Loading clinical trials...

Study of Myfortic in Combination With Tacrolimus and Thymoglobulin in Early Corticosteroid Withdrawal | Clinical Trials | Clareo Health

COMPLETEDPHASE4

Study of Myfortic in Combination With Tacrolimus and Thymoglobulin in Early Corticosteroid Withdrawal

A 12-month, Prospective, Randomized, Single Center, Open Label Pilot Study to Evaluate the Safety and Efficacy of Myfortic in Combination With Tacrolimus and Thymoglobulin in Early Corticosteroid Withdrawal

NCT00374803•University of Cincinnati

View on ClinicalTrials.gov

Summary

To determine the safety and efficacy of a new formulation of Myfortic in combination with tacrolimus and thymoglobulin.

Detailed Description

Evaluate the safety and efficacy of Myfortic in combination with tacrolimus and anti-thymocyte globulin in an early corticosteroid withdrawal protocol. Secondary objective is to determine the pharmacokinetic-pharmacodynamic profile of Myfortic in a corticosteroid withdrawal protocol.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Males and females between 18 and 75 years of age.
•Patients who are primary or repeat cadaveric, living unrelated or non-HLA identical living related donor renal transplant recipients.

Exclusion Criteria

•Patient previously received or is receiving an organ transplant other than kidney.
•Primary or re-transplant from human leukocyte antigen (HLA)-identical living donor.
•Recipient or donor is known to be seropositive for hepatitis C virus (HCV), hepatitis B virus (HBV), or human immunodeficiency virus (HIV).
•Uncontrolled concomitant infection or other unstable medical condition.
•Patients that received an investigational drug in the 30 days prior to transplant.
•Known hypersensitivity to tacrolimus, mycophenolate mofetil (MMF), enteric-coated mycophenolic acid, rabbit anti-thymocyte globulin, or corticosteroids.
•Receiving chronic steroid therapy at the time of transplant.
•History of malignancy in last 5 years.
•Pregnant or lactating.

Locations (2)

The Christ Hospital

Cincinnati, Ohio, United States

University of Cincinnati

Cincinnati, Ohio, United States

Key Dates

Start Date

April 1, 2006

Primary Completion Date

January 1, 2008

Completion Date

January 1, 2008

Last Updated

April 28, 2016

Enrollment

ACTUAL participants

Conditions

End Stage Renal Disease (ESRD)

Interventions

Mycophenolic Acid (Myfortic)

DRUG

EndoForce Post Approval Study

NCT07146854

End Stage Renal Disease (ESRD)

View study

ENROLLING_BY_INVITATION

Dialysis Efficiency and Transporter Evaluation Computational Tool in Peritoneal Dialysis

NCT06842927

End-Stage Kidney DiseaseEnd Stage Renal Disease (ESRD)+4 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: April 28, 2016Data 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

Study of Myfortic in Combination With Tacrolimus and Thymoglobulin in Early Corticosteroid Withdrawal

Inclusion Criteria

Exclusion Criteria

EndoForce Post Approval Study

Dialysis Efficiency and Transporter Evaluation Computational Tool in Peritoneal Dialysis

A Study of Pharmacokinetics and Safety of LY3537031 in Participants With Normal Renal Function and Participants With Renal Impairment

Effect of Medium Cut-Off Hemodialysis on Protein Energy Wasting: The EMCOPEW Study

Comparison of Standard Versus High Dose Urokinase for Dysfunctional Tunneled Dialysis Catheters in Haemodialysis Patients: a Randomized Controlled Trial

Ultrasound Prediction of Successful Balloon Assisted AVF Maturation