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

June 13, 2018 updated by: Rolf Barth, University of Maryland

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Belatacept therapy
20 Patients receiving belatacept based immunosuppressive protocol for 12 months post-transplantation.
Drug: Belatacept
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 Names:
  • Nulojix

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months
Graft survival
Time Frame: 12 months
Secondary objectives include renal allograft survival at 12 months.
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.
12 months
Patient survival
Time Frame: 12 months
Secondary objectives include patient survival at 12 months.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Maryland

Collaborators

Bristol-Myers Squibb

Investigators

  • Principal Investigator: Rolf N Barth, MD, University of Maryland School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

February 28, 2017

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

December 14, 2011

First Submitted That Met QC Criteria

December 20, 2011

First Posted (Estimate)

December 21, 2011

Study Record Updates

Last Update Posted (Actual)

June 14, 2018

Last Update Submitted That Met QC Criteria

June 13, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP00048573

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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