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NCT Number: NCT00692562

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

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.

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Chronic Disease Diabetes Mellitus Diabetes Mellitus, Type 1 Disease Attributes End-stage Renal Disease Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Immune System Diseases Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Fuzhou General Hospital

Fuzhou, Fujian, 350025, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

simultaneous islet-kidney transplantation

Procedure

Primary outcomes

  1. Exogenous insulin requirement

    Time frame: 5

  2. kidney function

    Time frame: 5

Secondary outcomes

  1. Hemoglobin A1c

    Time frame: 5

  2. Glucose and C-peptide levels

    Time frame: 5

  3. Portal vein Ultrasound

    Time frame: 1

  4. liver function

    Time frame: 5

  5. Complete Blood Count

    Time frame: 5

  6. autoantibodies

    Time frame: 5

Sponsors and collaborators

Lead sponsor

Fuzhou General Hospital

Other

Registry information

Important dates

Study start
2005
Primary completion
2006
Study completion
2007
First posted
Jun 6, 2008
Registry last updated
Sep 16, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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