Standard Therapy or Individualized Immunosuppression For Lowering Adverse Event Risk

Phase 2

Withdrawn

• Conditions: Infection; Transplant;Failure,Kidney
• Interventions: Drug: Mycophenolate Mofetil

• Registration Number: NCT04473924
• Lead Sponsor: University of California, San Francisco

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-13
• Study First Submitted QC: 2020-07-13
• Study First Posted: 2020-07-16
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-02
• Last Update Posted: 2022-05-06
• Study Start: 2022-07
• Primary Completion: 2023-01
• Study Completion: 2023-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Body surface area-based mycophenolate dosing	Mycophenolate Mofetil	Intervention group will receive mycophenolate mofetil 750 mg/m\^2/day divided into twice daily dosing.
Standard (fixed) dosing	Mycophenolate Mofetil	Active comparator group will receive standard fixed dosing of mycophenolate mofetil 1000 mg twice daily.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Feasibility of a trial of BSA-based vs. fixed dosing of mycophenolate	6 months	Assess the rate of dropout from the study
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

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States