deltatrials
Completed PHASE2 INTERVENTIONAL 2-arm NCT00789308

Safety and Effectiveness of Low Molecular Weight Sulfated Dextran in Islet Transplantation

Open Randomized Mult-Center Study to Evaluate Safety and Efficacy of Low Molecular Weight Sulfated Dextran in Islet Transplantation (CIT-01)

Sponsor: Clinical Islet Transplantation Consortium

Conditions Diabetes Mellitus, Type I
Interventions CellCept® (Mycophenolate mofetil) OR Rapamune® (Sirolimus) Enbrel® (Etanercept) Heparin Klexane® (Enoxaparinsodium) Low Molecular Weight Sulfated Dextran (LMW-SD) Prograf® (Tacrolimus) OR Cyclosporine Simulect® (Basiliximab) - at 2nd or 3rd transplant Thymoglobulin® (Anti-thymocyte Globulin) - at first transplant Trombyl® or Albyl-E® (Acetylsalicylicacid- ASA)
Updated 7 times since 2017 Last updated: Sep 22, 2021 Started: Jul 11, 2008 Primary completion: Jul 31, 2013 Completion: Aug 21, 2014
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00789308, this PHASE2 trial focuses on Diabetes Mellitus, Type I and remains completed. Sponsored by Clinical Islet Transplantation Consortium, it has been updated 7 times since 2008, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotCompleted~Jun 2018 – ~Mar 2019 · 9 months · monthly snapshotCompleted~Mar 2019 – ~Jan 2021 · 22 months · monthly snapshotCompleted~Jan 2021 – ~Oct 2021 · 9 months · monthly snapshotCompleted~Oct 2021 – ~Jul 2024 · 33 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 24 months · monthly snapshotCompleted

Change History

7 versions recorded

  1. Sep 2024 — Present [monthly]

    Completed PHASE2

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  3. Oct 2021 — Jul 2024 [monthly]

    Completed PHASE2

  4. Jan 2021 — Oct 2021 [monthly]

    Completed PHASE2

  5. Mar 2019 — Jan 2021 [monthly]

    Completed PHASE2

▶ Show 2 earlier versions

  1. Jun 2018 — Mar 2019 [monthly]

    Completed PHASE2

  2. Jan 2017 — Jun 2018 [monthly]

    Completed PHASE2

    First recorded

Jul 2008

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Clinical Islet Transplantation Consortium
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Data source: National Institute of Allergy and Infectious Diseases (NIAID)

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

Study Locations