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

University of California San Francisco (UCSF) logo

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Withdrawn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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

0 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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