deltatrials
Terminated PHASE2/PHASE3 INTERVENTIONAL 5-arm NCT03523728

A Medical Research Study Designed to Determine if Venglustat Can be a Future Treatment for ADPKD Patients (STAGED-PKD)

Multicenter, Randomized, Double-blind, Placebo-controlled Two Stage Study to Characterize the Efficacy, Safety, Tolerability and Pharmacokinetics of GZ/SAR402671 in Patients at Risk of Rapidly Progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Sponsor: Genzyme, a Sanofi Company

Conditions Polycystic Kidney, Autosomal Dominant
Interventions Placebo Venglustat
Updated 39 times since 2018 Last updated: Feb 1, 2023 Started: Oct 4, 2018 Primary completion: Aug 3, 2021 Completion: Aug 3, 2021
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Interim analysis for futility of the Stage 1 of the EFC15392 study met the protocol specified stopping rule based on the primary endpoint. EFC15392 study was stopped for futility based on prespecified criteria and recommendation from DMC

Other terminated trials from Genzyme, a Sanofi Company

See all terminations from Genzyme, a Sanofi Company

This PHASE2/PHASE3 trial investigates Polycystic Kidney, Autosomal Dominant and is currently terminated or withdrawn. Genzyme, a Sanofi Company leads this study, which shows 39 recorded versions since 2018 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshot~Jul 2018 – ~Nov 2018 · 4 months · monthly snapshot~Nov 2018 – ~Dec 2018 · 30 days · monthly snapshot~Dec 2018 – ~Jan 2019 · 31 days · monthly snapshot~Jan 2019 – ~Feb 2019 · 31 days · monthly snapshot~Feb 2019 – ~Mar 2019 · 28 days · monthly snapshot~Mar 2019 – ~Apr 2019 · 31 days · monthly snapshot~Apr 2019 – ~May 2019 · 30 days · monthly snapshot~May 2019 – ~Jun 2019 · 31 days · monthly snapshot~Jun 2019 – ~Jul 2019 · 30 days · monthly snapshot~Jul 2019 – ~Aug 2019 · 31 days · monthly snapshot~Aug 2019 – ~Sep 2019 · 31 days · monthly snapshot~Sep 2019 – ~Oct 2019 · 30 days · monthly snapshot~Oct 2019 – ~Nov 2019 · 31 days · monthly snapshot~Nov 2019 – ~Dec 2019 · 30 days · monthly snapshot~Dec 2019 – ~Jan 2020 · 31 days · monthly snapshot~Jan 2020 – ~Feb 2020 · 31 days · monthly snapshot~Feb 2020 – ~Mar 2020 · 29 days · monthly snapshot~Mar 2020 – ~Apr 2020 · 31 days · monthly snapshot~Apr 2020 – ~May 2020 · 30 days · monthly snapshot~May 2020 – ~Jun 2020 · 31 days · monthly snapshot~Jun 2020 – ~Jul 2020 · 30 days · monthly snapshot~Jul 2020 – ~Sep 2020 · 2 months · monthly snapshot~Sep 2020 – ~Oct 2020 · 30 days · monthly snapshot~Oct 2020 – ~Nov 2020 · 31 days · monthly snapshot~Nov 2020 – ~Dec 2020 · 30 days · monthly snapshot~Dec 2020 – ~Jan 2021 · 31 days · monthly snapshot~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshot~Feb 2021 – ~Mar 2021 · 28 days · monthly snapshot~Mar 2021 – ~Apr 2021 · 31 days · monthly snapshot~Apr 2021 – ~Sep 2021 · 5 months · monthly snapshot~Sep 2021 – ~Dec 2021 · 3 months · monthly snapshot~Dec 2021 – ~May 2022 · 5 months · monthly snapshot~May 2022 – ~Dec 2022 · 7 months · monthly snapshot~Dec 2022 – ~Mar 2023 · 3 months · monthly snapshot~Mar 2023 – ~Jul 2024 · 16 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – present · 12 months · monthly snapshot

Change History

39 versions recorded

  1. Sep 2025 — Present [monthly]

    Terminated PHASE2/PHASE3

  2. Sep 2024 — Sep 2025 [monthly]

    Terminated PHASE2/PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE2/PHASE3

