Optima: Optimizing Prograf Therapy in Maintenance Allografts II

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

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 effects.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: East Carolina University
• Collaborator: Astellas Pharma US, Inc.
• Treatments: Cyclosporine; Cyclosporins; Tacrolimus

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.