Infection, Transplant;Failure,Kidney
Conditions
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.
Interventions
DRUGMycophenolate Mofetil
Body surface area-based dosing of mycophenolate
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Enrollment rate in a trial of BSA-based vs. fixed dosing of mycophenolate | 6 months | Assess the ratio of participants screened to enrolled into the study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of a trial of BSA-based vs. fixed dosing of mycophenolate | 6 months | Assess the rate of dropout from the study |
| Collect pilot data of efficacy in a trial of BSA-based vs. fixed dosing of mycophenolate | 6 months | Collect pilot data on number of overall hospitalizations |
Countries
United States
Outcome results
None listed