Myfortic or CellCept Gastrointestinal Effects in African American Kidney Recipients

NCT00522548 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: CERL080A-US49
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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, enteric coated mycophenolate sodium has been thought to possibly be associated with fewer gastrointestinal side effects. Mycophenolate mofetil and enteric coated mycophenolate sodium 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 enteric coated mycophenolate sodium and mycophenolate mofetil pharmacokinetics and gastrointestinal side effects in African American kidney transplant recipients.

Conditions

Transplants and Implants

Keywords

African American; Kidney Transplant

Outcome Measures

Primary Outcomes (1)

• Gastrointestinal Toxicity Due to Enteric Coated Mycophenolate Sodium or Mycophenolate Mofetil or Its Generic Equivalent Formulation Manufactured by Sandoz

  At 24 weeks, we assessed the number of patients at this timepoint who required permanent dose decrease or discontinuation of either enteric coated mycophenolate sodium or mycophenolate mofetil or its generic equivalent formulation manufactured by Sandoz related to gastrointestinal toxicity.

  6 months

Secondary Outcomes (11)

• The Incidence of the Requirement of Full Dose Proton Pump Inhibitors in Patients on Enteric Coated Mycophenolate Sodium or Mycophenolate Mofetil or Its Generic Equivalent Manufactured by Sandoz

  6 months

• The Incidence of Intolerance (Defined as Transient Dose Reduction or Transient Discontinuation of Enteric Coated Mycophenolate Sodium or Mycophenolate Mofetil or Its Generic Equivalent Manufactured by Sandoz

  6 months

• Gastrointestinal Symptom Rating Scale (GSRS) Score Changes From Baseline to 24 Weeks After Transplant in Patients on Enteric Coated Mycophenolate Sodium or Mycophenolate Mofetil or Its Generic Equivalent Manufactured by Sandoz

  baseline (pre-transplant to two days after transplant) and at 6 months after transplant.

• The Incidence of the Occurrence of Upper Gastrointestinal Symptoms Per GSRS Scale Ratings in Patients on Enteric Coated Mycophenolate Sodium or Mycophenolate Mofetil or Its Generic Equivalent Formulation Manufactured by Sandoz

  6 months

• The Incidence of the Occurrence of Lower Gastrointestinal Symptoms Per GSRS Scale Ratings in Patients on Enteric Coated Mycophenolate Sodium or Mycophenolate Mofetil or Its Generic Equivalent Manufactured by Sandoz

  6 months

Study Arms (2)

Enteric coated mycophenolate sodium

ACTIVE COMPARATOR

Patients in this group will receive Myfortic (enteric-coated mycophenolate sodium) at a target dose of 720 mg orally twice daily for 6 months after transplant.

Drug: Enteric coated mycophenolate sodium

Mycophenolate mofetil

ACTIVE COMPARATOR

Patients in this group will receive CellCept (mycophenolate mofetil) or its generic equivalent manufactured by Sandoz, at a target dose of 1000 mg orally twice daily for 6 months after transplant.

Drug: Mycophenolate mofetil

Interventions

Enteric coated mycophenolate sodium DRUG

Patients in this group will receive Myfortic (enteric-coated mycophenolate sodium) in combination with Thymoglobulin (rabbit Anti-thymocyte globulin) induction immunosuppression, Prograf (tacrolimus) or its generic equivalent, and corticosteroid immunosuppression.

Also known as: Myfortic

Enteric coated mycophenolate sodium

Mycophenolate mofetil DRUG

Patients in this group will receive CellCept (mycophenolate mofetil) or its generic equivalent formulation manufactured by Sandoz, in combination with Thymoglobulin (rabbit Anti-thymocyte globulin) induction immunosuppression, Prograf (tacrolimus) or its generic equivalent, and corticosteroid immunosuppression.

Also known as: CellCept

Mycophenolate mofetil

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104-4322, United States

Location

MeSH Terms

Interventions

Mycophenolic Acid

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids

Limitations and Caveats

Limitations of our study include small sample size and patient drop out-though not significantly different between the MMF and EC-MPS groups and limited follow-up

Results Point of Contact

• Title: Roy Bloom, MD
• Organization: University of Pennsylvania

roy.bloom@uphs.upenn.edu

215-662-4643

Study Officials

• Roy Bloom, MD

  University of Pennsylvania-Renal Electrolyte and Hypertension Division

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Masking description is not applicable since no masking was used in this study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director, Penn Kidney/Pancreas Transplant Program

Model Details: This study consisted of 2 parallel active comparator arms.

Study Record Dates

• First Submitted: August 27, 2007
• First Posted: August 29, 2007
• Study Start: March 1, 2007
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: January 23, 2018
• Results First Posted: January 23, 2018

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)