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

September 15, 2011 updated by: Fuzhou General Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350025
        • Fuzhou General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Procedure: simultaneous islet-kidney transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Exogenous insulin requirement
Time Frame: 5
5
kidney function
Time Frame: 5
5

Secondary Outcome Measures

Outcome Measure
Time Frame
Hemoglobin A1c
Time Frame: 5
5
Glucose and C-peptide levels
Time Frame: 5
5
Portal vein Ultrasound
Time Frame: 1
1
liver function
Time Frame: 5
5
Complete Blood Count
Time Frame: 5
5
autoantibodies
Time Frame: 5
5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fuzhou General Hospital

Investigators

  • Principal Investigator: Jianming Tan, professor, Fuzhou General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

June 3, 2008

First Submitted That Met QC Criteria

June 5, 2008

First Posted (Estimate)

June 6, 2008

Study Record Updates

Last Update Posted (Estimate)

September 16, 2011

Last Update Submitted That Met QC Criteria

September 15, 2011

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIK2005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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