NCT00409461

Brief Summary

Proof of concept study in islet transplantation, two treatment arms (ATG SIR-TAC versus ATG SIR) each consisting of ten type 1 diabetic patients

Trial Health

35
At Risk

Trial Health Score

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

Geographic Reach
1 country

2 active sites

Status
terminated

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

First Submitted

Initial submission to the registry

December 8, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 11, 2006

Completed
Last Updated

December 11, 2006

Status Verified

December 1, 2006

First QC Date

December 8, 2006

Last Update Submit

December 8, 2006

Conditions

Islet TransplantationType 1 Diabetes

Interventions

ATG-Sirolimus-TacrolimusDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 1 insulin-dependent diabetic patients
  • C-peptide \< 0.15 nmol/l (\<0.45 µg/l) 6 min. after glucagon IV (1mg) (glycemia \> 180 mg/dl)
  • diabetic nephropathy
  • hypoglycaemic unawareness

You may not qualify if:

  • smoker before transplantation
  • plasma creatinine \> 2 mg/dl
  • albuminuria \>1000 mg/24 hrs
  • abnormal liver function
  • history of thrombosis or pulmonary embolism
  • history of malignancy, tuberculosis or chronic viral hepatitis
  • history of any other serious illness which could be relevant for the protocol
  • HLA antibodies
  • EBV antibody negative
  • HIV 1 \& 2 antibody positive

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Academisch Ziekenhuis and Diabetes Research Center - Brussels Free University-VUB

Brussels, 1090, Belgium

Location

Department of Endocrinology and Nephrology, UZ Gasthuisberg, Katholieke Universiteit Leuven -KUL

Leuven, 3000, Belgium

Location

Related Publications (1)

  • Gillard P, Ling Z, Mathieu C, Crenier L, Lannoo M, Maes B, Roep B, Gorus F, Pipeleers D, Keymeulen B. Comparison of sirolimus alone with sirolimus plus tacrolimus in type 1 diabetic recipients of cultured islet cell grafts. Transplantation. 2008 Jan 27;85(2):256-63. doi: 10.1097/TP.0b013e31815e8926.

    PMID: 18212631DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Bart Keymeulen, MD, PhD

    AZ-VUB

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 8, 2006

First Posted

December 11, 2006

Last Updated

December 11, 2006

Record last verified: 2006-12

Locations

BE(2)