Heart Transplantation, Kidney Transplantation, Liver Transplantation, Autoimmune DiseasesNCT01733082
The Mycophenolate Pregnancy Registry
An observational study of Heart Transplantation, Kidney Transplantation, Liver Transplantation, Autoimmune Diseases, run by Genentech, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Heart Transplantation, Kidney Transplantation, Liver Transplantation, Autoimmune Diseases
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2012to 27 Aug 2026
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Pregnancy and reported exposure to mycophenolate during pregnancy or within 6 weeks of discontinuing treatment
Who may be able to join
- Pregnancy and reported maternal exposure to mycophenolate during pregnancy or within 6 weeks of discontinuing treatment
Who cannot join
- Pregnancies for which there is paternal exposure only
- Pregnancies occurring outside the U.S.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Medical subject headings
- Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant Patients Exposed to Mycophenolate | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal Outcomes: Incidence of Pregnancy Complications
Measured: Approximately 13 years
Fetal Outcomes: Incidence of Congenital Disorders
Measured: Approximately 13 years
Time/Duration of Mycophenolate Exposure
Measured: Approximately 13 years
Mycophenolate Dose/Regimen
Measured: Approximately 13 years
Indications for Mycophenolate use
Measured: Approximately 13 years
Maternal Medical/Demographic Characteristics
Measured: Approximately 13 years
Secondary outcomes (1)
Occurrence of Educational Counseling on the Increased Risks of Birth Defects With Mycophenolate Therapy
Measured: Approximately 13 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2012 (estimated)
- Study start20 Nov 2012
- Primary completion27 Aug 2026
- Study completion27 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Transplantation, Kidney Transplantation, Liver Transplantation, Autoimmune DiseasesStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Accord Healthcare, Inc., Alkem Laboratories Ltd, Ascend Laboratories, LLC, Amneal Pharmaceuticals, LLC, Amta labs Limited, Apotex Inc., Avet Lifesciences Limited, Azurity Pharmaceuticals, Biocon Pharma Limited, Concord Biotech Limited, Endo USA Inc., a Keenova Therapeutics Company, Hetero Labs Limited, Unit-V, Hikma Pharmaceuticals USA Inc., Hisun Pharmaceuticals, Jubilant Cadista Pharmaceuticals, Inc., Lannett Company, Inc., Meitheal Pharmaceuticals, Inc., Mylan Pharmaceuticals Inc, Novartis Pharmaceuticals, Rising Pharma Holdings, Inc., RK Pharma Inc., Sandoz, Strides Pharma, Inc, Teva Pharmaceuticals USA, TWi Pharmaceuticals, Inc., VistaPharm, Inc., Wuxi Fortune Pharmaceutical Co., Ltd, Zydus Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01733082
- Sponsor's protocol ID
- ML22679
- Status last verified
- Oct 2026
- First submitted
- 20 Nov 2012
- Last updated
- 13 Oct 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Mycophenolate Pregnancy Registry
- ClinicalTrials.gov ID
- NCT01733082
- Acronym / sponsor ID
- ML22679
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Accord Healthcare, Inc., Alkem Laboratories Ltd, Ascend Laboratories, LLC, Amneal Pharmaceuticals, LLC, Amta labs Limited, Apotex Inc., Avet Lifesciences Limited, Azurity Pharmaceuticals, Biocon Pharma Limited, Concord Biotech Limited, Endo USA Inc., a Keenova Therapeutics Company, Hetero Labs Limited, Unit-V, Hikma Pharmaceuticals USA Inc., Hisun Pharmaceuticals, Jubilant Cadista Pharmaceuticals, Inc., Lannett Company, Inc., Meitheal Pharmaceuticals, Inc., Mylan Pharmaceuticals Inc, Novartis Pharmaceuticals, Rising Pharma Holdings, Inc., RK Pharma Inc., Sandoz, Strides Pharma, Inc, Teva Pharmaceuticals USA, TWi Pharmaceuticals, Inc., VistaPharm, Inc., Wuxi Fortune Pharmaceutical Co., Ltd, Zydus Pharmaceuticals
- Study start
- 20 Nov 2012 (actual)
- Primary completion
- 27 Aug 2026 (actual)
- Study completion
- 27 Aug 2026 (actual)
- First posted
- 26 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant Patients Exposed to Mycophenolate | – | – |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnancy and reported exposure to mycophenolate during pregnancy or within 6 weeks of discontinuing treatment
Key inclusion criteria (1 listed)
- Pregnancy and reported maternal exposure to mycophenolate during pregnancy or within 6 weeks of discontinuing treatment
Key exclusion criteria (2 listed)
- Pregnancies for which there is paternal exposure only
- Pregnancies occurring outside the U.S.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Occurrence of Educational Counseling on the Increased Risks of Birth Defects With Mycophenolate Therapy
Time frame: Approximately 13 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Genentech, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Transplantation, Kidney Transplantation, Liver Transplantation, Autoimmune Diseases, run by Genentech, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal Outcomes: Incidence of Pregnancy Complications (time frame: Approximately 13 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.