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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Maryland
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Rolf Barth, MD, University of Maryland
ClinicalTrials.gov Identifier:
NCT01496417
First received: December 14, 2011
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

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 Intervention
End-Stage Renal Disease
Drug: Belatacept

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • Renal Function [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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:
  • Rejection rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Secondary objectives include renal allograft survival at 12 months.

  • MAPI biopsy score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Secondary objectives include patient survival at 12 months.


Estimated Enrollment: 20
Study Start Date: March 2012
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01496417

Contacts
Contact: Rolf N Barth, MD 4438412222 rbarth@smail.umaryland.edu
Contact: Ilze Sikorski, RN 4103280303 isikorski@smail.umaryland.edu

Locations
United States, Maryland
University of Maryland Recruiting
Baltimore, Maryland, United States, 21201
Contact: Rolf Barth, MD    410-328-6020    rbarth@smail.umaryland.edu   
Principal Investigator: Rolf Barth, MD         
University of Maryland Recruiting
Baltimore, Maryland, United States, 21201
Contact: Rolf Barth, MD    410-328-6020    rbarth@smail.umaryland.edu   
Contact: Ilze Sikorski, RNBSN    410-328-0303    isikorski@smail.umaryland.edu   
Principal Investigator: Rolf Barth, MD         
Sponsors and Collaborators
University of Maryland
Bristol-Myers Squibb
Investigators
Principal Investigator: Rolf N Barth, MD University of Maryland
  More Information

Additional Information:
Publications:
Responsible Party: Rolf Barth, MD, Principal Investigator, University of Maryland
ClinicalTrials.gov Identifier: NCT01496417     History of Changes
Other Study ID Numbers: HP00048573
Study First Received: December 14, 2011
Last Updated: May 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Maryland:
Kidney Transplantation
Biopsy
Belatacept

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Urologic Diseases

ClinicalTrials.gov processed this record on October 23, 2014