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Trial record 90 of 6709 for:    Recruiting, Not yet recruiting, Available Studies | Digestion

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02974686
Recruitment Status : Recruiting
First Posted : November 28, 2016
Last Update Posted : July 16, 2019
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Kidney Transplant Rejection Gastrointestinal Disorder, Functional Drug: Everolimus Drug: Mycophenolic Acid Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Conversion From MPA to Zortress (Everolimus) for GI Toxicity Post-renal Transplantation
Actual Study Start Date : November 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Active Comparator: Interventional (EVR)
Patients experiencing gastrointestinal adverse effects in the first year post transplant will be converted from mycophenolate to everolimus
Drug: Everolimus
Other Name: Zortress

Active Comparator: Prior Agent (MPA)
Patient will have baseline data collected while on MPA for comparison with EVR
Drug: Mycophenolic Acid
Other Names:
  • Cellcept
  • Myfortic

Primary Outcome Measures :
  1. Gastrointestinal Symptom Rating Scale [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Gastrointestinal Symptom Rating Scale [ Time Frame: 1, 6, 9, and 12 months ]
  2. Biopsy Proven Acute Rejection [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02974686

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Contact: Rowena Delos Santos, MD
Contact: Jennifer Hagopian, PharmD

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United States, Missouri
Washington University Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Rowena Delos Santos, MD    314-362-4547   
Principal Investigator: Rowena Delos Santos, MD         
Sub-Investigator: Timothy Horwedel, PharmD         
Sub-Investigator: Jennifer Hagopian, PharmD         
Sponsors and Collaborators
Washington University School of Medicine
Novartis Pharmaceuticals

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Responsible Party: Washington University School of Medicine Identifier: NCT02974686     History of Changes
Other Study ID Numbers: 201603167
CRAD001AUS209T ( Other Grant/Funding Number: Novartis Pharmaceuticals Company )
First Posted: November 28, 2016    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Digestive System Diseases
Gastrointestinal Diseases
Mycophenolic Acid
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antibiotics, Antitubercular
Antitubercular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action