Belatacept in Renal Transplantation With Intermediate Risk Maryland Aggregate Pathology Index (MAPI) Scores
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|ClinicalTrials.gov Identifier: NCT01496417|
Recruitment Status : Active, not recruiting
First Posted : December 21, 2011
Last Update Posted : August 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|End-Stage Renal Disease||Drug: Belatacept||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||March 2012|
|Estimated Primary Completion Date :||January 2018|
|Estimated Study Completion Date :||January 2018|
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
- Renal Function [ Time Frame: 12 months ]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 ]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 ]Secondary objectives include renal allograft survival at 12 months.
- MAPI biopsy score [ Time Frame: 12 months ]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 ]Secondary objectives include patient survival at 12 months.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01496417
|United States, Maryland|
|University of Maryland|
|Baltimore, Maryland, United States, 21201|
|Principal Investigator:||Rolf N Barth, MD||University of Maryland|