drugset / Trial / NCT00789308
Safety and Effectiveness of Low Molecular Weight Sulfated Dextran in Islet Transplantation
Phase 2
Completed
24 enrolled
National Institute of Allergy and Infectious Diseases (NIAID)
Clinical Islet Transplantation Consortium · collabNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Type 1 diabetes is an autoimmune disease in which the insulin-producing pancreatic beta cells are destroyed, resulting in poor blood sugar control. The purpose of this study is to assess the safety and effectiveness of low molecular weight sulfated dextran (LMW-SD) on post-transplant islet function in people with type 1 diabetes who have responded to intensive insulin therapy.
Timeline
- Start
- 2008-07-11
- Primary completion
- 2013-07
- Completion
- 2014-08-21
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Heparin | Other / unclassified | — | Other |
| Subject | Low Molecular Weight Sulfated Dextran | Unknown | — | Other |
| Background | ANTILYMPHOCYTE IMMUNOGLOBULIN (HORSE) | Protein / enzyme biologic | — | Intravenous |
| Background | Aspirin | Small molecule | — | — |
| Background | Basiliximab | Monoclonal antibody | — | Intravenous |
| Background | Cyclosporine | Peptide | — | — |
| Background | Enoxaparin sodium | Other / unclassified | — | — |
| Background | Etanercept | Protein / enzyme biologic | — | — |
| Background | Mycophenolate Mofetil | Small molecule | — | — |
| Background | Sirolimus | Small molecule | — | — |
| Background | Tacrolimus | Small molecule | — | — |