Status:
COMPLETED
Belatacept in Renal Transplantation With Intermediate Risk Maryland Aggregate Pathology Index (MAPI) Scores
Lead Sponsor:
University of Maryland
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
End-Stage Renal Disease
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2018
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01496417
Start Date
March 1 2012
End Date
March 1 2018
Last Update
June 14 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Maryland
Baltimore, Maryland, United States, 21201