The Mycophenolate Pregnancy Registry

Recruiting now

Conditions studied: Heart Transplantation, Kidney Transplantation, Liver Transplantation, Autoimmune Diseases

In brief

The Mycophenolate Pregnancy Registry is designed as a prospective, observational registry collecting data regarding mycophenolate exposure during pregnancy, and pregnancy outcomes, fetal and infant outcomes after exposure. Early and later term pregnancy outcomes will be solicited at selected gestational time points. Structural and functional birth defects identified in the perinatal period through one year of life will be collected and classified. This is a non-proprietary registry and is a component of a comprehensive pregnancy Risk Evaluation and Mitigation Strategy (REMS) plan required by the FDA for all mycophenolate-formulations, including CellCept, Myfortic and any generic formulations.

Key facts

Study ID

NCT01733082

Run by

Genentech, Inc.

People needed

500

Starts

2012-11-20

Expected to finish

2040-12-31

Last updated by the study team

2026-07-10

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Pregnancies for which there is paternal exposure only
• Pregnancies occurring outside the U.S.

Where it is running

• Quintiles Outcome — Cambridge, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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