Squibb
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 20
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2012-03
Completion Date: 2018-03-01
Results First Posted:
Last Update Posted: 2018-06-14
Locations: University of Maryland, Baltimore, Maryland, 21201, United States
URL: https://clinicaltrials.gov/show/NCT01496417