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Trial record 24 of 27 for:    Clotrimazole AND Fungal Infections

B-Lymphocyte Immunotherapy in Islet Transplantation for Initial Islet Graft Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01049633
Expanded Access Status : No longer available
First Posted : January 14, 2010
Last Update Posted : June 11, 2014
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Tracking Information
First Submitted Date January 12, 2010
First Posted Date January 14, 2010
Last Update Posted Date June 11, 2014
 
Descriptive Information
Brief Title B-Lymphocyte Immunotherapy in Islet Transplantation for Initial Islet Graft Failure
Brief 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 determine the safety and effectiveness of islet transplantation, combined with immunosuppressive medications and medications to support islet survival for treating type 1 diabetes in individuals experiencing hypoglycemia unawareness and severe hypoglycemic episodes.
Detailed Description 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. 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. Insulin independence among islet transplant recipients tends to decline over time. New strategies aimed at promoting engraftment of transplanted islets are needed to improve the clinical outcomes associated with this procedure.
Study Type Expanded Access
Intervention
  • Biological: Allogeneic Pancreatic Islet Cells
    200mL sterile suspension of allogeneic human pancreatic islets
  • Drug: Sirolimus
    Dosed to maintain whole blood 24-hr trough levels 10-15ng/mL for first 3 months and 8-12ng/mL thereafter daily. Sirolimus is used to prevent transplant rejection.
  • Biological: Basiliximab
    20mg intravenously (IV) 2hrs prior to islet infusion and on Day 4 post-transplant. Basiliximab is used to prevent transplant rejection
  • Drug: Tacrolimus
    Initial dose of 0.015mg/kg p.o. daily on Day 1 post transplant, and adjusted to maintain 12-hr trough levels 3-6ng/mL. Tacrolimus lowers the risk of organ rejection
  • Drug: Antibacterial, Antifungal, and Antiviral Prophylaxis
    Broad spectrum antimicrobial prophylaxis administered preoperatively
  • Drug: Trimethoprim/sulfamethoxazole
    80mg/400mg by mouth once a day starting on Day 1 for duration of the study follow-up. This medication is used to prevent bacterial infections.
    Other Name: Septra SS
  • Drug: Clotrimazole
    1 troche by mouth 4 times daily starting two days prior to transplant until 3 months after the transplant. This medication is used to prevent fungal infections.
    Other Name: Mycelex Troche
  • Drug: Valganciclovir
    450mg dose by mouth once a day starting two days pre-transplant and increasing to 900 mg once a day by Day 12 and continuing for 14 weeks post-transplant. This medication is used to prevent cytomegalovirus infections.
    Other Name: Valcyte
  • Drug: Heparin
    70U/kg body weight of recipient given with islet infusion, followed by 3U/kg/hr for the next 4hrs. From 5th through 48th hr post-transplant heparin will be titrated to achieve and maintain a Partial Thromboplastin Time (PTT) of 50-60 seconds. This medication is used to prevent the formation of blood clots.
    Other Name: Anticoagulation and Hematological Agent
  • Drug: Enoxaparin
    30mg subcutaneously twice a day from 48 hrs post-transplant through Day 7 post-transplant. This medication is used to prevent the formation of blood clots.
    Other Name: Lovenox; Anticoagulation and Hematological Agent
  • Drug: Pentoxifylline
    400mg slow release tablet by mouth three times a day beginning 2 days prior to transplant and continue for 7 days post transplant. This medication improves blood flow.
    Other Name: Anticoagulation and Hematological Agent
  • Drug: Aspirin
    81mg enteric coated aspirin by mouth every night, starting 24hrs post-transplant. This medication prevents blood clots.
    Other Names:
    • ASA
    • Anticoagulation and Hematological Agent
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Expanded Access Status No longer available
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01049633
Responsible Party National Institute of Allergy and Infectious Diseases (NIAID)
Study Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators Not Provided
PRS Account National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date June 2014