Back to resultsBelatacept for Renal Transplant Recipients With Delayed Graft Function
Primary Purpose
Delayed Graft Function
Status
Terminated
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Belatacept
Everolimus
Sponsored by
About this trial
This is an interventional treatment trial for Delayed Graft Function focused on measuring Dialysis, Kidney Transplant, immunosuppressive therapy, Delayed Graft Function, Belatacept
Eligibility Criteria
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
Sites / Locations
- The Ohio State Universtiy Wexner Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Belatacept
Everolimus
Arm Description
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.
Everolimus 1.5 mg/kg twice a day by mouth, the dose will be adjusted after Day 3.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Percent patients reaching recovery (defined above) by 14 days and 3 months.
Percent patients reaching recovery (defined above) by 14 days and 3 months.
Hospital length of stay (days) from date of transplant to discharge
by monitoring patient while inpatient
Number of dialysis treatments
by monitoring patients health at each visit, and notification of hospitalizations/AE's
Number of biopsies
medical record review of clinically indicated renal allograft biopsies performed within the followup 12 month period
Biopsy proven acute rejection events
by blood draws, and by monitoring patients health at each visit, and notification of hospitalizations/AE's
Patient and graft survival
by monitoring patients health at each visit, and notification of hospitalizations/AE's
Number of hospital readmissions
by monitoring patients health at each visit, and notification of hospitalizations/AE's
Detection of DSA (Luminex)
by blood draw
Incidence and type of infection
by monitoring patients health at each visit, and notification of hospitalizations/AE's
Measured or estimated creatinine clearance.
by blood draw
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
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
Full Information
NCT ID
NCT02134288
First Posted
April 21, 2014
Last Updated
September 17, 2021
Sponsor
Ohio State University
Collaborators
Bristol-Myers Squibb
1. Study Identification
Unique Protocol Identification Number
NCT02134288
Brief Title
Belatacept for Renal Transplant Recipients With Delayed Graft Function
Official Title
Prospective, Randomized Trial of Belatacept Switch in Renal Transplant Recipients With Delayed Graft Function
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Terminated
Why Stopped
Drug unavailability due to a manufacturing transition.
Study Start Date
April 2014 (Actual)
Primary Completion Date
December 11, 2018 (Actual)
Study Completion Date
January 18, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ohio State University
Collaborators
Bristol-Myers Squibb
4. Oversight
Data Monitoring Committee
No
5. 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delayed Graft Function
Keywords
Dialysis, Kidney Transplant, immunosuppressive therapy, Delayed Graft Function, Belatacept
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Belatacept
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Everolimus
Arm Type
Active Comparator
Arm Description
Everolimus 1.5 mg/kg twice a day by mouth, the dose will be adjusted after Day 3.
Intervention Type
Drug
Intervention Name(s)
Belatacept
Other Intervention Name(s)
NULOJIX
Intervention Type
Drug
Intervention Name(s)
Everolimus
Other Intervention Name(s)
zortress
Primary Outcome Measure Information:
Title
Time to recover from Delayed Graft Function
Description
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).
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Percent patients reaching recovery (defined above) by 14 days and 3 months.
Description
Percent patients reaching recovery (defined above) by 14 days and 3 months.
Time Frame
Assessed at 3, 6, 12 months
Title
Hospital length of stay (days) from date of transplant to discharge
Description
by monitoring patient while inpatient
Time Frame
up to 7 days
Title
Number of dialysis treatments
Description
by monitoring patients health at each visit, and notification of hospitalizations/AE's
Time Frame
Assessed at 3, 6, 12 months
Title
Number of biopsies
Description
medical record review of clinically indicated renal allograft biopsies performed within the followup 12 month period
Time Frame
Assessed at 3, 6, 12 months
Title
Biopsy proven acute rejection events
Description
by blood draws, and by monitoring patients health at each visit, and notification of hospitalizations/AE's
Time Frame
Assessed at 3, 6, 12 months
Title
Patient and graft survival
Description
by monitoring patients health at each visit, and notification of hospitalizations/AE's
Time Frame
Assessed at 3, 6, 12 months
Title
Number of hospital readmissions
Description
by monitoring patients health at each visit, and notification of hospitalizations/AE's
Time Frame
Assessed at 3, 6, 12 months
Title
Detection of DSA (Luminex)
Description
by blood draw
Time Frame
Assessed at 3, 6, 12 months
Title
Incidence and type of infection
Description
by monitoring patients health at each visit, and notification of hospitalizations/AE's
Time Frame
Assessed at 3, 6, 12 months
Title
Measured or estimated creatinine clearance.
Description
by blood draw
Time Frame
Assessed at 3, 6, 12 months
Title
Banff score of rejection episodes and immune suppression treatment/management of rejection
Description
by monitoring patients health at each visit, and notification of hospitalizations/AE's
Time Frame
Assessed at 3, 6, 12 months
Title
Immune suppression drug levels (everolimus or sirolimus, cyclosporine, or mycophenolate as clinically monitored).
Description
by blood draw, and by monitoring patients health at each visit, and notification of hospitalizations/AE's
Time Frame
Assessed at 3, 6, 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon Von Visger, M.D./Ph.D.
Organizational Affiliation
OSU Wexner Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State Universtiy Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Belatacept for Renal Transplant Recipients With Delayed Graft Function
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