Standard Therapy or Individualized Immunosuppression For Lowering Adverse Event Risk

NCT ID: NCT04473924

Last Updated: 2022-05-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-31
• Study Completion Date: 2023-05-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Body surface area-based mycophenolate dosing

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

Group Type: EXPERIMENTAL

Mycophenolate Mofetil

Intervention Type: DRUG

Body surface area-based dosing of mycophenolate

Standard (fixed) dosing

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

Group Type: ACTIVE_COMPARATOR

Mycophenolate Mofetil

Intervention Type: DRUG

Standard (fixed) dosing of mycophenolate

Interventions

Mycophenolate Mofetil

Body surface area-based dosing of mycophenolate

Intervention Type: DRUG

Mycophenolate Mofetil

Standard (fixed) dosing of mycophenolate

Intervention Type: DRUG

Other Intervention Names

Cellcept; Cellcept

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elaine Ku, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California, San Francisco

San Francisco, California, United States

Countries

United States

Other Identifiers

20-31500

Identifier Type: -

Identifier Source: org_study_id