Impact of Myfortic on Gastrointestinal (GI) Prophylaxis in Maintenance Renal Transplant Patients (MPACT)

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by:
East Carolina University
ClinicalTrials.gov Identifier:
NCT00905242
First received: May 18, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted
  Purpose

The purpose of this study is to determine whether maintenance renal transplant patients receiving Myfortic can reduce or discontinue GI prophylaxis medications.


Condition Intervention Phase
Kidney Transplantation
Drug: GI medication
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Impact of Myfortic on GI Prophylaxis in Maintenance Renal Transplant Patients

Resource links provided by NLM:


Further study details as provided by East Carolina University:

Primary Outcome Measures:
  • To determine the success (% of patients) in discontinuing GI medications over the 90-day period or also, % of patients able to maintain reduced doses of GI medications over the 90-day period. [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the cost effectiveness of discontinuing GI medications in transplant recipients. [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Enrollment: 61
Study Start Date: March 2006
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: GI medication
    Patients on daily dosing were asked to discontinue their GI medication at baseline. Patients on twice daily dosing were asked to reduce GI medication to once a day at baseline and asked to discontinue GI medication at day 30.
Detailed Description:

GI prophylaxis is common post kidney transplant and is routinely used in patients receiving a variety of different immunosuppressive regimens. Cellcept and prednisone are often the biggest concern for GI distress and GI ulcers. Routine use of GI prophylaxis medications post-transplant are potentially one mental obstacle to transplant clinicians being fully persuaded of the GI neutral effect of myfortic in the immunosuppressive regimen. Patients receiving myfortic (as part of the conversion in the US02 study) are theoretically at a reduced risk for GI upset and development of GI ulcers. These patients are ideal candidates to discontinue their GI prophylaxis medications while taking myfortic.

  Eligibility

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

Inclusion Criteria:

  • Patients who have completed the parent study, US02.
  • Patients on GI medications.
  • Patients currently receiving Myfortic (all dosages are allowed), neoral or tacrolimus with or without corticosteroids as part of their immunosuppressive regimen for at least two weeks.
  • Patients with and/or without mild GI complaints (e.g. upper abdominal pain, dyspepsia, anorexia, nausea, vomiting) with or without diarrhea.
  • Females of childbearing potential must have a negative pregnancy test prior to the inclusion period. The test should be performed at Baseline visit. If positive, the patient will not be included. Effective contraception must be used during the trial, and for 4 weeks following discontinuation of the study medication.
  • Patients who are willing and able to participate in the full course of the study and from whom written informed consent has been obtained.

Exclusion Criteria:

  • Evidence of graft rejection or treatment of acute rejection within 14 days prior to Baseline visit.
  • Patients who have received an investigational immunosuppressive drug within 4 weeks prior to study entry.
  • Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception.
  • Patients with thrombocytopenia (<75,000/mm3), with an absolute neutrophil count of <1,500/mm3 and/or leukocytopenia (<4,000/mm3), and/or hemoglobin <9.0g/dL prior to enrollment.
  • Presence of clinically significant infection requiring continued therapy, severe diarrhea or active peptic ulcer disease that would interfere with the appropriate conduct of the study.
  • Evidence of severe liver disease (incl. abnormal liver profile i.e. AST, ALT or total bilirubin >or= 3 times ULN).
  • Abnormal physical or laboratory findings of clinical significance within 2 weeks of inclusion which would interfere with the objectives of the study.
  • Evidence of drug and/or alcohol abuse.
  • Inability to self-administer the GSRS, GIQLI and PGWBI questionnaires.
  • Patients receiving >10mg/day prednisone dose.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00905242

Locations
United States, North Carolina
Brody School of Medicine at East Carolina University
Greenville, North Carolina, United States, 27834
Sponsors and Collaborators
East Carolina University
Novartis
Investigators
Principal Investigator: Paul Bolin, MD East Carolina University
  More Information

No publications provided

Responsible Party: Paul Bolin, MD, East Carolina University
ClinicalTrials.gov Identifier: NCT00905242     History of Changes
Other Study ID Numbers: CERL080A-US41
Study First Received: May 18, 2009
Last Updated: May 18, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by East Carolina University:
Kidney Transplantation
Gastrointestinal Agents

Additional relevant MeSH terms:
Gastrointestinal Agents
Mycophenolate mofetil
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 22, 2014