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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00704483
First Posted: June 25, 2008
Last Update Posted: November 18, 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 evaluate the efficacy of SBR759 compared to sevelamer HCl in lowering serum phosphate levels in Chronic Kidney Disease patients on hemodialysis

Condition Intervention Phase
Hyperphosphatemia Patients With Chronic Kidney Disease on 3x/Week Replacement Therapy 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 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Responder rates in target patients with serum calcium-phosphate levels at 12 weeks/12 months [ Time Frame: Time Frame: 12 weeks / 12 months ]

Enrollment: 321
Study Start Date: July 2008
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
1g tid
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.
Active Comparator: 2
Sevelamer HCl
Drug: Sevelamer HCl
0.8 g tid
Experimental: 3
SBR759 1.5 g tid
Drug: SBR759
1.5 g tid
Active Comparator: 4
Sevelamer HCl
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.
  • 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.
  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): NCT00704483


  Show 66 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Novartis
  More Information

Additional Information:
Publications:
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00704483     History of Changes
Other Study ID Numbers: CSBR759A2201
EUDRACT No.: 2006-001787-23
First Submitted: June 23, 2008
First Posted: June 25, 2008
Last Update Posted: November 18, 2016
Last Verified: November 2016

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Chronic Kidney Disease
hemodialysis
hyperphosphatemia
hemodiafiltration

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Hyperphosphatemia
Urologic Diseases
Renal Insufficiency
Phosphorus Metabolism Disorders
Metabolic Diseases
Sevelamer
Ferric Compounds
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Hematinics