Optimal Titration Regimen for SBR759 in Lowering Serum Phosphate Levels in Asian Chronic Kidney Disease Patients on Hemodialysis - Full Text View

Purpose

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	Intervention	Phase
Chronic Kidney Disease	Drug: SBR759 Drug: Sevelamer HCl	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Chronic Kidney Disease Dialysis Kidney Diseases

Drug Information available for: Sevelamer Sevelamer hydrochloride Sevelamer carbonate

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Responder rates achieving target serum phosphate levels. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Responder rates in target patients with serum calcium-phosphate levels. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]


Enrollment:	203
Study Start Date:	August 2008
Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00704678

Locations


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


Study Director:	Novartis Pharmaceuticals	Novartis Pharmaceuticals

More Information

No publications provided by Novartis

Additional 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.


Responsible Party:	External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00704678 History of Changes
Other Study ID Numbers:	CSBR759A2202
Study First Received:	June 23, 2008
Last Updated:	July 20, 2011
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency Taiwan: Department of Health

Keywords provided by Novartis:


Chronic Kidney Disease hemodialysis hyperphosphatemia Asian patients

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on February 27, 2015