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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00790439 |
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 and have received kidney transplants. This study is taking place in Uppsala and Stockholm, Sweden, and Oslo, Norway.
Condition | Intervention | Phase |
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Diabetes Mellitus, Type I |
Drug: Low Molecular Weight Sulfated Dextran (LMW-SD) Drug: Heparin Drug: Mycopheonloate Mofetil Drug: Sirolimus Drug: Tacrolimus Drug: Cyclosporine Drug: Daclizumab Drug: Basiliximab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Open Randomized Multi-Center Study to Evaluate Safety and Efficacy of Low Molecular Weight Sulfated Dextran in Islet After Kidney Transplantation |
Estimated Enrollment: | 36 |
Study Start Date: | July 2008 |
Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
18 participants randomized to protocol immunosuppression without LMW-DS
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Drug: Heparin
Anticoagulation
Drug: Mycopheonloate Mofetil
Cell proliferation inhibitor
Drug: Sirolimus
Cell proliferation inhibitor
Drug: Tacrolimus
Calcineurin inhibitor
Drug: Cyclosporine
Calcineurin inhibitor
Drug: Daclizumab
Monoclonal IL-2 receptor blocker
Drug: Basiliximab
Monoclonal IL-2 receptor blocker
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2: Experimental
18 participants randomized to protocol immunosuppression with LMW-DS and without LMW-DS
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Drug: Low Molecular Weight Sulfated Dextran (LMW-SD)
Inhibitor of IBMIR
Drug: Mycopheonloate Mofetil
Cell proliferation inhibitor
Drug: Sirolimus
Cell proliferation inhibitor
Drug: Tacrolimus
Calcineurin inhibitor
Drug: Cyclosporine
Calcineurin inhibitor
Drug: Daclizumab
Monoclonal IL-2 receptor blocker
Drug: Basiliximab
Monoclonal IL-2 receptor blocker
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Type 1 diabetes is commonly treated with the administration of insulin, either by multiple insulin injections or by a continuous supply of insulin through a wearable pump. Insulin therapy allows long-term survival in individuals with type 1 diabetes; however, it does not guarantee constant normal blood sugar control. Because of this, long-term type 1 diabetic survivors often develop vascular complications, such as diabetic retinopathy, an eye disease that can cause poor vision and blindness, and diabetic nephropathy, a kidney disease that can lead to kidney failure and thus kidney transplant. Some individuals with type 1 diabetes develop hypoglycemia unawareness, a life-threatening condition that is not easily treatable with medication and is characterized by reduced or absent warning signals for hypoglycemia. For such individuals, pancreas or pancreatic islet transplantation are possible treatment options. Rejection of these islets by the recipient's immune system, however, can make the treatment ineffective. An immune response known as instant blood-mediated inflammatory reaction (IBMIR) results in the disruption of islet integrity and islet loss within an hour of transfusion. LMW-SD inhibits IBMIR by preventing the cascade that triggers it, when combined with pancreatic islets. The purpose of this study is to determine the safety and efficacy of LMW-SD given with islet transfusion and post-transfusion, along with immunosuppressive therapy, in people who have received kidney transplants.
This study will last for 1 year. Participants eligible for this study will have clinic visits every 3 months. Once a preparation of islets becomes available, participants will be will be randomly assigned to Arm 1 or Arm 2. Participants in Arm 1 will receive LMW-SD during and for 5 hours after transfusion. Participants in Arm 2 will heparin at the time of transfusion. All participants will also receive the oral medications, mycophenolate mofetil or sirolimus and tacrolimus or cyclosporine throughout the study. In addition, they will receive intravenous daclizumab at time of transfusion and at Week 2, 4, 6, and 8 or intravenous basiliximab at the time of transplant and on Day 4. Transfusions will occur at the hospital and will be given intravenously. All participants will be eligible to receive second and third islet transfusions if previous transfusions fail. After each transfusion, study visits will occur on Days 1, 3, 7, 14, 21, 28, 75, and Months 6 and 12. At these visits, physical exams and blood collection will occur. At some visits urine collection will also occur.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Severe coexisting cardiac disease, characterized by any one of the following conditions:
Contact: Yvonne Morrison | 301-451-3139 | ymorrison@niaid.nih.gov |
Norway | |
University Hospital Rikshospitalet | Not yet recruiting |
Oslo, Norway | |
Contact: Janicke Narverud janicke.narverud@rikshospitalet.no | |
Principal Investigator: Aksel Foss, MD | |
Sweden | |
Uppsala University Hospital | Recruiting |
Uppsala, Sweden | |
Contact: Maria Svenaeus-Lundgren maria.svenaeus.lundgren@akademiska.se | |
Principal Investigator: Gunnar Tufveson, MD | |
Karolinska University Hospital | Recruiting |
Stokhom, Sweden | |
Contact: Ingemo Sundberg-Petersson ingemo.sundberg-petersson@karolinska.se | |
Principal Investigator: Annika Tibell, MD |
Principal Investigator: | Olle Korsgren, MD | Department of Oncology, Radiology, and Clinical Immunology, Rudbeck Laboratory, Uppsala University Hospital |
Responsible Party: | DAIT/NIAID ( Associate Director, Clinical Research Program ) |
Study ID Numbers: | DAIT CIT-01B, CIT-01B |
Study First Received: | November 10, 2008 |
Last Updated: | November 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00790439 |
Health Authority: | United States: Federal Government |
Insulin dependence |
Sirolimus Metabolic Diseases Autoimmune Diseases Cyclosporine Clotrimazole Miconazole Daclizumab Tioconazole Diabetes Mellitus Endocrine System Diseases Tacrolimus |
Cyclosporins Insulin Calcium heparin Body Weight Basiliximab Diabetes Mellitus, Type 1 Endocrinopathy Glucose Metabolism Disorders Metabolic disorder Heparin Dextrans |
Anti-Infective Agents Anticoagulants Immune System Diseases Molecular Mechanisms of Pharmacological Action Immunologic Factors Hematologic Agents Physiological Effects of Drugs Enzyme Inhibitors |
Immunosuppressive Agents Pharmacologic Actions Antifungal Agents Therapeutic Uses Blood Substitutes Plasma Substitutes Antirheumatic Agents Dermatologic Agents |