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

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ClinicalTrials.gov Identifier: NCT00704678
Recruitment Status : Completed
First Posted : June 25, 2008
Last Update Posted : September 23, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE June 23, 2008
First Posted Date  ICMJE June 25, 2008
Last Update Posted Date September 23, 2016
Study Start Date  ICMJE August 2008
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 29, 2009)
Responder rates achieving target serum phosphate levels. [ Time Frame: Week 12 ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 24, 2008)
Responder rates achieving target serum phosphate levels at 12 weeks. [ Time Frame: 12 weeks ]
Change History Complete list of historical versions of study NCT00704678 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2009)
Responder rates in target patients with serum calcium-phosphate levels. [ Time Frame: Week 12 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2008)
Responder rates in target patients with serum calcium-phosphate levels at 12 weeks/12 [ Time Frame: 12 weeks and 15 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Optimal Titration Regimen for SBR759 in Lowering Serum Phosphate Levels in Asian Chronic Kidney Disease Patients on Hemodialysis
Official Title  ICMJE 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
Brief Summary 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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Kidney Disease
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * 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. doi: 10.1111/j.1440-1797.2011.01509.x.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 29, 2009)
203
Original Estimated Enrollment  ICMJE
 (submitted: June 24, 2008)
200
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan,   Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00704678
Other Study ID Numbers  ICMJE CSBR759A2202
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date September 2016

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