Population pharmacokinetics of mycophenolate mofetil in autoimmune diseases

Phase 4

Recruiting

• Conditions: autoimmune diseases; 10003816; 10029317; 10024967

• Registration Number: NL-OMON53229
• Lead Sponsor: Zuyderland Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

Mycophenolate mofetil use in autoimmune diseases

Exclusion Criteria

• age < 16 years
• Patient with serum levels of MPA not measured at steady state (<1 week of
doses-adjustment)
• Patients using the MPA preparation mycophenolic acid (Myfortic®)

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>MPA AUC0-12 determined on t=0, t=1 hour and t=3 hours. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Renal function, serum albumin levels, sex, ethnicity and concurrent<br /><br>administration of (possible) interacting drugs like proton-pump inhibitors,<br /><br>ciclosporin, antacids, colestyramin, sevelamer, rifampicin, telmisartan,<br /><br>metronidazole, ciprofloxacin, isavuconazonium and nintedanib.</p><br>