Infection Clinical Trial
— STIFLE-RISKOfficial title:
Standard Therapy or Individualized Immunosuppression For Lowering Adverse Event Risk
NCT number | NCT04473924 |
Other study ID # | 20-31500 |
Secondary ID | |
Status | Withdrawn |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | July 2022 |
Est. completion date | May 2023 |
Verified date | May 2022 |
Source | University of California, San Francisco |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | May 2023 |
Est. primary completion date | January 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of California, San Francisco | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Feasibility of a trial of BSA-based vs. fixed dosing of mycophenolate | Assess the rate of dropout from the study | 6 months | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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