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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01496417
Recruitment Status : Active, not recruiting
First Posted : December 21, 2011
Last Update Posted : August 21, 2017
Bristol-Myers Squibb
Information provided by (Responsible Party):
Rolf Barth, University of Maryland

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 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.

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)
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
Study Start Date : March 2012
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Belatacept
U.S. FDA Resources

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 Name: Nulojix

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. Graft survival [ Time Frame: 12 months ]
    Secondary objectives include renal allograft survival at 12 months.

  3. 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.

  4. Patient survival [ Time Frame: 12 months ]
    Secondary objectives include patient survival at 12 months.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01496417

United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland
Bristol-Myers Squibb
Principal Investigator: Rolf N Barth, MD University of Maryland

Additional Information:
Responsible Party: Rolf Barth, Principal Investigator, University of Maryland Identifier: NCT01496417     History of Changes
Other Study ID Numbers: HP00048573
First Posted: December 21, 2011    Key Record Dates
Last Update Posted: August 21, 2017
Last Verified: August 2017

Keywords provided by Rolf Barth, University of Maryland:
Kidney Transplantation

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents