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

Sponsor
University of California, San Francisco (Other)
Overall Status
Withdrawn
CT.gov ID
NCT04473924
Collaborator
(none)
0
Enrollment
1
Location
2
Arms
10
Anticipated Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

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
  • Drug: Mycophenolate Mofetil
  • Drug: Mycophenolate Mofetil
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
0 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
Anticipated Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

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 Names:
  • 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 Names:
  • Cellcept

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Enrollment rate in a trial of BSA-based vs. fixed dosing of mycophenolate [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 [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 [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 [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 [6 months]

      Collect pilot data on incidence of leukopenia

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of California, San Francisco San Francisco California United States 94143

    Sponsors and Collaborators

    • University of California, San Francisco

    Investigators

    • Principal Investigator: Elaine Ku, MD, University of California, San Francisco

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of California, San Francisco
    ClinicalTrials.gov Identifier:
    NCT04473924
    Other Study ID Numbers:
    • 20-31500
    First Posted:
    Jul 16, 2020
    Last Update Posted:
    May 6, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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:
    Renal Insufficiency
    Mycophenolic Acid

    Study Results

    No Results Posted as of May 6, 2022