Conversion From MPA to Zortress (Everolimus) for GI Toxicity Post-renal Transplantation
| Status: | Recruiting |
|---|---|
| Conditions: | Gastrointestinal, Digestive Disease |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/17/2018 |
| Start Date: | November 2016 |
| End Date: | December 2019 |
| Contact: | Rowena Delos Santos, MD |
| Email: | delossantos@wustl.edu |
Patients who receive renal transplantation at 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.
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.
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. 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
- 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 deriviatives
We found this trial at
1
site
Saint Louis, Missouri 63110
Principal Investigator: Rowena Delos Santos, MD
Phone: 314-362-4547
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