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Completed

NCT Number: NCT00374803

Study 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.

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Key information

Conditions

End Stage Renal Disease (ESRD) Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Christ Hospital, Cincinnati, Ohio, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mycophenolic Acid (Myfortic)

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).

Other names: mycophenolic acid enteric coated

Primary outcomes

  1. Incidence of All Biopsy Proven Acute Rejection.

    Time frame: 12 months

    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 outcomes

  1. Patient and Allograft Survival 12 Months

    Time frame: 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.

  2. Renal Function at 12 Months

    Time frame: 12 months

    Renal function measured by serum creatinine (SCr) at 12 months post-transplant

  3. Incidence of Post Transplant Infections

    Time frame: 12 months

    Incidence of post transplant infections that resulted in hospitalization

  4. GI Toxicities

    Time frame: 12 months

    Hospitalizations due to Gastrointestinal (GI) toxicities of mycophenolic acid enteric coated (Myfortic)

Sponsors and collaborators

Lead sponsor

University of Cincinnati

Other

Collaborators

  • Novartis

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Sep 11, 2006
Registry last updated
Apr 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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