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

End Stage Renal Disease (ESRD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00374803
• Other study ID #: MyforticINVINT
• Status: Completed
• Phase: Phase 4
• First received: September 8, 2006
• Last updated: April 10, 2012
• Start date: April 2006
• Est. completion date: January 2008

Study information

• Verified date: April 2012
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 HLA-identical living donor.

• Recipient or donor is known to be seropositive for HCV, HBV, or 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, 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• End Stage Renal Disease (ESRD)
• Kidney Failure, Chronic

Intervention

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).

Locations

Country	Name	City	State
United States	The Christ Hospital	Cincinnati	Ohio
United States	University of Cincinnati	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University of Cincinnati	Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Patient and Graft Survival at 12 Months	Patient and graft survival at 12 months	12 months	Yes
Secondary	Renal Function at 12 Months	Renal function at 12 months	12 months	Yes
Secondary	Incidence of PTDM, Post Transplant Infections	Incidence of PTDM, post transplant infections	12 months	Yes
Secondary	Pharmacokinetic and Pharmacodynamic Profile	Pharmacokinetic and pharmacodynamic profile	12 months	No