Belatacept for Renal Transplant Recipients With Delayed Graft Function

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

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

Study Overview

• Status: Terminated
• Conditions: Delayed Graft Function
• Intervention / Treatment: Drug: Belatacept; Drug: Everolimus

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 Type: Interventional
• Enrollment (Actual): 8
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43212
      • The Ohio State Universtiy Wexner Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to recover from Delayed Graft Function	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).	2 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ohio State University
• Collaborators: Bristol-Myers Squibb
• Investigators: Principal Investigator: Jon Von Visger, M.D./Ph.D., OSU Wexner Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2014
• Primary Completion (Actual): December 11, 2018
• Study Completion (Actual): January 18, 2019

Study Registration Dates

• First Submitted: April 21, 2014
• First Submitted That Met QC Criteria: May 7, 2014
• First Posted (Estimate): May 9, 2014

Study Record Updates

• Last Update Posted (Actual): September 23, 2021
• Last Update Submitted That Met QC Criteria: September 17, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Dialysis; Kidney Transplant; immunosuppressive therapy; Delayed Graft Function; Belatacept
• Additional Relevant MeSH Terms: Pathologic Processes; Delayed Graft Function; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Immune Checkpoint Inhibitors; Everolimus; Abatacept
• Other Study ID Numbers: IM103-336; 2013H0312 (Other Identifier: The Ohio State University Wexner Medical Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No