Clinical trial NCT02974686: Conversion From MPA to Zortress (Everolimus) for GI Toxicity Post-renal Transplantation
Official title: Conversion From MPA to Zortress (Everolimus) for GI Toxicity Post-renal Transplantation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Kidney Transplant Rejection
Gastrointestinal Disorder, Functional
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Novartis Pharmaceuticals
First posted: 2016-11-28
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Dual organ or kidney after another solid organ transplant
2. Presence of a preexisting significant GI condition that does not have a presumed causal relationship with MPA
3. Evidence of any GI disorder induced by an infection, underlying medical condition, or concomitant medication other than MPA
4. Estimated glomerular filtration rate (eGFR) \<40 ml/min at time of possible conversion
5. Proteinuria \>1 gram/day at time of possible conversion
6. 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
7. Wound healing issues at time of possible conversion (eg, wound dehiscence, wound infection, incisional hernia, lymphocele, seroma)
8. Elevated total cholesterol (\>350 mg/dL) and/or triglycerides (\>500 ng/dL) at time of possible conversion
9. Hypersensitivity to everolimus, sirolimus, or other rapamycin derivatives

Primary outcomes:
measure: Gastrointestinal Symptom Rating Scale
timeFrame: 3 months
Secondary outcomes:
measure: Gastrointestinal Symptom Rating Scale
timeFrame: 1, 6, and 12 months
measure: Biopsy Proven Acute Rejection
timeFrame: 12 months
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
Study officials:
References: