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

Primary Purpose

Type 1 Diabetes Mellitus, End-stage Renal Disease

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
simultaneous islet-kidney transplantation
Sponsored by
Fuzhou General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring Islets of Langerhans Transplantation, Kidney Transplantation, Type 1 Diabetes Mellitus, alemtuzumab

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • Fuzhou General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A

Arm Description

Outcomes

Primary Outcome Measures

Exogenous insulin requirement
kidney function

Secondary Outcome Measures

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

Full Information

First Posted
June 3, 2008
Last Updated
September 15, 2011
Sponsor
Fuzhou General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00692562
Brief Title
Simultaneous Islet-Kidney Transplantation in Patients of Type 1 Diabetes With End-stage Renal Disease
Official Title
Simultaneous Islet-Kidney Transplantation in Patients of Type 1 Diabetes With End-stage Renal Disease
Study Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Fuzhou General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus, End-stage Renal Disease
Keywords
Islets of Langerhans Transplantation, Kidney Transplantation, Type 1 Diabetes Mellitus, alemtuzumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
simultaneous islet-kidney transplantation
Primary Outcome Measure Information:
Title
Exogenous insulin requirement
Time Frame
5
Title
kidney function
Time Frame
5
Secondary Outcome Measure Information:
Title
Hemoglobin A1c
Time Frame
5
Title
Glucose and C-peptide levels
Time Frame
5
Title
Portal vein Ultrasound
Time Frame
1
Title
liver function
Time Frame
5
Title
Complete Blood Count
Time Frame
5
Title
autoantibodies
Time Frame
5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianming Tan, professor
Organizational Affiliation
Fuzhou General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fuzhou General Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350025
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
18633105
Citation
Tan J, Yang S, Cai J, Guo J, Huang L, Wu Z, Chen J, Liao L. Simultaneous islet and kidney transplantation in seven patients with type 1 diabetes and end-stage renal disease using a glucocorticoid-free immunosuppressive regimen with alemtuzumab induction. Diabetes. 2008 Oct;57(10):2666-71. doi: 10.2337/db08-0358. Epub 2008 Jul 15.
Results Reference
derived

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

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