Status:
COMPLETED
Optima: Optimizing Prograf Therapy in Maintenance Allografts II
Lead Sponsor:
East Carolina University
Collaborating Sponsors:
Astellas Pharma US, Inc.
Conditions:
Kidney Transplantation
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
Brief Summary
This study is designed to optimize calcineurin immunosuppressive regimens and evaluate immunological and non-immunological markers that may explain mechanistic differences in these agents and their ef...
Detailed Description
One of the major challenges in transplantation over the past two decades has been managing long-term renal function. Serum creatinine is the most commonly used serum marker of renal function. However ...
Eligibility Criteria
Inclusion
- Patient is the recipient of a cadervic or living donor renal transplant.
- Patient was 18 years of age at time of transplant.
- Patient is at least 6 months post-transplant.
- Patient has been on a cyclosporine-based immunosuppressive regimen since the transplant.
- Patient has a functioning allograft and a Cockcroft/Gault estimate of creatinine clearance \>or= 35 mL/min within four weeks prior to randomization.
- Patient or legal guardian has signed and dated an Institutional Review Board (IRB) approved informed consent document and is willing and able to follow study procedures.
- Females are not pregnant and agree to practice effective birth control while receiving immunosuppressant medication.
Exclusion
- Patient is the recipient of a solid organ transplant other than the kidney.
- Patient experienced biopsy-confirmed, acute rejection, (Banff 97 criteria)within 3 months before randomization that required treatment, which is defined as antilymphocyte therapy, corticosteroids, or an increase in the number or dose of immunosuppressant medication.
- Patient has recurrence of primary renal disease, or de novo renal disease.
- Patient has a urine protein of \> 1.5g/24 hours or two successive urinalyses sent to and reported by the laboratory indicating albuminuria greater than 2+ within 6 months prior to enrollment.
- Patient has an estimated creatinine clearance \< 35 mL/min calculated using Cockcroft/Gault formula within four weeks prior to randomization.
- Patient has changed adjunctive immunosuppressant therapy within one month if randomization.
- Patient is pregnant or lactating.
- Patient is a known carrier of any of the HIV viruses.
- Patient has a known or suspected malignancy (except for treated squamous or basal cell skin cancers) \< 5 years before randomization or a history of post-transplant lymphoproliferative disease (PTLD).
- Patient has a known hypersensitivity to tacrolimus, or any of the excipients of the drug.
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT00905515
Start Date
August 1 2003
End Date
July 1 2008
Last Update
September 7 2023
Active Locations (1)
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1
Brody School of Medicine at East Carolina University
Greenville, North Carolina, United States, 27834