- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02152345
Belatacept Compared to Tacrolimus in Deceased Donor Renal Transplant Recipients
A Randomized Clinical Trial of Efficacy and Safety on the Use of Belatacept as Compared to Tacrolimus in the Setting of Rabbit Antithymocyte Globulin Induction and Rapid Steroid Discontinuation in Deceased Donor Renal Transplant Recipients With a Focus on Ameliorating Delayed Graft Function
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10032
- Columbia University Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients must have known Epstein-Barr virus (EBV) serostatus, and that status must be positive
- Adult patients ≥18 years of age, receiving a deceased donor kidney transplant at Columbia University Medical Center (CUMC)
- Patients with a PRA ≤ of 50
- Primary or re-transplant candidates (no more than 5th renal transplant)
- Deceased donor renal transplant recipients
- Candidates eligible for rATG induction
- Patients fully consented prior to transplantation
- Women of reproductive age who are willing to delay pregnancy for the duration of the study and use appropriate recommended contraception
Exclusion Criteria:
- Seronegative or unknown EBV serologic status (due to the risk of post-transplant lymphoproliferative disorder, PTLD), predominantly involving the central nervous system.
- Patients with tuberculosis who have not been treated for latent infection.
- Scheduled to undergo multi-organ transplantation
- Recipients of previous non-renal organ transplant
- Patient receiving 5th renal transplant at the time of screening.
- Patients with a PRA > 50
- Recipient is pre-emptive status.
- Recipient with positive flow crossmatch.
- History or known HIV
- Known hypersensitivity or contra-indications to Belatacept, Tacrolimus, Mycophenolate mofetil (cellcept), or mycophenolic acid
- Use of an investigational drug in the past 30 days before day of surgery
- Enrolled in a clinical trial other than the current
- Lactating or pregnant women
- Donor specific antibodies (DSA) identified at the time of transplantation
- ABO incompatible renal transplant
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Belatacept Immunosuppression
Renal transplant recipients will receive steroids (Methylprednisolone), rATG, Belatacept and Mycophenolate.
Subjects will be followed for primary endpoint to Day 7 and Month 3 after transplantation and secondary endpoints of kidney function and patient and graft survival up to month 36 after transplantation.
|
Belatacept 10 mg/kg will be administered in the operating room approximately 1 hour prior to kidney allograft reperfusion (Day 0). It will then be administered at 10 mg/kg on the following post-transplantation days: Day 5, 14, 30, 56, and 84. Belatacept 5 mg/kg will be administered every four weeks thereafter until end of study.
Other Names:
An immunosuppressive agent used with other medicines to lower the body's natural immunity in patients who receive kidney transplants. 720 mg by mouth every 12 hours (Day 0)(1080 mg AA). (standard of care)
Other Names:
1.5 mg/kg IV daily on Day 0-3. (standard of care)
Other Names:
500 mg (Day 0), 250mg (Day 1), 125mg (Day 2), 75 mg (Day 3) IV administered from Day 0-3. (standard of care)
Other Names:
Standard organ transplant of a kidney into a patient with end-stage renal disease.
Other Names:
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ACTIVE_COMPARATOR: Standard Immunosuppression (Tacrolimus)
Renal transplant recipients will receive standard immunosuppressive therapy, including steroids (Methylprednisolone), rATG, Tacrolimus and Mycophenolate.
Subjects will be followed for primary endpoint to Day 7 and Month 3 after transplantation and secondary endpoints of kidney function and patient and graft survival up to month 36 after transplantation.
|
An immunosuppressive agent used with other medicines to lower the body's natural immunity in patients who receive kidney transplants. 720 mg by mouth every 12 hours (Day 0)(1080 mg AA). (standard of care)
Other Names:
1.5 mg/kg IV daily on Day 0-3. (standard of care)
Other Names:
500 mg (Day 0), 250mg (Day 1), 125mg (Day 2), 75 mg (Day 3) IV administered from Day 0-3. (standard of care)
Other Names:
Standard organ transplant of a kidney into a patient with end-stage renal disease.
Other Names:
Tacrolimus 0.05 mg/kg by mouth every 12 hours will be on Day 0 after transplantation. It will then be administered at 8-12 ng/mL on the following post-transplantation days: Day 3-90; at 8-10 ng/mL Day 91-180. Tacrolimus 6 - 8 ng/mL will be administered daily thereafter until end of study. (standard of care)
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Delayed Graft Function (DGF)
Time Frame: Up to 3 months post-transplantation
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To assess whether treatment with Thymoglobulin induction and belatacept based maintenance immunosuppression would reduce delayed graft function (DGF) rates among recipients of deceased donor renal transplants as measured by clinical findings and NGAL marker, as specified below and defined by others. This will be compared to the incidence of DGF in patients treated with a Tacrolimus based regimen. Patients who require hemodialysis in the first 7 days after transplantation and/or patients whose serum creatinine decreases <10% during 3 consecutive days after the transplant will be considered to have DGF in the absence of other confounding factors such as obstruction or infection. NGAL will be used as a verification marker of DGF. |
Up to 3 months post-transplantation
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Allograft Survival
Time Frame: Up to 1 year post-transplantation
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Allograft survival is defined as functioning renal transplant.
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Up to 1 year post-transplantation
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Number of Participants With an Allograft Rejection Episode
Time Frame: Up to 1 year post-transplantation
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All rejection episodes will be confirmed by renal transplant biopsy provoked by change in renal function not explained by other clinical causes.
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Up to 1 year post-transplantation
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Estimated Glomerular Filtration Rate (eGFR)
Time Frame: Up to 1 year post-transplantation
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Estimated glomerular filtration rate (eGFR) is based on a blood sample (serum creatinine value), age, race, and gender.
eGFR estimates best the function of the kidney at any one time.
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Up to 1 year post-transplantation
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mark A. Hardy, MD, Columbia University
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Delayed Graft Function
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Neuroprotective Agents
- Protective Agents
- Immune Checkpoint Inhibitors
- Calcineurin Inhibitors
- Methylprednisolone
- Tacrolimus
- Abatacept
- Thymoglobulin
- Antilymphocyte Serum
Other Study ID Numbers
- AAAL7011
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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