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Standard Therapy or Individualized Immunosuppression For Lowering Adverse Event Risk (STIFLE-RISK)

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ClinicalTrials.gov Identifier: NCT04473924
Recruitment Status : Not yet recruiting
First Posted : July 16, 2020
Last Update Posted : July 16, 2020
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
Infections are common and associated with poor outcomes as well as high financial costs after kidney transplantation. Identifying and implementing strategies to reduce infections after kidney transplantation is important for improving patient outcomes. This study seeks to determine the feasibility of body surface area-based dosing of mycophenolate compared to standard dosing of mycophenolate in a pilot randomized controlled trial.

Condition or disease Intervention/treatment Phase
Infection Transplant;Failure,Kidney Drug: Mycophenolate Mofetil Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Standard Therapy or Individualized Immunosuppression For Lowering Adverse Event Risk
Estimated Study Start Date : February 1, 2022
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : May 1, 2023


Arm Intervention/treatment
Experimental: Body surface area-based mycophenolate dosing
Intervention group will receive mycophenolate mofetil 750 mg/m^2/day divided into twice daily dosing.
Drug: Mycophenolate Mofetil
Body surface area-based dosing of mycophenolate
Other Name: Cellcept

Active Comparator: Standard (fixed) dosing
Active comparator group will receive standard fixed dosing of mycophenolate mofetil 1000 mg twice daily.
Drug: Mycophenolate Mofetil
Standard (fixed) dosing of mycophenolate
Other Name: Cellcept




Primary Outcome Measures :
  1. Enrollment rate in a trial of BSA-based vs. fixed dosing of mycophenolate [ Time Frame: 6 months ]
    Assess the ratio of participants screened to enrolled into the study


Secondary Outcome Measures :
  1. Feasibility of a trial of BSA-based vs. fixed dosing of mycophenolate [ Time Frame: 6 months ]
    Assess the rate of dropout from the study

  2. Collect pilot data of efficacy in a trial of BSA-based vs. fixed dosing of mycophenolate [ Time Frame: 6 months ]
    Collect pilot data on number of overall hospitalizations

  3. Collect pilot data of efficacy in a trial of BSA-based vs. fixed dosing of mycophenolate [ Time Frame: 6 months ]
    Collect pilot data on infectious-related hospitalizations

  4. Collect pilot data of efficacy in a trial of BSA-based vs. fixed dosing of mycophenolate [ Time Frame: 6 months ]
    Collect pilot data on incidence of leukopenia



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

Inclusion Criteria:

  • Adult transplant recipients ≥18 years of age who have a functional allograft and have undergone kidney transplantation between six months and two years prior to study enrollment
  • Receiving mycophenolate mofetil for maintenance transplant immunosuppression at the time of the screening visit

Exclusion Criteria:

  • Evidence of rejection on routine six month post-transplant biopsy
  • Prior intolerance to mycophenolate mofetil necessitating drug discontinuation
  • Are or are planning to become pregnant, due to inability to take mycophenolate
  • Are marginally housed, due to concerns regarding routine follow-up
  • Are actively participating in a different interventional trial that may affect immunosuppression dosing
  • Are unwilling to consent to participate
  • Institutionalized individuals or prisoners
  • Are actively abusing illicit drugs or alcohol
  • Have a history of poor or doubtful compliance (e.g., frequently missed appointments)
  • Have cognitive impairment prohibiting participation in the study

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 ClinicalTrials.gov identifier (NCT number): NCT04473924


Contacts
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Contact: Elaine Ku, MD 415-353-2507 Elaine.Ku@ucsf.edu
Contact: Alex Dinh, MD Alex.Dinh@ucsf.edu

Locations
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United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Contact: Alex Dinh, MD       alex.dinh@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Elaine Ku, MD University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04473924    
Other Study ID Numbers: 20-31500
First Posted: July 16, 2020    Key Record Dates
Last Update Posted: July 16, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases
Mycophenolic Acid
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action