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

Phase 1

Completed

• Conditions: Type 1 Diabetes Mellitus; End-stage Renal Disease
• Interventions: Procedure: simultaneous islet-kidney transplantation

• Registration Number: NCT00692562
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06
• Primary Completion: 2006-12
• Study Completion: 2007-12
• Status Verified: 2008-06
• Study First Submitted: 2008-06-03
• Study First Submitted QC: 2008-06-05
• Study First Posted: 2008-06-06
• Last Update Submitted: 2011-09-15
• Last Update Posted: 2011-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	simultaneous islet-kidney transplantation	-

Primary Outcome Measures

Name	Time	Method
Exogenous insulin requirement	5
kidney function	5

Secondary Outcome Measures

Name	Time	Method
liver function	5
Complete Blood Count	5
autoantibodies	5
Hemoglobin A1c	5
Glucose and C-peptide levels	5
Portal vein Ultrasound	1

Trial Locations

Locations (1)

Fuzhou General Hospital; 🇨🇳 Fuzhou, Fujian, China