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

Sponsor

Fuzhou General Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00692562

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

Actual Enrollment :

7 participants

Allocation:

N/A

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 :

Jun 1, 2005

Actual Primary Completion Date :

Dec 1, 2006

Actual Study Completion Date :

Dec 1, 2007

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: A

Procedure: simultaneous islet-kidney transplantation

Outcome Measures

Primary Outcome Measures

Exogenous insulin requirement [5]
kidney function [5]

Secondary Outcome Measures

Hemoglobin A1c [5]
Glucose and C-peptide levels [5]
Portal vein Ultrasound [1]
liver function [5]
Complete Blood Count [5]
autoantibodies [5]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.