Belatacept for Renal Transplant Recipients With Delayed Graft Function

Sponsor

Ohio State University (Other)

Overall Status

Terminated

CT.gov ID

NCT02134288

Collaborator

Bristol-Myers Squibb (Industry)

Enrollment

Location

Arms

57.6

Actual Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Delayed Graft Function	Drug: Belatacept Drug: Everolimus	Early Phase 1

Detailed Description

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).

Study Design

Study Type:

Interventional

Actual Enrollment :

8 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Prospective, Randomized Trial of Belatacept Switch in Renal Transplant Recipients With Delayed Graft Function

Actual Study Start Date :

Apr 1, 2014

Actual Primary Completion Date :

Dec 11, 2018

Actual Study Completion Date :

Jan 18, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Drug: Belatacept Other Names: NULOJIX
Active Comparator: Everolimus Everolimus 1.5 mg/kg twice a day by mouth, the dose will be adjusted after Day 3.	Drug: Everolimus Other Names: zortress

Arm

Intervention/Treatment

Active Comparator: 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.

Drug: Belatacept

Other Names:

NULOJIX

Active Comparator: Everolimus

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

Drug: Everolimus

Other Names:

zortress

Outcome Measures

Primary Outcome Measures

Time to recover from Delayed Graft Function [2 weeks]
For renal transplant recipients with DGF, time (days) to recover from DGF as defined as: date of enrollment (day 1) until calculated MDRD IV eGFR at least 21 ml/min: at least 2 days after last dialysis if meeting dialysis criteria for enrollment (end date) and no requirement for dialysis at least 2 weeks, with a stable or improving MDRD calculated eGFR (assessed weekly for at least three weeks).

Secondary Outcome Measures

Percent patients reaching recovery (defined above) by 14 days and 3 months. [Assessed at 3, 6, 12 months]
Percent patients reaching recovery (defined above) by 14 days and 3 months.
Hospital length of stay (days) from date of transplant to discharge [up to 7 days]
by monitoring patient while inpatient
Number of dialysis treatments [Assessed at 3, 6, 12 months]
by monitoring patients health at each visit, and notification of hospitalizations/AE's
Number of biopsies [Assessed at 3, 6, 12 months]
medical record review of clinically indicated renal allograft biopsies performed within the followup 12 month period
Biopsy proven acute rejection events [Assessed at 3, 6, 12 months]
by blood draws, and by monitoring patients health at each visit, and notification of hospitalizations/AE's
Patient and graft survival [Assessed at 3, 6, 12 months]
by monitoring patients health at each visit, and notification of hospitalizations/AE's
Number of hospital readmissions [Assessed at 3, 6, 12 months]
by monitoring patients health at each visit, and notification of hospitalizations/AE's
Detection of DSA (Luminex) [Assessed at 3, 6, 12 months]
by blood draw
Incidence and type of infection [Assessed at 3, 6, 12 months]
by monitoring patients health at each visit, and notification of hospitalizations/AE's
Measured or estimated creatinine clearance. [Assessed at 3, 6, 12 months]
by blood draw
Banff score of rejection episodes and immune suppression treatment/management of rejection [Assessed at 3, 6, 12 months]
by monitoring patients health at each visit, and notification of hospitalizations/AE's
Immune suppression drug levels (everolimus or sirolimus, cyclosporine, or mycophenolate as clinically monitored). [Assessed at 3, 6, 12 months]
by blood draw, and by monitoring patients health at each visit, and notification of hospitalizations/AE's

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Seronegative or unknown EBV serostatus
Patients unwilling or incapable of providing informed consent.
Patients with active tuberculosis or positive TB test without evidence of infection treatment.
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
Evidence of Sepsis or other clinical indicators deemed clinically contraindicated for study enrollment by the primary physician
Inadequate vein access to receive monthly IV infusions
Prior proven allergy or severe adverse drug reaction to mycophenolate, steroid or Belatacept preventing therapy.
Pregnant women or women of child bearing age not willing to commit to dual contraception prophylaxis
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.
Prisoners or subjects who are involuntarily incarcerated.
Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
Pre-sensitized patients with alloscreen antibody levels of 80% or more class I or class II