Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00704483




Registration number
NCT00704483
Ethics application status
Date submitted
23/06/2008
Date registered
25/06/2008
Date last updated
19/12/2020

Titles & IDs
Public title
Efficacy of SBR759 in Lowering Serum Phosphate Levels in Chronic Kidney Disease Patients on Hemodialysis
Scientific title
A 12-week, Open Label, Multicenter, Titration Study, With a 9-month Maintenance Treatment Extension, to Demonstrate Efficacy of SBR759 Compared to Sevelamer HCl in Lowering Serum Phosphate Levels in Chronic Kidney Disease Patients on Hemodialysis
Secondary ID [1] 0 0
EUDRACT No.: 2006-001787-23
Secondary ID [2] 0 0
CSBR759A2201
Universal Trial Number (UTN)
Trial acronym
SBR759
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hyperphosphatemia Patients With Chronic Kidney Disease on 3x/Week Replacement Therapy 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SBR759
Treatment: Drugs - Sevelamer HCl
Treatment: Drugs - SBR759
Treatment: Drugs - Sevelamer HCl

Experimental: 1 - 1g tid

Active Comparator: 2 - Sevelamer HCl

Experimental: 3 - SBR759 1.5 g tid

Active Comparator: 4 - Sevelamer HCl


Treatment: Drugs: SBR759
Starting dose of 1g or 1.5g tid, with an increase of 1g tid every 2 weeks until serum phosphate level fall below target.

Treatment: Drugs: Sevelamer HCl
0.8 g tid

Treatment: Drugs: SBR759
1.5 g tid

Treatment: Drugs: Sevelamer HCl
1.6 g tid
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Responder rates in target serum phosphate levels at 12 weeks Evaluate efficacy of SBR759 compared to sevelamer HCl at 12 weeks
Timepoint [1] 0 0
Time Frame: 12 weeks + 12 months
Secondary outcome [1] 0 0
Responder rates in target patients with serum calcium-phosphate levels at 12 weeks/12 months
Timepoint [1] 0 0
Time Frame: 12 weeks / 12 months

Eligibility
Key inclusion criteria
Inclusion criteria

- Men or women of at least 18 years old.

- Stable maintenance of renal replacement therapy 3 times per week.

- Controlled Serum phosphate if under phosphate-binder therapy.

- Serum phosphate level = 6.0 mg/dL (> 1.9 mmol/L) prior to study treatment initiation.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria

- Peritoneal dialysis.

- Parathyroidectomy or transplant scheduled during the study.

- Uncontrolled hyperparathyroidism

- History of hemochromatosis or ferritin > 1000 µg/L.

- Clinically significant GI disorder

- Unstable medical condition other than Chronic Kidney Disease.

- Treated with oral iron.

- Other protocol-defined inclusion/exclusion criteria may apply.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
321
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
Novartis - Adelaide
Recruitment hospital [2] 0 0
Novartis - Fitzroy
Recruitment hospital [3] 0 0
Novartis - Parkville
Recruitment hospital [4] 0 0
Novartis - Melbourne
Recruitment hospital [5] 0 0
Novartis - South Brisbane
Recruitment hospital [6] 0 0
Novartis - Woolloongabba
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Fitzroy
Recruitment postcode(s) [3] 0 0
3052 - Parkville
Recruitment postcode(s) [4] 0 0
3065 - Melbourne
Recruitment postcode(s) [5] 0 0
- South Brisbane
Recruitment postcode(s) [6] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Indiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Nebraska
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
North Dakota
Country [11] 0 0
United States of America
State/province [11] 0 0
Oregon
Country [12] 0 0
United States of America
State/province [12] 0 0
Pennsylvania
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Virginia
Country [15] 0 0
Belgium
State/province [15] 0 0
Antwerpen
Country [16] 0 0
Belgium
State/province [16] 0 0
Brugge
Country [17] 0 0
Belgium
State/province [17] 0 0
Bruxelles
Country [18] 0 0
Belgium
State/province [18] 0 0
Liege
Country [19] 0 0
Belgium
State/province [19] 0 0
Saint Niklaas
Country [20] 0 0
Canada
State/province [20] 0 0
Edmonton
Country [21] 0 0
Canada
State/province [21] 0 0
London
Country [22] 0 0
Canada
State/province [22] 0 0
Oshawa
Country [23] 0 0
Canada
State/province [23] 0 0
Quebec
Country [24] 0 0
Finland
State/province [24] 0 0
Helsinki
Country [25] 0 0
Finland
State/province [25] 0 0
Oulu
Country [26] 0 0
Finland
State/province [26] 0 0
Tampere
Country [27] 0 0
Finland
State/province [27] 0 0
Turku
Country [28] 0 0
France
State/province [28] 0 0
Amiens
Country [29] 0 0
France
State/province [29] 0 0
Fleury Merogis
Country [30] 0 0
France
State/province [30] 0 0
Lyon Cedex
Country [31] 0 0
France
State/province [31] 0 0
Rheims Cedex
Country [32] 0 0
France
State/province [32] 0 0
Salouel
Country [33] 0 0
Germany
State/province [33] 0 0
Berlin
Country [34] 0 0
Germany
State/province [34] 0 0
Coburg
Country [35] 0 0
Italy
State/province [35] 0 0
Lecco
Country [36] 0 0
Italy
State/province [36] 0 0
Lodi
Country [37] 0 0
Italy
State/province [37] 0 0
Milano
Country [38] 0 0
Italy
State/province [38] 0 0
Modena
Country [39] 0 0
Italy
State/province [39] 0 0
Pavia
Country [40] 0 0
Norway
State/province [40] 0 0
Bergen
Country [41] 0 0
Norway
State/province [41] 0 0
Kristiansand
Country [42] 0 0
Norway
State/province [42] 0 0
Oslo
Country [43] 0 0
Norway
State/province [43] 0 0
Tonsberg
Country [44] 0 0
Puerto Rico
State/province [44] 0 0
San Juan
Country [45] 0 0
Sweden
State/province [45] 0 0
Jonkoping
Country [46] 0 0
Sweden
State/province [46] 0 0
Karlstad
Country [47] 0 0
Sweden
State/province [47] 0 0
Skovde
Country [48] 0 0
Sweden
State/province [48] 0 0
Stockholm
Country [49] 0 0
Switzerland
State/province [49] 0 0
Aarau
Country [50] 0 0
Switzerland
State/province [50] 0 0
Lausanne
Country [51] 0 0
Switzerland
State/province [51] 0 0
Zurich
Country [52] 0 0
United Kingdom
State/province [52] 0 0
Hull
Country [53] 0 0
United Kingdom
State/province [53] 0 0
Manchester
Country [54] 0 0
United Kingdom
State/province [54] 0 0
Portsmouth
Country [55] 0 0
United Kingdom
State/province [55] 0 0
Salford

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will evaluate the efficacy of SBR759 compared to sevelamer HCl in lowering serum
phosphate levels in Chronic Kidney Disease patients on hemodialysis
Trial website
https://clinicaltrials.gov/ct2/show/NCT00704483
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis
Address 0 0
Novartis
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00704483