We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of Gastrointestinal Side Effects in African American Kidney Transplant Recipients Treated With CellCept or Myfortic

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00522548
Recruitment Status : Terminated (enrollment halted in order to have all patients complete follow-up by Jan 2011)
First Posted : August 29, 2007
Last Update Posted : February 21, 2011
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
Myfortic (enteric-coated mycophenolate sodium) has been shown to have similar effectiveness to CellCept (mycophenolate mofetil) in preventing rejection in kidney transplant recipients. However, Myfortic has been thought to possibly be associated with fewer gastrointestinal side effects. CellCept and Myfortic pharmacokinetics (how the drug is absorbed and broken down) have not been well-studied in African American kidney transplant recipients. The investigators are interested in studying Myfortic and CellCept pharmacokinetics and gastrointestinal side effects in African American kidney transplant recipients.

Condition or disease Intervention/treatment Phase
Kidney Transplantation Drug: Myfortic (enteric coated mycophenolate sodium) Drug: CellCept (Mycophenolate mofetil) Phase 4

Detailed Description:

African American patients often experience more gastrointestinal complications after kidney transplant than Caucasian patients. In addition, African American kidney transplant recipients also experience a higher incidence of acute rejection and have worse outcomes compared with all other ethnic groups. Reasons accounting for these differences are not well understood.

In light of the increased risk of GI complications in African American patients, we will compare in a pilot study, different regimens (described below) that we commonly use in our clinical practice in this population. As part of this study, patients will also fill out a GSRS survey at specified time points to help describe gastrointestinal side effects after transplant.

Pharmacokinetic studies (studies looking at how the drugs are absorbed and broken down) for Cellcept or Myfortic have largely been performed in Caucasian populations. There is little information available in African-American patients. This is particularly concerning in the face of the worst clinical outcomes observed after transplantation in African American kidney transplant recipients.

Comparisons: Patients will be randomized to one of two groups

  • Group 1: Myfortic (enteric-coated mycophenolate sodium) in combination with Prograf (tacrolimus) or its generic equivalent and corticosteroids
  • Group 2: CellCept (mycophenolate mofetil) or its generic equivalent in combination with Prograf (tacrolimus) or its generic equivalent and corticosteroids

Since toxicity of Cellcept and Myfortic may be influenced by pharmacokinetics (studies that look at how the drugs are absorbed and broken down) of these respective drugs, we will compare the pharmacokinetics of Myfortic and CellCept in a subset of patients. This pharmacokinetic data may have the additional valuable benefit of helping to optimize dosing parameters for Cellcept and Myfortic in African American kidney transplant patients in the future.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase IV Randomized, Open Label, Comparative, Single Center Study to Assess Gastrointestinal Adverse Effect Outcomes of De Novo African American Kidney Transplant Recipients Treated With Prograf (Tacrolimus) or Its Generic Equivalent/CellCept (Mycophenolate Mofetil) or Its Generic Equivalent/Corticosteroids Versus Prograf (Tacrolimus) or Its Generic Equivalent/Myfortic (Enteric Coated Mycophenolate Sodium)/Corticosteroids
Study Start Date : March 2007
Primary Completion Date : January 2011
Study Completion Date : January 2011


Arms and Interventions

Arm Intervention/treatment
Active Comparator: Myfortic Comparator Group
Patients in this group will receive Thymoglobulin (rabbit anti-thymocyte globulin) induction immunosuppression in combination with Myfortic (enteric-coated mycophenolate sodium), Prograf (tacrolimus) or its generic equivalent and corticosteroid immunosuppression
Drug: Myfortic (enteric coated mycophenolate sodium)
Patients in this group will receive Thymoglobulin (rabbit Anti-thymocyte globulin) induction immunosuppression, in combination with Myfortic (enteric-coated mycophenolate sodium, Prograf (tacrolimus) or its generic equivalent and corticosteroid immunosuppression.
Active Comparator: CellCept Comparator group
Patients in this group will receive Thymoglobulin (rabbit anti-thymocyte globulin) induction immunosuppression in combination with CellCept (mycophenolate mofetil) or its generic equivalent, Prograf (tacrolimus) or its generic equivalent and corticosteroid immunosuppression.
Drug: CellCept (Mycophenolate mofetil)
Patients in this group will receive Thymoglobulin (rabbit Anti-thymocyte globulin) induction immunosuppression, in combination with CellCept (mycophenolate mofetil) or its generic equivalent, Prograf (tacrolimus) or its generic equivalent and corticosteroid immunosuppression.


