Islet Cell Transplantation in Patients With Type I Diabetes With Previous Kidney Transplantation
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|ClinicalTrials.gov Identifier: NCT01123187|
Recruitment Status : Completed
First Posted : May 14, 2010
Last Update Posted : January 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Organ Transplantation Immunosuppression||Procedure: islet transplantation||Not Applicable|
The beneficial effects of glycemic control on both survival and function of transplanted kidneys in patients with type 1 diabetes mellitus have been recognized.
The purpose of this study is to reverse hyperglycemia and insulin dependency, by islet cell transplantation, in patients with type 1 diabetes mellitus who have a stable kidney allograft.
The study primary efficacy endpoint is graft survival defined as insulin independence and HbA1c < 8% at 1 year post first transplant. Secondary outcomes are graft function and metabolic control
The immunosuppression protocol for the kidney graft was converted to sirolimus+tacrolimus regimen 6 months before islet transplantation to exclude negative effects on kidney graft function.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Islet transplantation|
|Masking:||None (Open Label)|
|Official Title:||Phase 2 Study of Islet Cell Transplantation in Patients With Type I Diabetes With Previous Kidney Transplantation With Steroid Free Immunosuppression|
|Study Start Date :||March 2003|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||April 2016|
Experimental: islet transplantation
Procedure: islet transplantation
Islet transplantation consisted of up to three sequential fresh islet infusions within three months. Access to the portal vein was gained under general anesthesia by percutaneous catheterisation of a peripheral portal branch under ultrasound guidance or by surgical catheterisation of a small mesenteric vein.
- Composite criteria: insulin independence and Glycosylated Hemoglobin (HbA1c) under 8% at one year after the transplantation [ Time Frame: One year ]Percent of insulin-independent patients with a Glycosylated Hemoglobin (HbA1c) under 8% at one year after injection of approximately 10,000 islets equivalents / kg (IE/kg).
- The number of adverse events [ Time Frame: 1 year ]The number of adverse events related to the procedure and to the immunosuppression
- Number of severe episodes of hypoglycemia [ Time Frame: 1 year ]Number of severe episodes of hypoglycemia (requiring the use of third)
- Evaluation of Diabetes complications [ Time Frame: 1 year ]Evaluation of Diabetes complications: retinopathy, neuropathy, nephropathy
- Lipid metabolism [ Time Frame: 1 year ]Lipid metabolism assessed by measurement of total cholesterol and HDL cholesterol, triglycerides, ApoA1, apoB, apoE, free fatty acids and lipid.
- Evaluation of kidney function [ Time Frame: 1 year ]Evaluation of kidney function (creatinine, creatinine clearance,proteinurie)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01123187
|University Hospital of Lille|
|Lille, Nord, France, 59000|
|Principal Investigator:||François PATTOU, MD, PhD||University Hospital, Lille|
|Principal Investigator:||Marie-Christine VANTYGHEM, MD||University Hospital, Lille|
|Principal Investigator:||Christian NOEL, MD||University Hospital, Lille|
|Principal Investigator:||Julie KERR-CONTE, MD||Université de Lille 2|