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

NCT ID: NCT00905242

Last Updated: 2009-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2007-01-31

Brief Summary

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

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.

Conditions

Kidney Transplantation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: collaborator

East Carolina University

OTHER

Sponsor Role: lead

Responsible Party

East Carolina University

Principal Investigators

Paul Bolin, MD

Role: PRINCIPAL_INVESTIGATOR

East Carolina University

Locations

Brody School of Medicine at East Carolina University

Greenville, North Carolina, United States

Countries

United States

Other Identifiers

CERL080A-US41

Identifier Type: -

Identifier Source: org_study_id