Islet Cell Transplantation in Patients With Type I Diabetes With Previous Kidney Transplantation
This single center phase 2 clinical trial, is designed for confirming the efficacy and safety of sequential islet allotransplantation with steroid free immunosuppression in patients with previous kidney transplantation.
Type 1 Diabetes
Procedure: islet transplantation
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase 2 Study of Islet Cell Transplantation in Patients With Type I Diabetes With Previous Kidney Transplantation With Steroid Free Immunosuppression|
- Composite criteria: insulin independence and Glycosylated Hemoglobin (HbA1c) under 6.5% at one year after the transplantation [ Time Frame: One year ] [ Designated as safety issue: No ]Percent of insulin-independent patients with a Glycosylated Hemoglobin (HbA1c) under 6.5% at one year after injection of approximately 10,000 islets equivalents / kg (IE/kg).
- The number of adverse events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]The number of adverse events related to the procedure and to the immunosuppression
- Number of severe episodes of hypoglycemia [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]Number of severe episodes of hypoglycemia (requiring the use of third)
- Evaluation of Diabetes complications [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]Evaluation of Diabetes complications: retinopathy, neuropathy, nephropathy
- Lipid metabolism [ Time Frame: 1 year ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]Evaluation of kidney function (creatinine, creatinine clearance,proteinurie)
|Study Start Date:||March 2003|
|Estimated Study Completion Date:||March 2015|
|Estimated Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
|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.
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 < 6.5% 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01123187
|Contact: Violeta Raverdy, MD||0033 320 62 34 firstname.lastname@example.org|
|Contact: Francois Pattou, MD, Premail@example.com|
|University Hospital of Lille||Recruiting|
|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|