Outcome Measures

Primary Outcome Measures :
  1. Evaluate gastrointestinal toxicity defined as requirement of permanent dose decrease or discontinuation of Myfortic or CellCept related to gastrointestinal toxicity [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Evaluate the pharmacokinetics of CellCept or Myfortic in a sub-set of patients [ Time Frame: 6 months ]
  2. Evaluate the incidence of the requirement of full dose proton pump inhibitors [ Time Frame: 6 months ]
  3. Evaluate the incidence of intolerance (defined as transient dose reduction or transient discontinuation of Myfortic or CellCept therapy) [ Time Frame: 6 months ]
  4. Compare Gastrointestinal Symptom Rating Scale (GSRS) score changes from baseline to 24 weeks post-transplant [ Time Frame: 6 months ]
  5. Evaluate the incidence of the occurrence of upper and lower gastrointestinal symptoms (further details of definitions are provided by research center) [ Time Frame: 6 months ]
  6. Evaluate the incidence of rejection [ Time Frame: 6 months ]
  7. Compare changes from baseline serum creatinine and Modification of Diet and Renal Disease (MDRD) measured glomerular filtration rates to 24 weeks post-transplant [ Time Frame: 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Recipients of a deceased donor or living donor kidney transplant
  • Recipients of age greater than 18 years but less than 76 years
  • African Americans (self-reported patients of Black African descent who live in the United States)
  • Willingness to participate in a randomized, clinical trial, as indicated by signed informed consent
  • Patients with a history of gastrointestinal complications including any of the following: a history of diarrhea, constipation, acid reflux, or abdominal pain as reported by the patient
  • For women of childbearing age, effective contraception must be used before beginning CellCept or Myfortic, during therapy and 6 weeks after therapy has been discontinued (childbearing women should have a negative serum or urine pregnancy test within 1 week prior to starting CellCept or Myfortic therapy)

Exclusion Criteria:

  • Recipients with any prior solid organ transplant (including kidney)
  • Recipients receiving a concurrent solid organ (heart, liver, pancreas) or cell (islet, bone marrow, stem cell) transplant
  • Recipient age is less than 18 years old or greater than 75 years old
  • Recipients who are not African American (self-reported patients of Black African descent who live in the United States)
  • Recipients on proton pump inhibitor therapy at the time of initial screening (pre-transplant to 2 days post-transplant)
  • Recipients with a gastrointestinal bleed within the past three months
  • Recipients who are pregnant or breast feeding
  • Recipients with known human immunodeficiency virus (HIV) infection
  • Allergy to any of the immunosuppressant medications
  • Concurrent investigational medication
  • Any medical or psychosocial condition, which, in the opinion of the investigators, would hinder compliance with the study requirements
  • Inability or unwillingness of patient to provide informed consent
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00522548


Locations
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-4322
Sponsors and Collaborators
University of Pennsylvania
Novartis Pharmaceuticals
Investigators
Principal Investigator: Roy Bloom, MD University of Pennsylvania-Renal Electrolyte and Hypertension Division
More Information

Responsible Party: Roy Bloom, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00522548     History of Changes
Other Study ID Numbers: CERL080A-US49
First Posted: August 29, 2007    Key Record Dates
Last Update Posted: February 21, 2011
Last Verified: February 2011

Keywords provided by University of Pennsylvania:
African American
Kidney Transplant

Additional relevant MeSH terms:
Tacrolimus
Thymoglobulin
Antilymphocyte Serum
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents