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

Primary Purpose

Kidney Transplant Rejection, Gastrointestinal Disorder, Functional

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Everolimus

Mycophenolic Acid

About this trial

This is an interventional treatment trial for Kidney Transplant Rejection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Washington University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Interventional (EVR)

Prior Agent (MPA)

Arm Description

Patients experiencing gastrointestinal adverse effects in the first year post transplant will be converted from mycophenolate to everolimus

Patient will have baseline data collected while on MPA for comparison with EVR

Outcomes

Primary Outcome Measures

Gastrointestinal Symptom Rating Scale

Trial was terminated with only 1 participant enrolled. No data is reported here to maintain patient confidentiality.

Secondary Outcome Measures

Gastrointestinal Symptom Rating Scale

Trial was terminated with only 1 participant enrolled. No data is reported here to maintain patient confidentiality.

Biopsy Proven Acute Rejection

Trial was terminated with only 1 participant enrolled. No data is reported here to maintain patient confidentiality.

Full Information

NCT ID

NCT02974686

First Posted

November 3, 2016

Last Updated

August 7, 2020

Sponsor

Washington University School of Medicine

Collaborators

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT02974686

Brief Title

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

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Terminated

Why Stopped

low recruitment

Study Start Date

November 2016 (Actual)

Primary Completion Date

September 2019 (Actual)

Study Completion Date

September 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Washington University School of Medicine

Collaborators

Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Kidney Transplant Rejection, Gastrointestinal Disorder, Functional

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Interventional (EVR)

Arm Type

Active Comparator

Arm Description

Patients experiencing gastrointestinal adverse effects in the first year post transplant will be converted from mycophenolate to everolimus

Arm Title

Prior Agent (MPA)

Arm Type

Active Comparator

Arm Description

Patient will have baseline data collected while on MPA for comparison with EVR

Intervention Type

Drug

Intervention Name(s)

Everolimus

Other Intervention Name(s)

Zortress

Intervention Type

Drug

Intervention Name(s)

Mycophenolic Acid

Other Intervention Name(s)

Cellcept, Myfortic

Primary Outcome Measure Information:

Title

Gastrointestinal Symptom Rating Scale

Description

Trial was terminated with only 1 participant enrolled. No data is reported here to maintain patient confidentiality.

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Gastrointestinal Symptom Rating Scale

Description

Trial was terminated with only 1 participant enrolled. No data is reported here to maintain patient confidentiality.

Time Frame

1, 6, and 12 months

Title

Biopsy Proven Acute Rejection

Description

Trial was terminated with only 1 participant enrolled. No data is reported here to maintain patient confidentiality.

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Washington University

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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