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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00704678
First received: June 23, 2008
Last updated: July 20, 2011
Last verified: July 2011
  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:


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

ClinicalTrials.gov processed this record on July 22, 2014