The Mycophenolate Pregnancy Registry

NCT01733082 · tracked via the Priya Life Science USA tracker

Sponsor

Genentech, Inc.

Phase

Observational

Started

2012-11-20

Last updated

2026-09-08

Condition(s) studied

Heart Transplantation, Kidney Transplantation, Liver Transplantation, Autoimmune Diseases

Study summary

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.

Eligibility

Sex

FEMALE

Min age

—

Max age

—

Healthy volunteers

Inclusion Criteria: * Pregnancy and reported maternal exposure to mycophenolate during pregnancy or within 6 weeks of discontinuing treatment Exclusion Criteria: * Pregnancies for which there is paternal exposure only * Pregnancies occurring outside the U.S.

Primary outcome measure(s)

Maternal Outcomes: Incidence of Pregnancy Complications — Approximately 13 years
Fetal Outcomes: Incidence of Congenital Disorders — Approximately 13 years
Time/Duration of Mycophenolate Exposure — Approximately 13 years
Mycophenolate Dose/Regimen — Approximately 13 years
Indications for Mycophenolate use — Approximately 13 years
Maternal Medical/Demographic Characteristics — Approximately 13 years

Trial sites (1)

Facility	City	Region	Status
Quintiles Outcome	Cambridge	Massachusetts	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT01733082 on ClinicalTrials.gov ↗ ← All trials in the USA