Mycophenolate Pregnancy Registry

This registry is observing how mycophenolate (CellCept, Myfortic, and generic versions) affects pregnancy outcomes. It's for women who have been exposed to mycophenolate during pregnancy or within 6 weeks before becoming pregnant. The goal is to understand the rate of pregnancy complications for mothers and birth defects in babies, and how long mothers were exposed to the medication. This is an ongoing registry, and it's part of a safety plan required by the FDA.

Study design
This is an observational registry, meaning researchers will collect information without giving any specific treatments. It aims to include 500 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for approximately 13 years to track maternal and fetal outcomes, and the duration of mycophenolate exposure.

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NCT01733082

The Mycophenolate Pregnancy Registry

Recruiting
Not specifiedAll AgesObservational
Genentech, Inc.
~500 participants
Updated 2026-08-10 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maternal Outcomes: Incidence of Pregnancy Complications
Measured over Approximately 13 years
+5 more outcomes measured
Heart Transplantation, Kidney Transplantation, Liver Transplantation, Autoimmune Diseases
1 sites across 1 states
Massachusetts1
  • Clinical Trials · STUDY_DIRECTOR · Genentech, Inc.
Reference Study ID Number: ML22679 https://forpatients.roche.com/ No attachments to email below.
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Eligibility criteria

Inclusion

Pregnancy and reported maternal exposure to mycophenolate during pregnancy or within 6 weeks of discontinuing treatment

Exclusion

Pregnancies for which there is paternal exposure only
Pregnancies occurring outside the U.S.
  • Maternal Outcomes: Incidence of Pregnancy ComplicationsApproximately 13 years
  • Fetal Outcomes: Incidence of Congenital DisordersApproximately 13 years
  • Time/Duration of Mycophenolate ExposureApproximately 13 years
  • Mycophenolate Dose/RegimenApproximately 13 years
  • Indications for Mycophenolate useApproximately 13 years
  • Maternal Medical/Demographic CharacteristicsApproximately 13 years