drugset / Trial / NCT00790439
Safety and Effectiveness of Low Molecular Weight Sulfated Dextran in Islet Transplantation After Kidney Transplant
Phase 2
Withdrawn
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Type 1 diabetes mellitus (T1D) 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 T1D who have responded to intensive insulin therapy and have received kidney transplants. This study is taking place in Uppsala and Stockholm, Sweden, and Oslo, Norway.
Timeline
- Start
- 2008-07
- Primary completion
- 2009-10
- Completion
- 2009-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Heparin | Other / unclassified | — | — |
| Subject | Low Molecular Weight Sulfated Dextran | Unknown | — | — |
| Background | Allogeneic Pancreatic Islet Cells | Cell therapy | — | Other |
| Background | Basiliximab | Monoclonal antibody | — | Intravenous |
| Background | Cyclosporine | Peptide | — | Oral |
| Background | Daclizumab | Monoclonal antibody | — | Intravenous |
| Background | Mycophenolate Mofetil | Small molecule | — | Oral |
| Background | Sirolimus | Small molecule | — | Oral |
| Background | Tacrolimus | Small molecule | — | Oral |