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

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Rita Alloway, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00374803
First received: September 8, 2006
Last updated: April 10, 2012
Last verified: April 2012
History of Changes
  Purpose

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


Condition Intervention Phase
End Stage Renal Disease (ESRD)
 Drug: Mycophenolic Acid (Myfortic)
 Phase 4

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • Incidence of All Biopsy Proven Acute Rejection. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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


Secondary Outcome Measures:
  • Patient and Graft Survival at 12 Months [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Patient and graft survival at 12 months

  • Renal Function at 12 Months [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Renal function at 12 months

  • Incidence of PTDM, Post Transplant Infections [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Incidence of PTDM, post transplant infections

  • Pharmacokinetic and Pharmacodynamic Profile [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Pharmacokinetic and pharmacodynamic profile


Enrollment: 45
Study Start Date: April 2006
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mycophenolic Acid (Myfortic) 1080mg BIDx14days, then 720mg BID
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).
Active Comparator: Mycophenolic Acid (Myfortic) 720 mg twice daily
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).

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00374803

Locations
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267
The Christ Hospital
Cincinnati, Ohio, United States, 45267
Sponsors and Collaborators
University of Cincinnati
Novartis
Investigators
Principal Investigator: Rita Alloway, PharmD University of Cincinnati
  More Information

No publications provided

Responsible Party: Rita Alloway, PharmD, FCCP, University of Cincinnati
ClinicalTrials.gov Identifier: NCT00374803     History of Changes
Other Study ID Numbers: MyforticINVINT
Study First Received: September 8, 2006
Results First Received: March 9, 2012
Last Updated: April 10, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Cincinnati:
Kidney
Transplant
Corticosteroid
Myfortic

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Mycophenolic Acid
Mycophenolate mofetil
Tacrolimus
Antibiotics, Antineoplastic
 Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 17, 2013