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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00905242
First Posted: May 20, 2009
Last Update Posted: May 20, 2009
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.
Collaborator:
Novartis
Information provided by:
East Carolina University
  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: None (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 ]

Secondary Outcome Measures:
  • To evaluate the cost effectiveness of discontinuing GI medications in transplant recipients. [ Time Frame: 90 days ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): 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

Responsible Party: Paul Bolin, MD, East Carolina University
ClinicalTrials.gov Identifier: NCT00905242     History of Changes
Other Study ID Numbers: CERL080A-US41
First Submitted: May 18, 2009
First Posted: May 20, 2009
Last Update Posted: May 20, 2009
Last Verified: May 2009

Keywords provided by East Carolina University:
Kidney Transplantation
Gastrointestinal Agents

Additional relevant MeSH terms:
Mycophenolic Acid
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action