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

Type 1 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00692562
• Other study ID #: SIK2005
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: June 3, 2008
• Last updated: September 15, 2011
• Start date: June 2005
• Est. completion date: December 2007

Study information

• Verified date: June 2008
• Source: Fuzhou General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: December 2007
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• End-stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Type 1 Diabetes Mellitus

Intervention

Procedure:
• simultaneous islet-kidney transplantation

Locations

Country	Name	City	State
China	Fuzhou General Hospital	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fuzhou General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exogenous insulin requirement		5	No
Primary	kidney function		5	No
Secondary	Hemoglobin A1c		5	No
Secondary	Glucose and C-peptide levels		5	No
Secondary	Portal vein Ultrasound		1	Yes
Secondary	liver function		5	Yes
Secondary	Complete Blood Count		5	Yes
Secondary	autoantibodies		5	Yes