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

Study Overview
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Brief Summary
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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.

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

Conditions
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Type 1 Diabetes Mellitus, End-stage Renal Disease

Intervention / Treatment
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* Procedure: simultaneous islet-kidney transplantation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Procedure: simultaneous islet-kidney transplantation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exogenous insulin requirement |  | 5 | 
| kidney function |  | 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1c |  | 5 | 
| Glucose and C-peptide levels |  | 5 | 
| Portal vein Ultrasound |  | 1 | 
| liver function |  | 5 | 
| Complete Blood Count |  | 5 | 
| autoantibodies |  | 5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Islets of Langerhans Transplantation, Kidney Transplantation, Type 1 Diabetes Mellitus, alemtuzumab