Comparison of Sirolimus Alone With Sirolimus Plus Tacroli... | NCT00409461

Studies
Comparison of Sirolimus Alone With Sirolimus Plus Tacrolimus in Type 1 Diabetic Recipients of Cultured Islet Cell Grafts

NCT00409461

Sponsor

Universitair Ziekenhuis Brussel

Status

Terminated

Last Update Posted

Dec 11, 2006Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Islet Transplantation
Type 1 Diabetes

Interventions

ATG-Sirolimus-Tacrolimus

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2006

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Dec 8, 2006

First Submission Date that Met QC Criteria

Dec 8, 2006

First Posted Date

Dec 11, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 8, 2006

Last Update Posted Date

Dec 11, 2006Estimated

Name	Class
Fund for Scientific Research, Flanders, Belgium	OTHER
Belgian Government	OTHER_GOV

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
ATG-Sirolimus-Tacrolimus	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Not provided

Sex

Not provided

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bart Keymeulen, MD, PhD	Universitair Ziekenhuis Brussel	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Academisch Ziekenhuis and Diabetes Research Center - Brussels Free University-VUB		Brussels		1090	Belgium

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18212631	Derived	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.

ID	Type	Description	Link
G.0375.00
G.0084.02
GOA/2004/10

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases