The Mycophenolate Pregnancy Registry

StatusCompleted
PhaseNot specified
Started

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Record History

The 50 most recent of 89 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Trial completed
    • Final enrollment: 400 participants (planned 500)
    • Primary completion date changed from estimate of Dec 31, 2040 to Aug 27, 2026
    • Site details revised
  2. Primary endpoints: details revised at 3 of 6 entries
    • Eligibility criteria expanded, about 3 words
  3. 3 versions Re-verified since Jul 9, 2026, no change to tracked fieldsv85-v87
  4. Study Status, Contacts/Locations, Referencesv84
  5. 2 versions Re-verified since Apr 14, 2026, no change to tracked fieldsv82-v83
Show 42 earlier versionsHide 42 earlier versions
  1. Primary completion date: Oct 31, 2026 to Dec 31, 2040
    • Study completion date: Dec 31, 2026 to Dec 31, 2040
    v81
  2. 3 versions Re-verified since Dec 23, 2025, no change to tracked fieldsv78-v80
  3. Primary completion date: Oct 31, 2025 to Oct 31, 2026
    • Study completion date: Dec 31, 2025 to Dec 31, 2026
    • Collaborators revised (28)
    v77
  4. 2 versions Re-verified since Sep 11, 2025, no change to tracked fieldsv75-v76
  5. Primary completion date: Aug 29, 2025 to Oct 31, 2025
    • Study completion date: Oct 31, 2025 to Dec 31, 2025
    v74
  6. Primary completion date: Jun 30, 2025 to Aug 29, 2025
    • Study completion date: Aug 29, 2025 to Oct 31, 2025
    v73
  7. Primary completion date: May 30, 2025 to Jun 30, 2025
    • Study completion date: Aug 30, 2025 to Aug 29, 2025
    v72
  8. Re-verified, no change to tracked fieldsv71
  9. Study completion date: May 30, 2025 to Aug 30, 2025v70
  10. Re-verified, no change to tracked fieldsv69
  11. Start date: Nov 30, 2012 to Nov 20, 2012v68
  12. Re-verified, no change to tracked fieldsv67
  13. Collaborators: 10 to 28v66
  14. 9 versions Re-verified since Jan 8, 2024, no change to tracked fieldsv57-v65
  15. Secondary endpoint revised
    • Primary endpoints revised (6)
    v56
  16. 16 versions Re-verified since Aug 4, 2022, no change to tracked fieldsv40-v55
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Roche/Genentech
367 trials monitored
See 31 trials at risk
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 Details
NCT Number NCT01733082
Lead Sponsor Genentech, Inc.
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
Conditions
(from sponsor)		 Heart Transplantation, Kidney Transplantation, Liver Transplantation, Autoimmune Diseases
Related terms Autoimmune Diseases
Enrollment 400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov