Standard Therapy or Individualized Immunosuppression For Lowering Adverse Event Risk

Study Overview
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Brief Summary
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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.

Official Title
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Standard Therapy or Individualized Immunosuppression For Lowering Adverse Event Risk

Conditions
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Infection, Transplant;Failure,Kidney

Intervention / Treatment
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* Drug: Mycophenolate Mofetil
* Drug: Mycophenolate Mofetil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Body surface area-based mycophenolate dosing<br>Intervention group will receive mycophenolate mofetil 750 mg/m^2/day divided into twice daily dosing. | Drug: Mycophenolate Mofetil<br>* Body surface area-based dosing of mycophenolate<br>* Other names: Cellcept;|
| Active Comparator: Standard (fixed) dosing<br>Active comparator group will receive standard fixed dosing of mycophenolate mofetil 1000 mg twice daily. | Drug: Mycophenolate Mofetil<br>* Standard (fixed) dosing of mycophenolate<br>* Other names: Cellcept;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Enrollment rate in a trial of BSA-based vs. fixed dosing of mycophenolate | Assess the ratio of participants screened to enrolled into the study | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of a trial of BSA-based vs. fixed dosing of mycophenolate | Assess the rate of dropout from the study | 6 months | 
| Collect pilot data of efficacy in a trial of BSA-based vs. fixed dosing of mycophenolate | Collect pilot data on number of overall hospitalizations | 6 months | 
| Collect pilot data of efficacy in a trial of BSA-based vs. fixed dosing of mycophenolate | Collect pilot data on infectious-related hospitalizations | 6 months | 
| Collect pilot data of efficacy in a trial of BSA-based vs. fixed dosing of mycophenolate | Collect pilot data on incidence of leukopenia | 6 months |