- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00905242
Impact of Myfortic on Gastrointestinal (GI) Prophylaxis in Maintenance Renal Transplant Patients (MPACT)
May 18, 2009 updated by: East Carolina University
Impact of Myfortic on GI Prophylaxis in Maintenance Renal Transplant Patients
The purpose of this study is to determine whether maintenance renal transplant patients receiving Myfortic can reduce or discontinue GI prophylaxis medications.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
61
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Carolina
-
Greenville, North Carolina, United States, 27834
- Brody School of Medicine at East Carolina University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
90 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To evaluate the cost effectiveness of discontinuing GI medications in transplant recipients.
Time Frame: 90 days
|
90 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2006
Primary Completion (Actual)
January 1, 2007
Study Completion (Actual)
January 1, 2007
Study Registration Dates
First Submitted
May 18, 2009
First Submitted That Met QC Criteria
May 18, 2009
First Posted (Estimate)
May 20, 2009
Study Record Updates
Last Update Posted (Estimate)
May 20, 2009
Last Update Submitted That Met QC Criteria
May 18, 2009
Last Verified
May 1, 2009
More Information
Terms related to this study
Other Study ID Numbers
- CERL080A-US41
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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