Standard Therapy or Individualized Immunosuppression For Lowering Adverse Event Risk (STIFLE-RISK)

University of California San Francisco (UCSF)

Status and phase

Withdrawn

Phase 2

Conditions

Infection

Transplant;Failure,Kidney

Treatments

Drug: Mycophenolate Mofetil

Study type

Interventional

Funder types

Other

Identifiers

NCT04473924

20-31500

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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