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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00704678
First Posted: June 25, 2008
Last Update Posted: September 23, 2016
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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  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
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

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00704678     History of Changes
Other Study ID Numbers: CSBR759A2202
First Submitted: June 23, 2008
First Posted: June 25, 2008
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:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Sevelamer
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action