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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
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
University Hospital, Lille

May 11, 2010
May 14, 2010
January 10, 2018
March 2003
March 2014   (Final data collection date for primary outcome measure)
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).
Composite criteria: insulin independence and Glycosylated Hemoglobin (HbA1c) under 6.5% at one year after the transplantation [ Time Frame: One year ]
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).
Complete list of historical versions of study NCT01123187 on ClinicalTrials.gov Archive Site
  • 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)
Same as current
Not Provided
Not Provided
 
Islet Cell Transplantation in Patients With Type I Diabetes With Previous Kidney Transplantation
Phase 2 Study of Islet Cell Transplantation in Patients With Type I Diabetes With Previous Kidney Transplantation With Steroid Free Immunosuppression
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.

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.

Interventional
Not Applicable
Intervention Model: Single Group Assignment
Intervention Model Description:
Islet transplantation
Masking: None (Open Label)
Primary Purpose: Treatment
  • Type 1 Diabetes
  • Organ Transplantation
  • Immunosuppression
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.
Other Names:
  • surgical catheterisation
  • percutaneous catheterisation
Experimental: islet transplantation
Islet transplantation
Intervention: Procedure: islet transplantation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
19
April 2016
March 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 1 diabetes mellitus. Documentation of negative basal and stimulated C-peptide and diagnosis of diabetes for at least 5 years.
  • Recipient of renal transplant with good function (creatinine clearance >/=60 ml/min)
  • Stable immunosuppression consisting of any combination of sirolimus, tacrolimus for at least 6 months, without major complications
  • Ability to give informed consent.
  • Age greater than or equal to 18 years or less than or equal to 65 years
  • No evidence of liver disease (liver enzymes < twice the upper limit of normal)

Exclusion Criteria:

  • Age below 18 years and above 65 years
  • Significant cardiovascular disease, including non-correctable coronary artery disease and/or recent myocardial infarction(within last 12 months); extensive peripheral vascular disease not correctable by surgery, unstable angina
  • Untreated proliferative retinopathy.
  • Recent Cerebrovascular accident (within last 12 months)
  • Recent unresolved acute infection, or chronic infection, including tuberculosis, HIV, HBV, HCV, CMV or positive skin test for TB
  • Any history of malignancy, except squamous or basal skin cancer or in situ cancer of the cervix.
  • History of non-compliance, or inability to demonstrate capacity to comply with strict blood glycemic control and insulin pump therapy.
  • Psychiatric illness that is untreated, or likely to interfere significantly with transplantation despite treatment.
  • Pregnant women, women intending future pregnancy, women of reproductive potential who are unable or unwilling to follow effective contraceptive measures for the duration of immunosuppressive therapy
  • Fasting C-peptide > 0.2 ng/ml
  • Creatinine > 25mg/l
  • Alkaline phosphatase, total bilirubin, Alanine Aminotransferase (ALT)or Aspartate Aminotransferase (AST) > twice the upper limit of normal
  • Significant liver disease (elevation of liver enzymes > twice the upper limit of normal for each of ALT and AST, liver masses including portal vein thrombosis, evidence of portal hypertension, or significant, untreated gallbladder disease (i.e., gallstones).
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01123187
CP 95/120
98001 ( Other Identifier: Sponsor )
DGS 980032 ( Other Identifier: AFSSAPS )
Yes
Not Provided
Plan to Share IPD: No
University Hospital, Lille
University Hospital, Lille
Institut National de la Santé Et de la Recherche Médicale, France
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
University Hospital, Lille
January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP