Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00557518




Registration number
NCT00557518
Ethics application status
Date submitted
12/11/2007
Date registered
14/11/2007
Date last updated
30/01/2009

Titles & IDs
Public title
Study of Alagebrium in Patients With Insulin-Dependent Type 1 Diabetes and Microalbuminuria
Scientific title
A Randomized, Placebo-Controlled Trial of Alagebrium in Patients With Insulin-Dependent Type 1 Diabetes and Microalbuminuria
Secondary ID [1] 0 0
ALT-711-0424
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 1 0 0
Diabetic Nephropathy 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes
Renal and Urogenital 0 0 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Alagebrium
Treatment: Drugs - Placebo

Active comparator: 1 -

Placebo comparator: 2 -


Treatment: Drugs: Alagebrium
200 mg bid

Treatment: Drugs: Placebo
bid
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline in albumin excretion rate (µg/min)
Timepoint [1] 0 0
24 weeks
Secondary outcome [1] 0 0
Albumin:creatinine ratio(mg/g), plasma renin level, collagen markers, AGE related markers, 24 hour blood pressure determinations
Timepoint [1] 0 0
24 weeks

Eligibility
Key inclusion criteria
* Insulin-dependent type 1 diabetes
* Age 18-65 years
* Diagnosis of established microalbuminuria
* Blood pressure <140 mm Hg, diastolic blood pressure <90 mm Hg
* HbA1c <10%
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Body mass index >40 kg/m2
* Cardiovascular event within 6 months prior to screening
* History of acute myocardial infarction within 12 months prior to screening
* Serum creatinine >1.5 mg/dL
* Receiving chronic nonsteroidal anti-inflammatory therapy
* Receiving antihypertensive therapy except for angiotensin converting enzyme inhibitors or angiotensin receptor blockers
* Any significant systemic illnesses,medical conditions or abnormal laboratory values

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2009
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
International Diabetes Institute - Caulfield
Recruitment hospital [3] 0 0
Dept. of Clinical and Biomedical Science Myers House - Geelong
Recruitment hospital [4] 0 0
Austin Health - Heidelburg
Recruitment hospital [5] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
3162 - Caulfield
Recruitment postcode(s) [3] 0 0
3220 - Geelong
Recruitment postcode(s) [4] 0 0
3084 - Heidelburg
Recruitment postcode(s) [5] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Denmark
State/province [1] 0 0
Gentofte

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Synvista Therapeutics, Inc
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Juvenile Diabetes Research Foundation
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Mark E Cooper, MBBS, PhD
Address 0 0
Baker Heart Research Institute, Melbourne, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00557518