End-stage Renal Disease, Type 1 Diabetes Mellitus
Conditions
Keywords
Islets of Langerhans Transplantation, Kidney Transplantation, Type 1 Diabetes Mellitus, alemtuzumab
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.
Interventions
PROCEDUREsimultaneous islet-kidney transplantation
Sponsors
Fuzhou General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Exogenous insulin requirement | 5 |
| kidney function | 5 |
Secondary
| Measure | Time frame |
|---|---|
| Portal vein Ultrasound | 1 |
| liver function | 5 |
| Hemoglobin A1c | 5 |
| autoantibodies | 5 |
| Complete Blood Count | 5 |
| Glucose and C-peptide levels | 5 |
Countries
China
Outcome results
None listed