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Tacrolimus Withdrawal in Low Risk Kidney Transplant Recipients
NCT01517984Phase 2
Key facts
- Status
- Terminated
- Start
- Nov 2010
- Primary completion
- May 2015
- Countries
- 2
- Sponsor
- National Institute of Allergy and Infectious Diseases
- Modality
- RNA-Targeting Small Molecules
- Drugs
- tacrolimus
- Conditions
- kidney transplant rejection
01
Overview
Phase 2, randomised, open-label trial of tacrolimus in kidney transplant rejection (2 arms), sponsored by National Institute of Allergy and Infectious Diseases. Primary endpoint: Percentage of Participants With Incremental IF/A Scores >2. Started Nov 2010; status: terminated.
02
Design
2 arms- Study design
- RandomizedOpen-label
Tacrolimus (CNI) Withdrawal
Subjects randomized to slowly withdraw tacrolimus while continuing MMF and prednisone.
Standard Immunosuppressive Therapy
Subjects randomized to continue standard therapy with tacrolimus, MMF, and prednisone.
03
Who it enrols
Primary living-donor kidney transplant recipients without history of acute rejection episodes or donor specific antibodies, receiving standard induction and maintenance immunosuppression.
04
Endpoints
Primary
Percentage of Participants With Incremental IF/A Scores >2
Secondary
Estimated GFR Using the Chronic Kidney Disease Epidemiology (CKD-EPI) Equation
Incidence of Acute Rejection
Allograft Survival Rate
Participant Survival Rate
Percentage of Participants With New Donor Specific Antibodies (DSAs)
Percentage of Participants With Donor-Specific Memory Using Elispot
Percentage of Participants in the Experimental Arm Off Tacrolimus
Incremental Change in IF/TA Scores
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