- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00692562
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
-
-
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
|
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
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.
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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