Standard Therapy or Individualized Immunosuppression For Lowering Adverse Event Risk

NCT04473924 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: 20-31500
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Infection; Transplant;Failure,Kidney

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Feasibility of a trial of BSA-based vs. fixed dosing of mycophenolate

  6 months

• Collect pilot data of efficacy in a trial of BSA-based vs. fixed dosing of mycophenolate

  6 months

• Collect pilot data of efficacy in a trial of BSA-based vs. fixed dosing of mycophenolate

  6 months

• Collect pilot data of efficacy in a trial of BSA-based vs. fixed dosing of mycophenolate

  6 months

Study Arms (2)

Body surface area-based mycophenolate dosing

EXPERIMENTAL

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

Drug: Mycophenolate Mofetil

Standard (fixed) dosing

ACTIVE COMPARATOR

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

Drug: Mycophenolate Mofetil

Interventions

Mycophenolate Mofetil DRUG

Body surface area-based dosing of mycophenolate

Also known as: Cellcept

Body surface area-based mycophenolate dosing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Infections

Interventions

Mycophenolic Acid

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids

Study Officials

• Elaine Ku, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2020
• First Posted: July 16, 2020
• Study Start: July 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: May 1, 2023
• Last Updated: May 6, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)