Recruiting

Mycophenolate

Sponsor:

Genentech, Inc.

Code:

NCT01733082

Conditions

Heart Transplantation, Kidney Transplantation, Liver Transplantation, Autoimmune Diseases

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Heart Transplantation, Kidney Transplantation, Liver Transplantation, Autoimmune Diseases

Study ID

NCT01733082

Start date

Nov 20, 2012

Status verified date

Oct, 2026

Completion date

Dec 31, 2040

Anticipated

Primary completion date

Dec 31, 2040

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

Pregnant Patients Exposed to Mycophenolate

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Reference Study ID Number: ML22679 https://forpatients.roche.com/ No attachments to email below.

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

Locations

Quintiles Outcome

Recruiting

Cambridge, Massachusetts, United States, 02139

More Information

Sponsor

Genentech, Inc.

Last update posted

Oct 6, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-09. This information was provided to ClinicalTrials.gov by Genentech, Inc. on 2026-10-06. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.