Clinical trial NCT00692562: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Type 1 Diabetes Mellitus
End-stage Renal Disease
Keywords: Islets of Langerhans Transplantation
Kidney Transplantation
Type 1 Diabetes Mellitus
alemtuzumab
Lead sponsor: Fuzhou General Hospital
Sponsor class: OTHER
First posted: 2008-06-06
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Exogenous insulin requirement
timeFrame: 5
measure: kidney function
timeFrame: 5
Secondary outcomes:
measure: Hemoglobin A1c
timeFrame: 5
measure: Glucose and C-peptide levels
timeFrame: 5
measure: Portal vein Ultrasound
timeFrame: 1
measure: liver function
timeFrame: 5
measure: Complete Blood Count
timeFrame: 5
measure: autoantibodies
timeFrame: 5
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fuzhou General Hospital
state: Fujian
Study officials:
affiliation: Fuzhou General Hospital
name: Jianming Tan, professor
role: PRINCIPAL_INVESTIGATOR
References:
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.