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Simultaneous Islet-Kidney Transplantation in Patients of Type 1 Diabetes With End-stage Renal Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00692562
First Posted: June 6, 2008
Last Update Posted: September 16, 2011
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.
Information provided by:
Fuzhou General Hospital
  Purpose
The aim of this study was to evaluate the efficiency and safety of simultaneous islet-kidney transplantation in patients of type 1 diabetes with end-stage renal disease using a glucocorticoid-free immunosuppressive regimen with alemtuzumab induction. Islet transplantation can result in insulin independence with excellent metabolic control when glucocorticoid-free immunosuppression is combined with the infusion of an adequate islet mass. Alemtuzumab (Campath-1H ®) is a 150-kDa humanized IgG1 monoclonal antibody that targets the CD52 antigen. Prolonged lymphocyte depletion can be expected following alemtuzumab treatment.

Condition Intervention Phase
Type 1 Diabetes Mellitus End-stage Renal Disease Procedure: simultaneous islet-kidney transplantation Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Simultaneous Islet-Kidney Transplantation in Patients of Type 1 Diabetes With End-stage Renal Disease

Resource links provided by NLM:


Further study details as provided by Fuzhou General Hospital:

Primary Outcome Measures:
  • Exogenous insulin requirement [ Time Frame: 5 ]
  • kidney function [ Time Frame: 5 ]

Secondary Outcome Measures:
  • Hemoglobin A1c [ Time Frame: 5 ]
  • Glucose and C-peptide levels [ Time Frame: 5 ]
  • Portal vein Ultrasound [ Time Frame: 1 ]
  • liver function [ Time Frame: 5 ]
  • Complete Blood Count [ Time Frame: 5 ]
  • autoantibodies [ Time Frame: 5 ]

Enrollment: 7
Study Start Date: June 2005
Study Completion Date: December 2007
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Procedure: simultaneous islet-kidney transplantation

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female patients age 18 to 60 years of age.
  • Ability to provide written informed consent.
  • Clinical history compatible with type 1 diabetes (T1DM) as defined by the WHO guidelines(1999) on the Diagnosis and classification of Diabetes Mellitus.
  • manifest signs and symptoms that are severe enough to be incapacitating.
  • Basal C-peptide<0.5ng/mL
  • patients with poor diabetes control (HbA1c >7% but <12%)
  • progressive diabetic complications.
  • end-stage renal disease(serum creatinine>450μmol/l)

Exclusion Criteria:

  • age <18 years or >60 years
  • diabetic history <5 years
  • BMI>27
  • body weight >80kg
  • exogenous insulin requirement >1 unit/kg/day
  • severe anemia (male <8g/dl, female <7g/dl)
  • low white blood cell count (<3000/dl)
  • liver dysfunction
  • Symptomatic peptic ulcer disease
  • Any malignancy
  • Active infection including hepatitis B, hepatitis C, HIV, or TB
  • panel reactive antibody >20%
  • Any medical condition that, in the opinion of the investigator, will interfere with the safe completion of the trial.
  Contacts and Locations
Information from the National Library of Medicine

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): NCT00692562


Locations
China, Fujian
Fuzhou General Hospital
Fuzhou, Fujian, China, 350025
Sponsors and Collaborators
Fuzhou General Hospital
Investigators
Principal Investigator: Jianming Tan, professor Fuzhou General Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: FUZHOU GENERAL HOSPITAL
ClinicalTrials.gov Identifier: NCT00692562     History of Changes
Other Study ID Numbers: SIK2005
First Submitted: June 3, 2008
First Posted: June 6, 2008
Last Update Posted: September 16, 2011
Last Verified: June 2008

Keywords provided by Fuzhou General Hospital:
Islets of Langerhans Transplantation
Kidney Transplantation
Type 1 Diabetes Mellitus
alemtuzumab

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Kidney Diseases
Kidney Failure, Chronic
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency