Islet Cell Transplantation in Patients With Type I Diabetes With Previous Kidney Transplantation
|ClinicalTrials.gov Identifier: NCT01123187|
Recruitment Status : Completed
First Posted : May 14, 2010
Last Update Posted : January 10, 2018
|Condition or disease||Intervention/treatment|
|Type 1 Diabetes Organ Transplantation Immunosuppression||Procedure: islet transplantation|
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|
|Primary Completion Date :||March 2014|
|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)
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|