Standard Therapy or Individualized Immunosuppression For Lowering Adverse Event Risk

Infection Clinical Trial

— STIFLE-RISK  

Official title:

Standard Therapy or Individualized Immunosuppression For Lowering Adverse Event Risk

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04473924
• Other study ID #: 20-31500
• Status: Withdrawn
• Phase: Phase 2
• Start date: July 2022
• Est. completion date: May 2023

Study information

• Verified date: May 2022
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn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

Related Conditions & MeSH terms

• Infection
• Renal Insufficiency
• Transplant;Failure,Kidney

Intervention

Drug:
• Mycophenolate Mofetil
Body surface area-based dosing of mycophenolate
• Mycophenolate Mofetil
Standard (fixed) dosing of mycophenolate

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

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