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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2018-03-01

Brief Summary

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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.

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Detailed Description

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Conditions

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End-Stage Renal Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Belatacept therapy

20 Patients receiving belatacept based immunosuppressive protocol for 12 months post-transplantation.

Group Type EXPERIMENTAL

Belatacept

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Nulojix

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No