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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
  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
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 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:

U.S. FDA Resources

Further study details as provided by Novartis:

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]

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

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.
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00704483

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

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00704483     History of Changes
Other Study ID Numbers: CSBR759A2201, EUDRACT No.: 2006-001787-23
Study First Received: June 23, 2008
Last Updated: November 3, 2011
Health Authority: United States: Food and Drug Administration
European Union: European Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Ministry of Social Affairs, Public Health and the Environment
Canada: Health Canada
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Italy: National Institute of Health
Norway: Directorate of Health
Sweden: Medical Products Agency
Switzerland: Swissmedic
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:
Chronic Kidney Disease
hemodialysis
hyperphosphatemia
hemodiafiltration

Additional relevant MeSH terms:
Kidney Diseases
Hyperphosphatemia
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Phosphorus Metabolism Disorders
 Metabolic Diseases
Renal Insufficiency
Sevelamer
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013