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

Stopped early · Phase 4

Conditions studied: Kidney Transplant Rejection, Gastrointestinal Disorder, Functional

In brief

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.

Key facts

Study ID: NCT02974686
Run by: Washington University School of Medicine
People needed: 1
Starts: 2016-11-01
Expected to finish: 2019-09-01
Last updated by the study team: 2020-08-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Kidney transplant recipients at Washington University/Barnes-Jewish Hospital
Experiencing GI toxicity from MPA as determined by the treating physician within 12 months post-renal transplant
On standard immunosuppression with tacrolimus and prednisone

You may not qualify if…

Dual organ or kidney after another solid organ transplant
Presence of a preexisting significant GI condition that does not have a presumed causal relationship with MPA
Evidence of any GI disorder induced by an infection, underlying medical condition, or concomitant medication other than MPA
Estimated glomerular filtration rate (eGFR) <40 ml/min at time of possible conversion
Proteinuria >1 gram/day at time of possible conversion
Profound bone marrow suppression at the time of possible conversion as defined as:
Hemoglobin <10 g/dL
White blood cell (WBC) < 3 K/cumm
Platelets <100 K/cumm
Wound healing issues at time of possible conversion (eg, wound dehiscence, wound infection, incisional hernia, lymphocele, seroma)
Elevated total cholesterol (>350 mg/dL) and/or triglycerides (>500 ng/dL) at time of possible conversion
Hypersensitivity to everolimus, sirolimus, or other rapamycin derivatives

Where it is running

Washington University — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.