Belatacept in Renal Transplantation With Intermediate Risk Maryland Aggregate Pathology Index (MAPI) Scores
This will be a pilot study to investigate the use of belatacept (BMS) therapy in kidney transplant patients who have a MAPI score of greater than or equal to 8. The MAPI (Maryland Aggregate Pathology Index) score is a preimplantation donor scoring system which has five histopathological parameters that impact long-term kidney outcomes. Many kidney transplant recipients use calcineurin inhibitors (CNIs) as one of their anti-rejection medi cations. Kidney function may be affected by anti-rejection medications known as calcineurin inhibitors (CNIs). Sometimes CNIs can lead to toxicities and eventually loss of the kidney or episodes of chronic allograft nephropathy (CAN). Avoiding CNI immunosuppression and using belatacept therapy (BMS) instead, may be associated with improved kidney transplant outcomes.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A 12 Month, Single-center, Non-randomized, Open-label Study of Outcomes of Intermediate Risk Maryland Aggregate Pathology Index (MAPI) Scores in de Novo Renal Transplant Recipients|
- Renal Function [ Time Frame: 12 months ] [ Designated as safety issue: No ]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.
- Rejection rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]Secondary objectives include the biopsy proven rejection rates at 12 months and comparison to existing cohorts of calcineurin inhibitor treated patients.
- Graft survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]Secondary objectives include renal allograft survival at 12 months.
- MAPI biopsy score [ Time Frame: 12 months ] [ Designated as safety issue: No ]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.
- Patient survival [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]Secondary objectives include patient survival at 12 months.
|Study Start Date:||March 2012|
|Estimated Study Completion Date:||April 2014|
|Estimated Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
Experimental: Belatacept therapy
20 Patients receiving belatacept based immunosuppressive protocol for 12 months post-transplantation.
Belatacept infusion intravenous at 10 mg/kg on post-operative days 1, 5, and weeks 2, 4, 8, 12; 5mg/kg intravenous dose at weeks 16, 20, 24, 28, 32, 36, 40, 44, and 48.
Other Name: Nulojix
|Contact: Rolf N Barth, MDfirstname.lastname@example.org|
|Contact: Ilze Sikorski, RNemail@example.com|
|United States, Maryland|
|University of Maryland Medical Center||Not yet recruiting|
|Baltimore, Maryland, United States, 21201|
|Principal Investigator: Rolf N Barth, MD|
|Sub-Investigator: Benjamin Philosophe, MD, PhD|
|Principal Investigator:||Rolf N Barth, MD||University of Maryland|