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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2008-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pharmacokinetics, Pharmacodynamics, and Safety Study of Ticagrelor in Hemodialysis Patients and Healthy Subjects

NCT02022748

Kidney Failure, Chronic

COMPLETED PHASE1

A Study to Investigate the Effect of Triferic Plus Heparin Infusion Compared to Heparin Alone on Coagulation Parameters in Hemodialysis Patients

NCT04042324

End Stage Renal Disease

COMPLETED PHASE1/PHASE2

Safety Study of CTA018 Injection to Treat Stage 5 Chronic Kidney Disease

NCT00742716

Chronic Kidney Disease Secondary Hyperparathyroidism Chronic Renal Insufficiency +1 more

COMPLETED PHASE2

A Clinical Study of MK-1084 in Participants With Renal Impairment (MK-1084-010)

NCT06814119

Healthy Renal Impairment

RECRUITING PHASE1

A Study Evaluating the Efficacy and Safety of Obinutuzumab in Participants With Primary Membranous Nephropathy

NCT04629248

Primary Membranous Nephropathy

ACTIVE_NOT_RECRUITING PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

End Stage Renal Disease (ESRD)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Mycophenolic Acid (Myfortic) Preload

Mycophenolic Acid (Myfortic) 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter

Group Type EXPERIMENTAL

Mycophenolic Acid (Myfortic)

Intervention Type DRUG

* Group 1: Mycophenolic Acid (Myfortic) 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter
* Group 2: Mycophenolic Acid (Myfortic) 720 mg twice daily (1440 mg/day).

Mycophenolic Acid (Myfortic) Standard

Mycophenolic Acid (Myfortic) 720 mg twice daily (1440 mg/day).

Group Type ACTIVE_COMPARATOR

Mycophenolic Acid (Myfortic)

Intervention Type DRUG

* Group 1: Mycophenolic Acid (Myfortic) 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter
* Group 2: Mycophenolic Acid (Myfortic) 720 mg twice daily (1440 mg/day).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mycophenolic Acid (Myfortic)

* Group 1: Mycophenolic Acid (Myfortic) 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter
* Group 2: Mycophenolic Acid (Myfortic) 720 mg twice daily (1440 mg/day).

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

mycophenolic acid enteric coated

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No