Clinical trial NCT00704483: Efficacy of SBR759 in Lowering Serum Phosphate Levels in Chronic Kidney Disease Patients on Hemodialysis
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hyperphosphatemia Patients With Chronic Kidney Disease on 3x/Week Replacement Therapy
Keywords: Chronic Kidney Disease
hemodialysis
hyperphosphatemia
hemodiafiltration
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-06-25
Enrollment: 321
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

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.

Primary outcomes:
measure: Responder rates in target serum phosphate levels at 12 weeks Evaluate efficacy of SBR759 compared to sevelamer HCl at 12 weeks
timeFrame: Time Frame: 12 weeks + 12 months
Secondary outcomes:
measure: Responder rates in target patients with serum calcium-phosphate levels at 12 weeks/12 months
timeFrame: Time Frame: 12 weeks / 12 months
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: Novartis
state: California
city: La Mesa
country: United States
facility: Novartis
state: California
city: Whittier
country: United States
facility: Novartis
state: California
city: Denver
country: United States
facility: Novartis
state: Colorado
city: North Chicago
country: United States
facility: Novartis
state: Illinois
city: Peoria
country: United States
facility: Novartis
state: Illinois
city: Mishawaka
country: United States
facility: Novartis
state: Indiana
city: Baltimore
country: United States
facility: Novartis
state: Maryland
city: Fall River
country: United States
facility: Novartis
state: Massachusetts
city: Springfield
country: United States
facility: Novartis
state: Massachusetts
city: Omaha
country: United States
facility: Novartis Investigative Site
state: Nebraska
city: New York
country: United States
facility: Novartis
state: New York
city: Winston-Salem
country: United States
facility: Novartis
state: North Carolina
city: Fargo
country: United States
facility: Novarits
state: North Dakota
city: Portland
country: United States
facility: Novartis
state: Oregon
city: Pittsburgh
country: United States
facility: Novartis
state: Pennsylvania
city: Houston
country: United States
facility: Novartis Investigative Site
state: Texas
city: San Antonio
country: United States
facility: Novartis
state: Texas
city: Fairfax
country: United States
facility: Novartis
state: Virginia
city: Adelaide
country: Australia
facility: Novartis
state: South Australia
city: Fitzroy
country: Australia
facility: Novartis
state: Victoria
city: Parkville
country: Australia
facility: Novartis
state: Victoria
city: Melbourne
country: Australia
facility: Novartis
city: South Brisbane
country: Australia
facility: Novartis
city: Woolloongabba
country: Australia
facility: Novartis
city: Antwerpen
country: Belgium
facility: Novartis Investigative Site
city: Brugge
country: Belgium
facility: Novartis
city: Bruxelles
country: Belgium
facility: Novartis
city: Liege
country: Belgium
facility: Novartis
city: Saint Niklaas
country: Belgium
facility: Novartis Investigative Site
city: Edmonton
country: Canada
facility: Novartis Investigative Site
city: London
country: Canada
facility: Novartis Investigative Site
city: Oshawa
country: Canada
facility: Novartis Investigative Site
city: Quebec
country: Canada
facility: Novartis Investigative Site
city: Helsinki
country: Finland
facility: Novartis
city: Oulu
country: Finland
facility: Novartis
city: Tampere
country: Finland
facility: Novartis
city: Turku
country: Finland
facility: Novartis
city: Amiens
country: France
facility: Novartis
city: Fleury Merogis
country: France
facility: Novartis
city: Lyon Cedex
country: France
facility: Novartis
city: Rheims Cedex
country: France
facility: Novartis
city: Salouel
country: France
facility: Novartis
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Coburg
country: Germany
facility: Novartis Investigative Site
city: Lecco
country: Italy
facility: Novartis Investigative Site
city: Lodi
country: Italy
facility: Novartis Investigative Site
city: Milano
country: Italy
facility: Novartis Investigative Site
city: Modena
country: Italy
facility: Novartis Investigative Site
city: Pavia
country: Italy
facility: Novartis Investigative Site
city: Bergen
country: Norway
facility: Novartis
city: Kristiansand
country: Norway
facility: Novartis
city: Oslo
country: Norway
facility: Novartis
city: Tonsberg
country: Norway
facility: Novartis
city: San Juan
country: Puerto Rico
facility: Novartis
city: Jonkoping
country: Sweden
facility: Novartis Investigative Site
city: Karlstad
country: Sweden
facility: Novartis Investigative Site
city: Skovde
country: Sweden
facility: Novartis Investigative Site
city: Stockholm
country: Sweden
facility: Novartis Investigative Site
city: Aarau
country: Switzerland
facility: Novartis
city: Lausanne
country: Switzerland
facility: Novartis
city: Zurich
country: Switzerland
facility: Novartis
city: Hull
country: United Kingdom
facility: Novartis
city: Manchester
country: United Kingdom
facility: Novartis Investigative Site
city: Portsmouth
country: United Kingdom
facility: Novartis Investigative Site
city: Salford
country: United Kingdom
facility: Novartis
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References:
citation: Chen JB, Chiang SS, Chen HC, Obayashi S, Nagasawa M, Hexham JM, Balfour A, Junge G, Akiba T, Fukagawa M. Efficacy and safety of SBR759, a novel calcium-free, iron(III)-based phosphate binder, in Asian patients undergoing hemodialysis: A 12-week, randomized, open-label, dose-titration study versus sevelamer hydrochloride. Nephrology (Carlton). 2011 Nov;16(8):743-50. doi: 10.1111/j.1440-1797.2011.01509.x.