This study is not yet accepting patients

Standard Therapy or Individualized Immunosuppression For Lowering Adverse Event Risk

a study on Infection

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California
Dates
study started
estimated completion
Principal Investigator
Elaine Ku, MD
Photo of Elaine Ku
Elaine Ku

Description

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.

Keywords

Infection Transplant;Failure,Kidney Renal Insufficiency Mycophenolic Acid Mycophenolate Mofetil Body surface area-based mycophenolate dosing

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 CAN'T join 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

Location

  • University of California, San Francisco
    San Francisco California 94143 United States

Lead Scientist at UCSF

  • Elaine Ku, MD
    The global context of my research program focuses on understanding differences in the epidemiology, clinical management, and outcomes of children versus adults with kidney disease and the conduct of clinical trials to test interventions (such as blood pressure control) that will improve survival of patients with kidney disease.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT04473924
Phase
Phase 2
Study Type
Interventional
Last Updated