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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
History of Changes

June 23, 2008
July 20, 2011
August 2008
June 2010   (final data collection date for primary outcome measure)
Responder rates achieving target serum phosphate levels. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Responder rates achieving target serum phosphate levels at 12 weeks. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00704678 on ClinicalTrials.gov Archive Site
Responder rates in target patients with serum calcium-phosphate levels. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Responder rates in target patients with serum calcium-phosphate levels at 12 weeks/12 [ Time Frame: 12 weeks and 15 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Optimal Titration Regimen for SBR759 in Lowering Serum Phosphate Levels in Asian Chronic Kidney Disease Patients on Hemodialysis
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

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
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Kidney Disease
  • Drug: SBR759
    1g tid
  • Drug: Sevelamer HCl
    1.6 g tid
  • Drug: Sevelamer HCl
    1.5 g tid
  • Drug: Sevelamer HCl
    0.8 g tid
  • Experimental: 1
    1g bid
    Intervention: Drug: SBR759
  • Active Comparator: 2
    0.8 g tid
    Intervention: Drug: Sevelamer HCl
  • Experimental: 3
    1.5 g tid
    Intervention: Drug: Sevelamer HCl
  • Active Comparator: 4
    1.6 g tid
    Intervention: Drug: Sevelamer HCl
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
203
Not Provided
June 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan,   Taiwan
 
NCT00704678
CSBR759A2202
Not Provided
External Affairs, Novartis Pharmaceuticals
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP