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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:
Information provided by:
Fuzhou General Hospital
ClinicalTrials.gov Identifier:
NCT00692562
First received: June 3, 2008
Last updated: September 15, 2011
Last verified: June 2008
History of Changes
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Fuzhou General Hospital:

Primary Outcome Measures:
  • Exogenous insulin requirement [ Time Frame: 5 ] [ Designated as safety issue: No ]
  • kidney function [ Time Frame: 5 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hemoglobin A1c [ Time Frame: 5 ] [ Designated as safety issue: No ]
  • Glucose and C-peptide levels [ Time Frame: 5 ] [ Designated as safety issue: No ]
  • Portal vein Ultrasound [ Time Frame: 1 ] [ Designated as safety issue: Yes ]
  • liver function [ Time Frame: 5 ] [ Designated as safety issue: Yes ]
  • Complete Blood Count [ Time Frame: 5 ] [ Designated as safety issue: Yes ]
  • autoantibodies [ Time Frame: 5 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Fuzhou General Hospital

Additional 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
Study First Received: June 3, 2008
Last Updated: September 15, 2011
Health Authority: China: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 19, 2013