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

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

Study Overview

• Status: Completed
• Conditions: End Stage Renal Disease (ESRD)
• Intervention / Treatment: Drug: Mycophenolic Acid (Myfortic)

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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • University of Cincinnati
    • Cincinnati, Ohio, United States, 45267
      • The Christ Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: 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).; Other Names: mycophenolic acid enteric coated
Active Comparator: Mycophenolic Acid (Myfortic) Standard; Mycophenolic Acid (Myfortic) 720 mg twice daily (1440 mg/day).	Drug: 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).; Other Names: mycophenolic acid enteric coated

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of All Biopsy Proven Acute Rejection.	Treatment efficacy, defined as the incidence of all biopsy proven acute rejection. Biopsy was proven with tissue samples collected on patients with elevated serum creatinine	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient and Allograft Survival 12 Months	Patient and allograft survival at 12 months post-transplant. Allograft survival is different from rejection. An allograft can have rejection, but the allograft can still have survival. If an allograft fails and is no longer functioning this would be considered allograft failure and non-survival.	12 months
Renal Function at 12 Months	Renal function measured by serum creatinine (SCr) at 12 months post-transplant	12 months
Incidence of Post Transplant Infections	Incidence of post transplant infections that resulted in hospitalization	12 months
GI Toxicities	Hospitalizations due to Gastrointestinal (GI) toxicities of mycophenolic acid enteric coated (Myfortic)	12 months

Collaborators and Investigators

• Sponsor: University of Cincinnati
• Collaborators: Novartis

Study record dates

Study Major Dates

• Study Start: April 1, 2006
• Primary Completion (Actual): January 1, 2008
• Study Completion (Actual): January 1, 2008

Study Registration Dates

• First Submitted: September 8, 2006
• First Submitted That Met QC Criteria: September 8, 2006
• First Posted (Estimate): September 11, 2006

Study Record Updates

• Last Update Posted (Estimate): April 28, 2016
• Last Update Submitted That Met QC Criteria: March 28, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Corticosteroid; Transplant; Kidney; Myfortic
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antitubercular Agents; Antibiotics, Antitubercular; Mycophenolic Acid
• Other Study ID Numbers: MyforticINVINT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO