Completed

OPTIMAIIOptima: Optimizing Prograf Therapy in Maintenance Allografts II

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What is being tested

cyclosporine

+ Prograf (Tacrolimus)

Drug
Who is being recruted

From 18 to 85 Years
+17 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: August 2003
See protocol details

Summary

Principal SponsorEast Carolina University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2003

Actual date on which the first participant was enrolled.

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 serum creatinine is insensitive for detecting small decreases in glomerular filtration rate (GFR). Another marker for renal function is cystatin C. Dharnidharka et al concluded that cystatin C is superior to serum creatinine as a marker of kidney function since cystatin C was a more sensitive marker than serum creatinine for detecting decreases in GFR. Pirsch et al reported that tacrolimus-treated patients had a lower incidence of severe acute rejection and better lipid profiles than cyclosporine-treated patients. Cardiovascular disease is the primary cause of premature death in renal and other transplant recipients. Current immunosuppressive protocols often elevate cardiovascular disease risk factors such as hypertension, hyperlipidemia, obesity and diabetes. This study is designed to optimize calcineurin immunosuppressive regimens to ensure the best possible long-term outcomes after renal transplantation.

Official TitleOptima: Optimizing Prograf Therapy in Maintenance Allografts II
NCT00905515
Principal SponsorEast Carolina University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

63 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 85 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

7 inclusion criteria required to participate
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.

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10 exclusion criteria prevent from participating
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.

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Maintain on Cyclosporine (CsA) at target trough level of 50-250 ng/mL.

Group II

Active Comparator
Convert to TAC at target trough levels of 6.0-8.9 ng/mL.

Group III

Active Comparator
Convert to Prograf (TAC) at target trough levels of 3.0-5.9 ng/mL.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Brody School of Medicine at East Carolina University

Greenville, United StatesOpen Brody School of Medicine at East Carolina University in Google Maps
CompletedOne Study Center