Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000380594
Ethics application status
Approved
Date submitted
28/08/2006
Date registered
29/08/2006
Date last updated
29/08/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
An Open Label, Dose Titration Study Of Sevelamer Carbonate Dosed Three Times A Day In Hyperphosphatemic Chronic Kidney Disease (CKD) Patients Not On Dialysis
Scientific title
An Open Label, Dose Titration Study of Sevelamer Carbonate dosed Three Times A Day in the control of phosphorus levels in Hyperphosphatemic Chronic Kidney Disease Patients Not On Dialysis
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hyperphosphatemia in CKD Patients not on Dialysis 1346 0
Condition category
Condition code
Renal and Urogenital 1436 1436 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will test an 8-week treatment course of the investigational drug Sevelamer Carbonate, at doses from 4.8g up to 12g orally daily, in patients with Hyperphosphatemic CKD not on dialysis.
Intervention code [1] 1330 0
Treatment: Drugs
Comparator / control treatment
No comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 1973 0
The change from baseline (Day 0) to Day 56/early termination (ET) in serum phosphorus.
Timepoint [1] 1973 0
At baseline (day 0) and day 56
Secondary outcome [1] 3436 0
Serum calcium-phosphorus product
Timepoint [1] 3436 0
Baseline and study day 56.
Secondary outcome [2] 3437 0
Serum lipid profile
Timepoint [2] 3437 0
Baseline and study day 56.
Secondary outcome [3] 3438 0
Percent responders
Timepoint [3] 3438 0
Baseline and study day 56.

Eligibility
Key inclusion criteria
CKD patients not on dialysis; documented hyperphosphatemia without the use of a phosphate binder or after washout from current phosphate binder; signed informed consent.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Known hypersensitivity to the investigational product or any constituents of the study drug; active bowel obstruction, dysphagia, swallowing disorder or severe gastrointestinal (GI) motility disorders; in the opinion of the investigator, patient has poorly controlled diabetes mellitus, poorly controlled hypertension, active vasculitis, HIV infection, or any clinically significant unstable medical condition; pregnant or breast-feeding; evidence of active malignancy except for basal cell carcinoma of the skin; unable to comply with the requirements of the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 391 0
United Kingdom
State/province [1] 391 0

Funding & Sponsors
Funding source category [1] 1567 0
Commercial sector/Industry
Name [1] 1567 0
Genzyme Corporation
Country [1] 1567 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Genzyme Corporation, USA
Address
Country
United States of America
Secondary sponsor category [1] 1382 0
Commercial sector/Industry
Name [1] 1382 0
Novotech (Australia) Pty Ltd
Address [1] 1382 0
Country [1] 1382 0
Australia

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 27937 0
Address 27937 0
Country 27937 0
Phone 27937 0
Fax 27937 0
Email 27937 0
Contact person for public queries
Name 10519 0
Manjula Kishoon
Address 10519 0
Novotech (Australia) Pty Ltd
19 Harris Street
Pyrmont NSW 2009
Country 10519 0
Australia
Phone 10519 0
+61 2 9518 9600
Fax 10519 0
Email 10519 0
[email protected]
Contact person for scientific queries
Name 1447 0
Jeremy Heaton, MD
Address 1447 0
Medical Director, Renal
Genzyme Europe Research
310 Cambridge Science Park
Milton Road, Cambridge
Country 1447 0
United Kingdom
Phone 1447 0
+44 1223 394 053
Fax 1447 0
Email 1447 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.