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

NCT ID: NCT00692562

Last Updated: 2011-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-06-30
• Study Completion Date: 2007-12-31

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.

Conditions

Type 1 Diabetes Mellitus; End-stage Renal Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

Group Type: EXPERIMENTAL

simultaneous islet-kidney transplantation

Intervention Type: PROCEDURE

Interventions

simultaneous islet-kidney transplantation

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fuzhou General Hospital

OTHER

Sponsor Role: lead

Responsible Party

FUZHOU GENERAL HOSPITAL

Principal Investigators

Jianming Tan, professor

Role: PRINCIPAL_INVESTIGATOR

Fuzhou General Hospital

Locations

Fuzhou General Hospital

Fuzhou, Fujian, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 18633105 (View on PubMed)

Other Identifiers

SIK2005

Identifier Type: -

Identifier Source: org_study_id