The Mycophenolate Pregnancy Registry

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Transplantation, Kidney Transplantation, Liver Transplantation, Autoimmune Diseases

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
• Study Contact Backup: Name: Reference Study ID Number: ML22679 https://forpatients.roche.com/ No attachments to email below.; Phone Number: 888-662-6728 (U.S. and Canada); Email: global-roche-genentech-trials@gene.com

Study Locations

• United States
  • Massachusetts
    • Cambridge, Massachusetts, United States, 02139
      • Recruiting
      • Quintiles Outcome

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Pregnant Patients Exposed to Mycophenolate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
Occurrence of Educational Counseling on the Increased Risks of Birth Defects With Mycophenolate Therapy	Approximately 13 years

Collaborators and Investigators

• Sponsor: Genentech, Inc.
• Collaborators: Novartis Pharmaceuticals; Mylan Pharmaceuticals Inc; Sandoz; Teva Pharmaceuticals USA; Amneal Pharmaceuticals, LLC; VistaPharm, Inc.; Apotex Inc.; Accord Healthcare, Inc.; Alkem Laboratories Ltd; Lannett Company, Inc.; Azurity Pharmaceuticals; Ascend Laboratories, LLC; Amta labs Limited; Avet Lifesciences Limited; Biocon Pharma Limited; Concord Biotech Limited; Hetero Labs Limited, Unit-V; Hikma Pharmaceuticals USA Inc.; Hisun Pharmaceuticals; Jubilant Cadista Pharmaceuticals, Inc.; Meitheal Pharmaceuticals, Inc.; Rising Pharma Holdings, Inc.; RK Pharma Inc.; Strides Pharma, Inc; TWi Pharmaceuticals, Inc.; Wuxi Fortune Pharmaceutical Co., Ltd; Zydus Pharmaceuticals; Endo USA Inc., a Keenova Therapeutics Company
• Investigators: Study Director: Clinical Trials, Genentech, Inc.

Publications and helpful links

Helpful Links

• Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours.

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2012
• Primary Completion (Estimated): December 31, 2040
• Study Completion (Estimated): December 31, 2040

Study Registration Dates

• First Submitted: November 20, 2012
• First Submitted That Met QC Criteria: November 23, 2012
• First Posted (Estimated): November 26, 2012

Study Record Updates

• Last Update Posted (Actual): September 8, 2026
• Last Update Submitted That Met QC Criteria: September 4, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases
• Other Study ID Numbers: ML22679

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO