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Efficacy of SBR759 in Lowering Serum Phosphate Levels in Chronic Kidney Disease Patients on Hemodialysis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00704483
First received: June 23, 2008
Last updated: November 3, 2011
Last verified: November 2011
History of Changes

June 23, 2008
November 3, 2011
July 2008
August 2010   (final data collection date for primary outcome measure)
Responder rates in target serum phosphate levels at 12 weeks Evaluate efficacy of SBR759 compared to sevelamer HCl at 12 weeks [ Time Frame: Time Frame: 12 weeks + 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00704483 on ClinicalTrials.gov Archive Site
Responder rates in target patients with serum calcium-phosphate levels at 12 weeks/12 months [ Time Frame: Time Frame: 12 weeks / 12 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Efficacy of SBR759 in Lowering Serum Phosphate Levels in Chronic Kidney Disease Patients on Hemodialysis
A 12-week, Open Label, Multicenter, Titration Study, With a 9-month Maintenance Treatment Extension, to Demonstrate Efficacy of SBR759 Compared to Sevelamer HCl in Lowering Serum Phosphate Levels in Chronic Kidney Disease Patients on Hemodialysis

This study will evaluate the efficacy of SBR759 compared to sevelamer HCl in lowering serum phosphate levels in 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
Hyperphosphatemia Patients With Chronic Kidney Disease on 3x/Week Replacement Therapy
  • Drug: SBR759
    Starting dose of 1g or 1.5g tid, with an increase of 1g tid every 2 weeks until serum phosphate level fall below target.
  • Drug: Sevelamer HCl
    0.8 g tid
  • Drug: SBR759
    1.5 g tid
  • Drug: Sevelamer HCl
    1.6 g tid
  • Experimental: 1
    1g tid
    Intervention: Drug: SBR759
  • Active Comparator: 2
    Sevelamer HCl
    Intervention: Drug: Sevelamer HCl
  • Experimental: 3
    SBR759 1.5 g tid
    Intervention: Drug: SBR759
  • Active Comparator: 4
    Sevelamer HCl
    Intervention: Drug: Sevelamer HCl
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
321
Not Provided
August 2010   (final data collection date for primary outcome measure)

Inclusion criteria

  • Men or women of at least 18 years old.
  • Stable maintenance of renal replacement therapy 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.
  • Parathyroidectomy or transplant scheduled during the study.
  • Uncontrolled hyperparathyroidism
  • History of hemochromatosis or ferritin > 1000 µg/L.
  • Clinically significant GI disorder
  • Unstable medical condition other than Chronic Kidney Disease.
  • 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
United States,   Australia,   Belgium,   Canada,   Finland,   France,   Germany,   Italy,   Norway,   Puerto Rico,   Sweden,   Switzerland,   United Kingdom
 
NCT00704483
CSBR759A2201, EUDRACT No.: 2006-001787-23
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Novartis
Novartis
November 2011

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