deltatrials
Terminated PHASE4 INTERVENTIONAL 4-arm NCT01371344

A Paediatric, Open, Follow up Study With Modigraf Examining Safety and Efficacy in de Novo Allograft Recipients (PROGRESSION)

A Long-term, Open-label, Non-comparative Study to Evaluate the Safety and Efficacy of a Modigraf® Based Immunosuppression Regimen in Paediatric Solid Allograft Recipients

Sponsor: Astellas Pharma Europe Ltd.

Conditions Heart Transplantation Kidney Transplantation Liver Transplantation
Interventions Tacrolimus capsules Tacrolimus granules
Updated 15 times since 2017 Last updated: Oct 30, 2024 Started: Jun 24, 2011 Primary completion: Apr 2, 2017 Completion: Apr 2, 2017
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Trial will not complete until at least 2025 and evolution of immunosuppressant therapy has made it unlikely that patients will convert from Modigraf to Prograf.

Other terminated trials from Astellas Pharma Europe Ltd.

More terminations from Astellas Pharma Europe Ltd.

Other Heart Transplantation trials with similar outcome

Browse all Heart Transplantation trials

Listed as NCT01371344, this PHASE4 trial focuses on Heart Transplantation and Kidney Transplantation and remains terminated or withdrawn. Sponsored by Astellas Pharma Europe Ltd., it has been updated 15 times since 2011, reflecting substantial change activity. This study contributes longitudinal data to the cardiovascular research landscape.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Sep 2017 · 7 months · monthly snapshot~Sep 2017 – ~Dec 2017 · 3 months · monthly snapshot~Dec 2017 – ~May 2018 · 5 months · monthly snapshot~May 2018 – ~Jun 2018 · 31 days · monthly snapshot~Jun 2018 – ~Sep 2018 · 3 months · monthly snapshot~Sep 2018 – ~Jun 2019 · 9 months · monthly snapshot~Jun 2019 – ~Nov 2020 · 17 months · monthly snapshot~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshot~Jan 2021 – ~Dec 2021 · 11 months · monthly snapshot~Dec 2021 – ~Jul 2024 · 31 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Dec 2024 · 3 months · monthly snapshot~Dec 2024 – ~Sep 2025 · 9 months · monthly snapshot~Sep 2025 – present · 10 months · monthly snapshot

Change History

15 versions recorded

  1. Sep 2025 — Present [monthly]

    Terminated PHASE4

  2. Dec 2024 — Sep 2025 [monthly]

    Terminated PHASE4

  3. Sep 2024 — Dec 2024 [monthly]

    Terminated PHASE4

  4. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE4

  5. Dec 2021 — Jul 2024 [monthly]

    Terminated PHASE4

▶ Show 10 earlier versions

  1. Jan 2021 — Dec 2021 [monthly]

    Terminated PHASE4

  2. Nov 2020 — Jan 2021 [monthly]

    Terminated PHASE4

  3. Jun 2019 — Nov 2020 [monthly]

    Terminated PHASE4

  4. Sep 2018 — Jun 2019 [monthly]

    Terminated PHASE4

  5. Jun 2018 — Sep 2018 [monthly]

    Terminated PHASE4

  6. May 2018 — Jun 2018 [monthly]

    Terminated PHASE4

  7. Dec 2017 — May 2018 [monthly]

    Terminated PHASE4

    Status: Active Not Recruiting → Terminated

  8. Sep 2017 — Dec 2017 [monthly]

    Active Not Recruiting PHASE4

  9. Feb 2017 — Sep 2017 [monthly]

    Active Not Recruiting PHASE4

  10. Jan 2017 — Feb 2017 [monthly]

    Active Not Recruiting PHASE4

    First recorded

Jun 2011

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Astellas Pharma Europe Ltd.
Data source: Astellas Pharma Inc

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

Study Locations