    Phase: PHASE2_PHASE3 → PHASE2/PHASE3

  4. Mar 2023 — Jul 2024 [monthly]

    Terminated PHASE2_PHASE3

  5. Dec 2022 — Mar 2023 [monthly]

    Terminated PHASE2_PHASE3

▶ Show 34 earlier versions

  1. May 2022 — Dec 2022 [monthly]

    Terminated PHASE2_PHASE3

  2. Dec 2021 — May 2022 [monthly]

    Terminated PHASE2_PHASE3

  3. Sep 2021 — Dec 2021 [monthly]

    Terminated PHASE2_PHASE3

    Status: Recruiting → Terminated

  4. Apr 2021 — Sep 2021 [monthly]

    Recruiting PHASE2_PHASE3

  5. Mar 2021 — Apr 2021 [monthly]

    Recruiting PHASE2_PHASE3

  6. Feb 2021 — Mar 2021 [monthly]

    Recruiting PHASE2_PHASE3

  7. Jan 2021 — Feb 2021 [monthly]

    Recruiting PHASE2_PHASE3

  8. Dec 2020 — Jan 2021 [monthly]

    Recruiting PHASE2_PHASE3

  9. Nov 2020 — Dec 2020 [monthly]

    Recruiting PHASE2_PHASE3

  10. Oct 2020 — Nov 2020 [monthly]

    Recruiting PHASE2_PHASE3

  11. Sep 2020 — Oct 2020 [monthly]

    Recruiting PHASE2_PHASE3

  12. Jul 2020 — Sep 2020 [monthly]

    Recruiting PHASE2_PHASE3

  13. Jun 2020 — Jul 2020 [monthly]

    Recruiting PHASE2_PHASE3

  14. May 2020 — Jun 2020 [monthly]

    Recruiting PHASE2_PHASE3

  15. Apr 2020 — May 2020 [monthly]

    Recruiting PHASE2_PHASE3

  16. Mar 2020 — Apr 2020 [monthly]

    Recruiting PHASE2_PHASE3

  17. Feb 2020 — Mar 2020 [monthly]

    Recruiting PHASE2_PHASE3

  18. Jan 2020 — Feb 2020 [monthly]

    Recruiting PHASE2_PHASE3

  19. Dec 2019 — Jan 2020 [monthly]

    Recruiting PHASE2_PHASE3

  20. Nov 2019 — Dec 2019 [monthly]

    Recruiting PHASE2_PHASE3

  21. Oct 2019 — Nov 2019 [monthly]

    Recruiting PHASE2_PHASE3

  22. Sep 2019 — Oct 2019 [monthly]

    Recruiting PHASE2_PHASE3

  23. Aug 2019 — Sep 2019 [monthly]

    Recruiting PHASE2_PHASE3

  24. Jul 2019 — Aug 2019 [monthly]

    Recruiting PHASE2_PHASE3

  25. Jun 2019 — Jul 2019 [monthly]

    Recruiting PHASE2_PHASE3

  26. May 2019 — Jun 2019 [monthly]

    Recruiting PHASE2_PHASE3

  27. Apr 2019 — May 2019 [monthly]

    Recruiting PHASE2_PHASE3

  28. Mar 2019 — Apr 2019 [monthly]

    Recruiting PHASE2_PHASE3

  29. Feb 2019 — Mar 2019 [monthly]

    Recruiting PHASE2_PHASE3

  30. Jan 2019 — Feb 2019 [monthly]

    Recruiting PHASE2_PHASE3

  31. Dec 2018 — Jan 2019 [monthly]

    Recruiting PHASE2_PHASE3

  32. Nov 2018 — Dec 2018 [monthly]

    Recruiting PHASE2_PHASE3

    Status: Not Yet Recruiting → Recruiting · Phase: PHASE3 → PHASE2_PHASE3

  33. Jul 2018 — Nov 2018 [monthly]

    Not Yet Recruiting PHASE3

  34. Jun 2018 — Jul 2018 [monthly]

    Not Yet Recruiting PHASE3

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Genzyme, a Sanofi Company
Data source: Sanofi

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Almada, Portugal , Amsterdam, Netherlands , Ashdod, Israel , Atlanta, United States , Aurora, United States , Baltimore, United States , Barcelona, Spain , Beijing, China , Berlin, Germany , Birmingham, United States and 79 more locations