Belatacept for Renal Transplant Recipients With Delayed Graft Function

Early Phase 1

Terminated

• Conditions: Delayed Graft Function
• Interventions: Drug: Everolimus; Drug: Belatacept

• Registration Number: NCT02134288
• Lead Sponsor: Ohio State University

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.

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 Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-21
• Study First Submitted QC: 2014-05-07
• Study First Posted: 2014-05-09
• Primary Completion: 2018-12-11
• Study Completion: 2019-01-18
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-17
• Last Update Posted: 2021-09-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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
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
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
Incidence and type of infection	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
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

Trial Locations

Locations (1)

The Ohio State Universtiy Wexner Medical Center; 🇺🇸 Columbus, Ohio, United States