Loading clinical trials...

A Study to Assess the Pharmacokinetics of a Modified-release Tacrolimus Based Immunosuppression Regimen in Stable Kidney Transplant Patients | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Study to Assess the Pharmacokinetics of a Modified-release Tacrolimus Based Immunosuppression Regimen in Stable Kidney Transplant Patients

A Phase 2, Open-Label, Multi-center Study to Assess the Pharmacokinetics, Safety and Tolerability of Tacrolimus in Stable Kidney Transplant Patients Converted From a Prograf® Based Immunosuppression Regimen to a Modified Release (MR) Tacrolimus Based Immunosuppression Regimen

NCT00282568•Astellas Pharma Inc

View on ClinicalTrials.gov

Summary

A study to assess the pharmacokinetics, safety and effectiveness of tacrolimus in stable kidney transplant patients converted from a Prograf® based immunosuppression regimen to a modified release tacrolimus based immunosuppression regimen.

Detailed Description

This is a Phase II open-label, multi-center conversion study in stable, adult kidney transplant recipients to assess the pharmacokinetics, safety and effectiveness of tacrolimus in stable kidney transplant patients converted from a Prograf® based immunosuppression regimen to a modified release tacrolimus based immunosuppression regimen.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patient is currently receiving Prograf ® based immunosuppressive therapy for kidney transplantation.
•Patient has stable whole blood trough level concentrations of Prograf® and is clinically stable

Exclusion Criteria

•Patient has previously received an organ transplant other than a kidney
•Patient is currently receiving sirolimus immunosuppression therapy.

Locations (9)

San Diego, California, United States

Miami, Florida, United States

Minneapolis, Minnesota, United States

Cincinnati, Ohio, United States

Portland, Oregon, United States

Madison, Wisconsin, United States

Milwaukee, Wisconsin, United States

Edmonton, Alberta, Canada

Toronto, Ontario, Canada

Key Dates

Start Date

August 1, 2002

Primary Completion Date

October 1, 2008

Completion Date

October 1, 2008

Last Updated

September 26, 2013

Enrollment

ACTUAL participants

Conditions

Kidney Transplantation

Interventions

Tacrolimus Modified Release (MR)

DRUG

tacrolimus

DRUG

Parathyroidectomy After Kidney Transplantation

NCT07415421

HyperparathyroidismKidney Transplantation Recipients

View study

RECRUITINGPHASE4

Strategic Help With Immunoglobulin to Enhance Protect Against Late Disease (CMV)

NCT06958796

CytomegalovirusOrgan Transplant+3 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 26, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study to Assess the Pharmacokinetics of a Modified-release Tacrolimus Based Immunosuppression Regimen in Stable Kidney Transplant Patients

Inclusion Criteria

Exclusion Criteria

Parathyroidectomy After Kidney Transplantation

Strategic Help With Immunoglobulin to Enhance Protect Against Late Disease (CMV)

Is Valacyclovir Non-inferior to Valganciclovir as CMV and EBV Prophylaxis in Kidney Transplant Recipients? A Single-Center Prospective Randomized Pilot Study

Study to Evaluate the Safety and Efficacy of the GGTA1 KO Thymokidney in Patients With ESRD

Tolerance Through Mixed Chimerism (Sip-Tego)

Study of the Link Between Complement Activation and IgA Nephropathy Severity