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Mycophenolate Mofetil Pharmacokinetics in Systemic Sclerosis

NCT03678987 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 35

Last updated 2020-03-13

No results posted yet for this study

Summary

Drug of investigation: Mycophenolate mofetil (MMF), given orally as a tablet twice daily.

Dosage of drug: This study recruits patients who have been prescribed a steady dose of MMF in the range between 1000 and 3000 mg daily by their physician.

Design: This is an open-label PK study.

Disease studied: Systemic sclerosis (SSC, scleroderma).

Variables assessed: Estimated AUC0-12 for MMF. Gastrointestinal manifestations of SSc. Concomitant medication.

Study population:

Inclusion criteria: Diagnosis of SSC fulfilling the 2013 classification criteria for this disease. Participant should have been prescribed a stable dose of MMF tablets, taken twice daily, for at least 3 months prior to the study.

Exclusion criteria: Failure to comply with study protocol. Limited access to repeated venous puncture. Recipient of organ transplant. Pulmonary arterial hypertension.

Number of participants: The study aims at the inclusion of 35 subjects.

Primary objective: To investigate the PK of orally ingested MMF in SSC.

Secondary objectives:

1. To investigate how SSC manifested in the gastrointestinal (GI) tract may alter the PK of MMF.
2. To investigate how the PK of MMF in SSc is altered by medications often used in SSC, i.e. proton pump inhibitors (PPI), NSAID and calcium channel blockers.

Conditions

Interventions

DIAGNOSTIC_TEST

P-MPA concentration

We will calculate AUC\_0-12 of MPA based on 4 measurements of P-MPA

DRUG

mycophenolic acid

Patient will ingest mycophenolic acid as prescribed by their physician under the surveillance of an investigator.

Sponsors & Collaborators

  • Region Skane

    lead OTHER

Principal Investigators

  • Kristofer Andréasson, MD PhD · Region Skane

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-13
Primary Completion
2020-01-01
Completion
2020-02-01
FDA Drug
Yes

Countries

  • Sweden

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03678987 on ClinicalTrials.gov