NCT00905242

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

Impact of Myfortic on GI Prophylaxis in Maintenance Renal Transplant Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: East Carolina University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2006-03-01
• Primary completion: 2007-01-01
• Completion: 2007-01-01
• First posted: 2009-05-20
• Last updated: 2009-05-20

Locations

1 site across 1 country: United States