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

Phase 4

Terminated

Conditions: Kidney Transplant Rejection
Gastrointestinal Disorder, Functional

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

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

Exclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Prior Agent (MPA)	Mycophenolic Acid	Patient will have baseline data collected while on MPA for comparison with EVR
Interventional (EVR)	Everolimus	Patients experiencing gastrointestinal adverse effects in the first year post transplant will be converted from mycophenolate to everolimus

Primary Outcome Measures

Name	Time	Method
Gastrointestinal Symptom Rating Scale	3 months	Trial was terminated with only 1 participant enrolled. No data is reported here to maintain patient confidentiality.

Secondary Outcome Measures

Name	Time	Method
Gastrointestinal Symptom Rating Scale	1, 6, and 12 months	Trial was terminated with only 1 participant enrolled. No data is reported here to maintain patient confidentiality.
Biopsy Proven Acute Rejection	12 months	Trial was terminated with only 1 participant enrolled. No data is reported here to maintain patient confidentiality.