Belatacept in Renal Transplantation With Intermediate Risk Maryland Aggregate Pathology Index (MAPI) Scores

University of Maryland

Status

Completed

Conditions

End-Stage Renal Disease

Treatments

Drug: Belatacept

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01496417

HP00048573

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female renal recipients 18-70 years of age undergoing primary kidney transplantation.
Recipients of deceased donor (including expanded criteria donor organs and deceased donor organs after cardiac death) with MAPI score ≥ 8.
Cold ischemic time less than 40 hours at time of reperfusion.
Negative serum pregnancy test for female patients.
Patients who can understand the purposes and risks of the study, provide informed consent, and can comply with the treatment and follow-up requirements.

Exclusion criteria

Cold ischemic time (CIT) > 40 hours
Patients who are sensitized with current PRA>40%, ABO incompatible transplants, or T, or B cell crossmatch positive transplant.
Patients without antibody to EBV
Patients receiving multiple organ transplants.
Patients unable to take oral medication at time of randomization
Patient with a history of malignancy of any organ system, treated or untreated, within the past 2 years whether or not there is evidence of local recurrence or metastases, with the exception of carcinoma in situ
Patients who tested positive for HIV, Hepatitis C or Hepatitis B surface antigen.
Recipients of organs from donors who test positive for HIV, Hepatitis C or Hepatitis B surface antigen
Patients with a clinically significant systemic infection within 30 days prior to transplant
Patients who have cardiac failure at time of screening or any other severe cardiac disease as determined by the investigator
Patients with abnormal laboratory findings of clinical significance within 2 weeks of randomization which would interfere with the objectives of the study.
Females, pregnant or lactating, or are of childbearing potential unwilling to use an effective means of contraception or are planning to become pregnant.
Patient with active tuberculosis infection