Standard Therapy or Individualized Immunosuppression For Lowering Adverse Event Risk

• Status: Not yet recruiting
• Trial end date: 2023-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Treatments: Mycophenolic Acid

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