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

900 Hospital of the People's Liberation Army Joint Logistic Support Force

Status and phase

Completed

Phase 2

Phase 1

Conditions

Type 1 Diabetes Mellitus

End-stage Renal Disease

Treatments

Procedure: simultaneous islet-kidney transplantation

Study type

Interventional

Funder types

Other

Identifiers

NCT00692562

SIK2005

Details and patient eligibility

About

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.

Enrollment

7 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No 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.