NCT01733082

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2012

Completed
Same day until next milestone

Study Start

First participant enrolled

November 20, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 26, 2012

Completed
13.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 27, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 27, 2026

Completed
Last Updated

October 13, 2026

Status Verified

October 1, 2026

Enrollment Period

13.8 years

First QC Date

November 20, 2012

Last Update Submit

October 8, 2026

Conditions

Heart Transplantation, Kidney Transplantation, Liver Transplantation, Autoimmune Diseases

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (1)

  • Occurrence of Educational Counseling on the Increased Risks of Birth Defects With Mycophenolate Therapy

    Approximately 13 years

Study Arms (1)

Pregnant Patients Exposed to Mycophenolate

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Quintiles Outcome

Cambridge, Massachusetts, 02139, United States

Location

Related Links

MeSH Terms

Conditions

Autoimmune Diseases

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

  • Clinical Trials

    Genentech, Inc.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2012

First Posted

November 26, 2012

Study Start

November 20, 2012

Primary Completion

August 27, 2026

Study Completion

August 27, 2026

Last Updated

October 13, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)