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

Primary Purpose

Infection, Transplant;Failure,Kidney

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Mycophenolate Mofetil
Mycophenolate Mofetil
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infection

Eligibility Criteria

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

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

Sites / Locations

  • University of California, San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Body surface area-based mycophenolate dosing

Standard (fixed) dosing

Arm Description

Intervention group will receive mycophenolate mofetil 750 mg/m^2/day divided into twice daily dosing.

Active comparator group will receive standard fixed dosing of mycophenolate mofetil 1000 mg twice daily.

Outcomes

Primary Outcome Measures

Enrollment rate in a trial of BSA-based vs. fixed dosing of mycophenolate
Assess the ratio of participants screened to enrolled into the study

Secondary Outcome Measures

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

Full Information

First Posted
July 13, 2020
Last Updated
May 2, 2022
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT04473924
Brief Title
Standard Therapy or Individualized Immunosuppression For Lowering Adverse Event Risk
Acronym
STIFLE-RISK
Official Title
Standard Therapy or Individualized Immunosuppression For Lowering Adverse Event Risk
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Study has never started as sponsor did not approve for funding.
Study Start Date
July 2022 (Anticipated)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection, Transplant;Failure,Kidney

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Body surface area-based mycophenolate dosing
Arm Type
Experimental
Arm Description
Intervention group will receive mycophenolate mofetil 750 mg/m^2/day divided into twice daily dosing.
Arm Title
Standard (fixed) dosing
Arm Type
Active Comparator
Arm Description
Active comparator group will receive standard fixed dosing of mycophenolate mofetil 1000 mg twice daily.
Intervention Type
Drug
Intervention Name(s)
Mycophenolate Mofetil
Other Intervention Name(s)
Cellcept
Intervention Description
Body surface area-based dosing of mycophenolate
Intervention Type
Drug
Intervention Name(s)
Mycophenolate Mofetil
Other Intervention Name(s)
Cellcept
Intervention Description
Standard (fixed) dosing of mycophenolate
Primary Outcome Measure Information:
Title
Enrollment rate in a trial of BSA-based vs. fixed dosing of mycophenolate
Description
Assess the ratio of participants screened to enrolled into the study
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Feasibility of a trial of BSA-based vs. fixed dosing of mycophenolate
Description
Assess the rate of dropout from the study
Time Frame
6 months
Title
Collect pilot data of efficacy in a trial of BSA-based vs. fixed dosing of mycophenolate
Description
Collect pilot data on number of overall hospitalizations
Time Frame
6 months
Title
Collect pilot data of efficacy in a trial of BSA-based vs. fixed dosing of mycophenolate
Description
Collect pilot data on infectious-related hospitalizations
Time Frame
6 months
Title
Collect pilot data of efficacy in a trial of BSA-based vs. fixed dosing of mycophenolate
Description
Collect pilot data on incidence of leukopenia
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elaine Ku, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Standard Therapy or Individualized Immunosuppression For Lowering Adverse Event Risk

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