The aDOPT Trial (Dose Optimisation Prior to Transplant):In kidney transplantation, can pre-transplant blood levels of mycophenolic acid (MPA) help to optimise individual patient's post-transplant mycophenolate mofetil (MMF) dose to improve outcomes?

Phase 4

Completed

• Conditions: End-stage kidney disease; Kidney transplantation; Acute transplant rejection; Drug toxicity; Renal and Urogenital - Kidney disease; Inflammatory and Immune System - Other inflammatory or immune system disorders

• Registration Number: ACTRN12615000273583
• Lead Sponsor: Murdoch Children's Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-03-23
• Study Completion: 2017-10-26
• Last Update Posted: 18 October 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

Child and adult participants at or near end-stage kidney disease (ESKD), working up to renal transplantation.

Exclusion Criteria

-Renal transplant protocols not including mycophenolate mofetil
-Adult ESKD patients on the cadaveric waiting list deemed unlikely to receive a transplant offer within a 2 year window.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients in the TDM-controlled dose arm within therapeutic range in the early post-transplant period.<br>This will be based on the MPA exposure - the MPA AUC over 12 hours (MPA AUC12). Serum assays of MPA concentration from a dosing interval will be used to estimate the MPA AUC over 12 hours, using the log-linear trapezoidal rule.<br><br>A two-group chi-square test with a 0.050 two-sided significance level will have 80% power to detect the difference between a (standard dose) group proportion, p1, of 0.54 and a (individualized dose) group proportion, p2, of 0.790 when the sample size in each group is 55.[At day 3-5, and day 7-14, following renal transplant.]