Optima: Optimizing Prograf Therapy in Maintenance Allografts II (OPTIMAII)

September 5, 2023 updated by: Paul Bolin, East Carolina University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • Brody School of Medicine at East Carolina University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Group Cyclosporine
Maintain on Cyclosporine (CsA) at target trough level of 50-250 ng/mL.
Drug: cyclosporine
Maintain on cyclosporine at target trough level of 50-250 ng/mL.
Other Names:
  • Cyclosporine/Neoral®/Sandimmune®/Gengraf®
Active Comparator: Low Trough Level Prograf Group
Convert to Prograf (TAC) at target trough levels of 3.0-5.9 ng/mL.
Drug: Prograf (Tacrolimus)
Convert to Prograf at target trough levels of 3.0-5.9 ng/mL (Arm 2) or target trough levels of 6.0-8.9 ng/mL (Arm 3).
Other Names:
  • Tacrolimus/Prograf®/FK506
Active Comparator: High Trough Level Prograf Group
Convert to TAC at target trough levels of 6.0-8.9 ng/mL.
Drug: Prograf (Tacrolimus)
Convert to Prograf at target trough levels of 3.0-5.9 ng/mL (Arm 2) or target trough levels of 6.0-8.9 ng/mL (Arm 3).
Other Names:
  • Tacrolimus/Prograf®/FK506

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Renal Function in Patients Converted From Cyclosporine to Prograf
Time Frame: 3 years
3 years
Optimal Dose of Calcineurin Inhibitor in Long-term Maintenance Kidney Transplant Patients
Time Frame: 3 years
3 years
Change in Risk Factors for Cardiovascular Morbidity and Chronic Graft Dysfunction as Evidenced by Blood Levels of Homocysteine
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

East Carolina University

Collaborators

Astellas Pharma US, Inc.

Investigators

  • Principal Investigator: Paul Bolin, MD, East Carolina University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2003

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

May 18, 2009

First Submitted That Met QC Criteria

May 18, 2009

First Posted (Estimated)

May 20, 2009

Study Record Updates

Last Update Posted (Actual)

September 7, 2023

Last Update Submitted That Met QC Criteria

September 5, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MR-06-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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