Efficacy of SBR759 in Lowering Serum Phosphate Levels in Chronic Kidney Disease Patients on Hemodialysis - Full Text View

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:

MedlinePlus related topics: Chronic Kidney Disease Dialysis

Drug Information available for: Phosphorus Sevelamer Sevelamer hydrochloride Sevelamer carbonate

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

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Locations

United States, California
Novartis
Chula Vista, California, United States, 91910
Novartis
La Mesa, California, United States, 91942
Novartis
Whittier, California, United States, 90602
United States, Colorado
Novartis
Denver, Colorado, United States, 80262
United States, Illinois
Novartis
North Chicago, Illinois, United States, 60064
Novartis
Peoria, Illinois, United States, 61602
United States, Indiana
Novartis
Mishawaka, Indiana, United States, 46545
United States, Maryland
Novartis
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Novartis
Fall River, Massachusetts, United States, 02720
Novartis
Springfield, Massachusetts, United States, 01104
United States, Nebraska
Novartis Investigative Site
Omaha, Nebraska, United States, 68144
United States, New York
Novartis
New York, New York, United States, 10032
United States, North Carolina
Novartis
Winston Salem, North Carolina, United States, 27157-1082
United States, North Dakota
Novarits
Fargo, North Dakota, United States, 58103
United States, Oregon
Novartis
Portland, Oregon, United States, 97210
United States, Pennsylvania
Novartis
Pittsburgh, Pennsylvania, United States, 15224
United States, Texas
Novartis Investigative Site
Houston, Texas, United States, 77024
Novartis
San Antonio, Texas, United States, 78207
United States, Virginia
Novartis
Fairfax, Virginia, United States, 22031
Australia, South Australia
Novartis
Adelaide, South Australia, Australia
Australia, Victoria
Novartis
Fitzroy, Victoria, Australia
Novartis
Parkville, Victoria, Australia, 3052
Australia
Novartis
Melbourne, Australia, 3065
Novartis
South Brisbane, Australia
Novartis
Woolloongabba, Australia, 4102
Belgium
Novartis Investigative Site
Antwerpen, Belgium
Novartis
Brugge, Belgium, 8000
Novartis
Bruxelles, Belgium, 1000
Novartis
Liege, Belgium, 4000
Novartis Investigative Site
St. Niklaas, Belgium
Canada
Novartis Investigative Site
Edmonton, Canada
Novartis Investigative Site
London, Canada
Novartis Investigative Site
Oshawa, Canada
Novartis Investigative Site
Quebec, Canada
Finland
Novartis
Helsinki, Finland, 00100
Novartis
Oulu, Finland, 90100
Novartis
Tampere, Finland, 33100
Novartis
Turku, Finland, 20100
France
Novartis
Amiens, France, 80054
Novartis
Fleury Merogis, France
Novartis
Lyon Cedex, France, 69446
Novartis
Rheims Cedex, France, 51685
Novartis
Salouel, France, 80480
Germany
Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Coburg, Germany
Italy
Novartis Investigative Site
Lecco, Italy
Novartis Investigative Site
Lodi, Italy
Novartis Investigative Site
Milano, Italy
Novartis Investigative Site
Modena, Italy
Novartis Investigative Site
Pavia, Italy
Norway
Novartis
Bergen, Norway, 5011
Novartis
Kristiansand, Norway, 1001
Novartis
Oslo, Norway, 0027
Novartis
Tonsberg, Norway
Puerto Rico
Novartis
San Juan, Puerto Rico, 00927
Sweden
Novartis Investigative Site
Jonkoping, Sweden
Novartis Investigative Site
Karlstad, Sweden
Novartis Investigative Site
Skovde, Sweden
Novartis Investigative Site
Stockholm, Sweden
Switzerland
Novartis
Aarau, Switzerland, 5000
Novartis
Lausanne, Switzerland, 1011
Novartis
Zurich, Switzerland, 8091
United Kingdom
Novartis
Hull, United Kingdom
Novartis Investigative Site
Manchester, United Kingdom
Novartis Investigative Site
Portsmouth, United Kingdom
Novartis
Salford, United Kingdom

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

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 19, 2013