Belatacept for Renal Transplant Recipients With Delayed Graft Function

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

TERMINATED

Clinical Phase

EARLY_PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2019-01-18

Brief Summary

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Currently looking for individuals that have received a kidney transplant, are experiencing delayed graft function (DGF), and meet the criteria for study participation.

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Detailed Description

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Patients who undergo kidney transplantation require long term immunosuppressive therapy (therapy that reduces your body's ability to respond to anything foreign) to prevent damage to the graft, and some experience delayed graft function (DGF, a condition in which the transplanted kidney does not function properly) after transplantation. This study is being conducted to determine if kidney transplant recipients with delayed graft function (DGF) who are switched to the immunosuppressive regimen of belatacept with mycophenolate and steroid will recover from delayed graft function (DGF) in less time (which could potentially lower the risk of rejection associated with delayed graft function) than kidney transplant recipients with delayed graft function (DGF) who remain on the current standard immunosuppressive regimen (standard of care).

Conditions

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Delayed Graft Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Belatacept

Belatacept 10mg/kg administered intravenously on days 1, 4, 15, and 28, weeks 8 and 12. Then continue at 5mg/kg every 4 weeks throughout the completion of the study.

Group Type ACTIVE_COMPARATOR

Belatacept

Intervention Type DRUG

Everolimus

Everolimus 1.5 mg/kg twice a day by mouth, the dose will be adjusted after Day 3.

Group Type ACTIVE_COMPARATOR

Everolimus

Intervention Type DRUG

Interventions

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Belatacept

Intervention Type DRUG

Everolimus

Intervention Type DRUG

Other Intervention Names

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NULOJIX zortress

Eligibility Criteria

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Inclusion Criteria

1. Signed Written Informed Consent
2. Deceased donor renal transplant recipient
3. Men and women, aged 18-60 years of age

Exclusion Criteria

1. Seronegative or unknown EBV serostatus
2. Patients unwilling or incapable of providing informed consent.
3. Patients with active tuberculosis or positive TB test without evidence of infection treatment.
4. Patients with demonstrated acute rejection on first biopsy evaluation for delayed graft function; Second transplant or multiple organ transplant; patients more than 12 days post renal transplant prior to enrollment
5. Evidence of Sepsis or other clinical indicators deemed clinically contraindicated for study enrollment by the primary physician
6. Inadequate vein access to receive monthly IV infusions
7. Prior proven allergy or severe adverse drug reaction to mycophenolate, steroid or Belatacept preventing therapy.
8. Pregnant women or women of child bearing age not willing to commit to dual contraception prophylaxis
9. Use of alemtuzumab (Campath 1-H©), basilixumab (Simulect©) and daclizumab (Zenapax©) are not permitted in this protocol; Use of other immunosuppressive agents must be limited to those specified in this protocol.
10. Prisoners or subjects who are involuntarily incarcerated.
11. Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
12. Pre-sensitized patients with alloscreen antibody levels of 80% or more class I or class II

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No