RecruitingNot Applicable

The Mycophenolate Pregnancy Registry

United States500 participantsStarted 2012-11-20

Plain-language 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.

Who can participate

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Maternal Outcomes: Incidence of Pregnancy Complications

Timeframe: Approximately 13 years

Fetal Outcomes: Incidence of Congenital Disorders

Timeframe: Approximately 13 years

Time/Duration of Mycophenolate Exposure

Timeframe: Approximately 13 years

Mycophenolate Dose/Regimen

Timeframe: Approximately 13 years

Indications for Mycophenolate use

Timeframe: Approximately 13 years

Maternal Medical/Demographic Characteristics

Timeframe: Approximately 13 years

Trial details

NCT IDNCT01733082

SponsorGenentech, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2040-12-31

Contact for this trial

Reference Study ID Number: ML22679 https://forpatients.roche.com/

888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

View on ClinicalTrials.gov More Heart Transplantation, Kidney Transplantation, Liver Transplantation, Autoimmune Diseases trials

Plain-language summary

Who can participate

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Maternal Outcomes: Incidence of Pregnancy Complications

Timeframe: Approximately 13 years

Fetal Outcomes: Incidence of Congenital Disorders

Timeframe: Approximately 13 years

Time/Duration of Mycophenolate Exposure

Timeframe: Approximately 13 years

Mycophenolate Dose/Regimen

Timeframe: Approximately 13 years

Indications for Mycophenolate use

Timeframe: Approximately 13 years

Maternal Medical/Demographic Characteristics

Timeframe: Approximately 13 years