NCT00692562

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2005

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 6, 2008

Completed
Last Updated

September 16, 2011

Status Verified

June 1, 2008

Enrollment Period

1.5 years

First QC Date

June 3, 2008

Last Update Submit

September 15, 2011

Conditions

Type 1 Diabetes MellitusEnd-stage Renal Disease

Keywords

Islets of Langerhans TransplantationKidney TransplantationType 1 Diabetes Mellitusalemtuzumab

Outcome Measures

Primary Outcomes (2)

  • Exogenous insulin requirement

    5

  • kidney function

    5

Secondary Outcomes (6)

  • Hemoglobin A1c

    5

  • Glucose and C-peptide levels

    5

  • Portal vein Ultrasound

    1

  • liver function

    5

  • Complete Blood Count

    5

  • +1 more secondary outcomes

Study Arms (1)

A

EXPERIMENTAL
Procedure: simultaneous islet-kidney transplantation

Interventions

simultaneous islet-kidney transplantationPROCEDURE
A

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuzhou General Hospital

Fuzhou, Fujian, 350025, China

Location

Related Publications (1)

  • 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.

    PMID: 18633105DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesRenal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jianming Tan, professor

    Fuzhou General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 3, 2008

First Posted

June 6, 2008

Study Start

June 1, 2005

Primary Completion

December 1, 2006

Study Completion

December 1, 2007

Last Updated

September 16, 2011

Record last verified: 2008-06

Locations

CN(1)