Phase 4
N=63
Optima: Optimizing Prograf Therapy in Maintenance Allografts II
Kidney Transplantation
Bottom Line
View on ClinicalTrials.gov: NCT00905515 ↗Enrolled (actual)
63
Serious AEs
4.8%
Results posted
Feb 2013
Primary outcome: Primary: Renal Function in Patients Converted From Cyclosporine to Prograf — 0.05; 0; 0.10 Change in serum creatinine (mg/dL)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- cyclosporine (Drug); Prograf (Tacrolimus) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- East Carolina University
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Renal Function in Patients Converted From Cyclosporine to Prograf |
0.05; 0; 0.10 | — |
| PRIMARY Optimal Dose of Calcineurin Inhibitor in Long-term Maintenance Kidney Transplant Patients |
130.2; 5.24; 6.90 | — |
| PRIMARY Change in Risk Factors for Cardiovascular Morbidity and Chronic Graft Dysfunction as Evidenced by Blood Levels of Homocysteine |
4.75; 4.72; 4.89 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00905515). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.