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 · collab National 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

Outcome

Missed primary endpoint

paper There was no difference in the primary endpoint PMID 30211831 ↗

Publications

Results von Zur-Muhlen B, Lundgren T, Bayman L, Berne C, Bridges N, Eggerman T, Foss A, Goldstein J, Jenssen T, Jorns C, Morrison Y, Ryden M, Schwieger T, Tufveson G, Nilsson B, Korsgren O. Open Randomized Multicenter Study to Evaluate Safety and Efficacy of Low Molecular Weight Sulfated Dextran in Islet Transplantation. Transplantation. 2019 Mar;103(3):630-637. doi: 10.1097/TP.0000000000002425.

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	—	—