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

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.

Study Overview

• Status: Withdrawn
• Conditions: Infection; Transplant;Failure,Kidney
• Intervention / Treatment: Drug: Mycophenolate Mofetil; Drug: Mycophenolate Mofetil

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California, San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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; Drug: Mycophenolate Mofetil; Standard (fixed) 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; Body surface area-based dosing of mycophenolate; Other Names: Cellcept; Drug: Mycophenolate Mofetil; Standard (fixed) dosing of mycophenolate; Other Names: Cellcept

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Enrollment rate in a trial of BSA-based vs. fixed dosing of mycophenolate	Assess the ratio of participants screened to enrolled into the study	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of a trial of BSA-based vs. fixed dosing of mycophenolate	Assess the rate of dropout from the study	6 months
Collect pilot data of efficacy in a trial of BSA-based vs. fixed dosing of mycophenolate	Collect pilot data on number of overall hospitalizations	6 months
Collect pilot data of efficacy in a trial of BSA-based vs. fixed dosing of mycophenolate	Collect pilot data on infectious-related hospitalizations	6 months
Collect pilot data of efficacy in a trial of BSA-based vs. fixed dosing of mycophenolate	Collect pilot data on incidence of leukopenia	6 months

Collaborators and Investigators

• Sponsor: University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 1, 2022
• Primary Completion (ANTICIPATED): January 1, 2023
• Study Completion (ANTICIPATED): May 1, 2023

Study Registration Dates

• First Submitted: July 13, 2020
• First Submitted That Met QC Criteria: July 13, 2020
• First Posted (ACTUAL): July 16, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 6, 2022
• Last Update Submitted That Met QC Criteria: May 2, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antitubercular Agents; Antibiotics, Antitubercular; Mycophenolic Acid
• Other Study ID Numbers: 20-31500

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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