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

This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: June 23, 2008
Last updated: September 22, 2016
Last verified: September 2016
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:

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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00704678

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
Novartis Investigative Site
Changhua, Taiwan
Novartis Investigative Site
Kaoshiung, Taiwan
Novartis Investigative Site
Taipei, Taiwan
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Novartis Pharmaceuticals Identifier: NCT00704678     History of Changes
Other Study ID Numbers: CSBR759A2202 
Study First Received: June 23, 2008
Last Updated: September 22, 2016
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency
Taiwan: Department of Health

Keywords provided by Novartis:
Chronic Kidney Disease

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action processed this record on October 21, 2016