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

Kidney Transplant Rejection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02974686
• Other study ID #: 201603167
• Secondary ID: CRAD001AUS209T
• Status: Terminated
• Phase: Phase 4
• Start date: November 2016
• Est. completion date: September 2019

Study information

• Verified date: August 2020
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: September 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Digestive System Diseases
• Gastrointestinal Diseases
• Gastrointestinal Disorder, Functional
• Kidney Transplant Rejection

Intervention

Drug:
• Everolimus

• Mycophenolic Acid

Locations

Country	Name	City	State
United States	Washington University	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastrointestinal Symptom Rating Scale	Trial was terminated with only 1 participant enrolled. No data is reported here to maintain patient confidentiality.	3 months
Secondary	Gastrointestinal Symptom Rating Scale	Trial was terminated with only 1 participant enrolled. No data is reported here to maintain patient confidentiality.	1, 6, and 12 months
Secondary	Biopsy Proven Acute Rejection	Trial was terminated with only 1 participant enrolled. No data is reported here to maintain patient confidentiality.	12 months