NCT02974686

Conversion From MPA to Zortress (Everolimus) for GI Toxicity Post-renal Transplantation

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients who receive renal transplantation at Barnes Jewish Hospital (BJH) are placed on triple maintenance immunosuppression, which means that patients take 3 types of immunosuppression drugs to suppress their immune system including tacrolimus, mycophenolate (MPA), and prednisone. However, due to the effects of MPA on the gastrointestinal tract, patients often complain of GI adverse effects. Current practice is to either dose-reduce MPA or convert the patient to an alternative agent, typically Azathioprine. Both of these strategies have limitations, largely due to concerns related to efficacy. Everolimus (EVR) has demonstrated similar efficacy to MPA in renal transplantation and may offer a benefit related to GI adverse effects, so the investigators will convert patients to EVR in this study. Patients who are within their first year post-transplant will be converted to EVR upon enrollment in the study, and serial measurements ,or a series of measurements looking for an increase or decrease over time, of GI adverse effects will be conducted over 1 year post-enrollment.

Conditions

• Kidney Transplant Rejection
• Gastrointestinal Disorder, Functional

Interventions

Type	Name	Description
DRUG	Everolimus
DRUG	Mycophenolic Acid

Timeline

• Start date: 2016-11-01
• Primary completion: 2019-09-01
• Completion: 2019-09-01
• First posted: 2016-11-28
• Last updated: 2020-08-10
• Results posted: 2020-08-10

Locations

1 site across 1 country: United States