Optimal Titration Regimen for SBR759 in Lowering Serum Phosphate Levels in Asian Chronic Kidney Disease Patients on Hemodialysis (SBR759)

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ClinicalTrials.gov Identifier: NCT00704678

Recruitment Status : Completed

First Posted : June 25, 2008

Last Update Posted : September 23, 2016

Sponsor:

Information provided by (Responsible Party):

Novartis ( Novartis Pharmaceuticals )

Study Description

Brief Summary:

This study will determine the titration regimen for SBR759 compared to sevelamer HCl in lowering serum phosphate levels in Asian Chronic Kidney Disease patients on hemodialysis

Condition or disease	Intervention/treatment	Phase
Chronic Kidney Disease	Drug: SBR759 Drug: Sevelamer HCl	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	203 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A 12-week, Open Label, Multicenter, Titration Study, With a 12 Month Extension, to Determine the Optimal Titration Regimen for SBR759, Compared to Sevelamer HCl, in Lowering Serum Phosphate Levels in Asian Patients With Chronic Kidney Disease on Hemodialysis
Study Start Date :	August 2008
Actual Primary Completion Date :	June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis Kidney Diseases

Drug Information available for: Sevelamer

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1 1g bid	Drug: SBR759 1g tid
Active Comparator: 2 0.8 g tid	Drug: Sevelamer HCl 0.8 g tid
Experimental: 3 1.5 g tid	Drug: Sevelamer HCl 1.5 g tid
Active Comparator: 4 1.6 g tid	Drug: Sevelamer HCl 1.6 g tid

Outcome Measures

Primary Outcome Measures :

Responder rates achieving target serum phosphate levels. [ Time Frame: Week 12 ]

Secondary Outcome Measures :

Responder rates in target patients with serum calcium-phosphate levels. [ Time Frame: Week 12 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria

Men or women of at least 18 years old or 20 years old in Japan.
Stable maintenance of hemodialysis 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 or a non-conventional hemodialysis technique .
Parathyroidectomy or transplant scheduled during the study.
Uncontrolled hyperparathyroidism
History of hemochromatosis or ferritin > 800 µg/L.
Clinically significant GI disorder
Unstable medical condition other than Chronic Kidney Disease.
Treated with sevelamer HCl monotherapy or SBR759.
Treated with oral iron.
Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00704678

Locations

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Japan
Novartis Investigative Site
Koriyama, Fukushima, Japan
Novartis Investigative Site
Midori, Gunma, Japan
Novartis Investigative Site
Hitachiomiya, Ibaraki, Japan
Novartis Investigative Site
Moriya, Ibaraki, Japan
Novartis Investigative Site
Sashima-gun, Ibaraki, Japan
Novartis Investigative Site
Takamatsu, Kagawa, Japan
Novartis Investigative Site
Tsu, Mie, Japan
Novartis Investigative Site
Okayama City, Okayama, Japan
Novartis Investigative Site
Sakai, Osaka, Japan
Novartis Investigative Site
Kasukabe, Saitama, Japan
Novartis Investigative Site
Nagano, Japan
Novartis Investigative Site
Shizuoka, Japan
Taiwan
Novartis Investigative Site
Changhua, Taiwan
Novartis Investigative Site
Kaoshiung, Taiwan
Novartis Investigative Site
Taipei, Taiwan

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

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Study Director:	Novartis Pharmaceuticals	Novartis Pharmaceuticals

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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Responsible Party:	Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00704678 History of Changes
Other Study ID Numbers:	CSBR759A2202
First Posted:	June 25, 2008 Key Record Dates
Last Update Posted:	September 23, 2016
Last Verified:	September 2016

Keywords provided by Novartis ( Novartis Pharmaceuticals ):


Chronic Kidney Disease hemodialysis hyperphosphatemia Asian patients

Additional relevant MeSH terms:

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Kidney Diseases Renal Insufficiency, Chronic Urologic Diseases Renal Insufficiency	Sevelamer Chelating Agents Sequestering Agents Molecular Mechanisms of Pharmacological Action

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