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

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. Identifier: NCT00692562
Recruitment Status : Completed
First Posted : June 6, 2008
Last Update Posted : September 16, 2011
Information provided by:
Fuzhou General Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus End-stage Renal Disease Procedure: simultaneous islet-kidney transplantation Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
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
Study Start Date : June 2005
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: A Procedure: simultaneous islet-kidney transplantation

Primary Outcome Measures :
  1. Exogenous insulin requirement [ Time Frame: 5 ]
  2. kidney function [ Time Frame: 5 ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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.

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 identifier (NCT number): NCT00692562

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: FUZHOU GENERAL HOSPITAL Identifier: NCT00692562     History of Changes
Other Study ID Numbers: SIK2005
First Posted: June 6, 2008    Key Record Dates
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

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