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

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00704483

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 II

MedlinePlus related topics: Dialysis Kidney Failure

Drug Information available for: Sevelamer Sevelamer carbonate Sevelamer hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

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 ]

Estimated Enrollment:	378
Study Start Date:	July 2008
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.
2: Active Comparator Sevelamer HCl	Drug: Sevelamer HCl 0.8 g tid
3: Experimental SBR759 1.5 g tid	Drug: SBR759 1.5 g tid
4: Active Comparator 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

Contacts

Contact: Novartis

862-778-8300

Show 66 Study Locations

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis

More Information

Responsible Party:	Novartis ( Novartis )
Study ID Numbers:	CSBR759A2201, EUDRACT No.: 2006-001787-23
Study First Received:	June 23, 2008
Last Updated:	December 1, 2008
ClinicalTrials.gov Identifier:	NCT00704483
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: National Agency for Medicines; France: Afssaps - French Health Products Safety Agency; Italy: National Institute of Health; Norway: Directorate for Health and Social Affairs; Sweden: Medical Products Agency; Switzerland: Swissmedic; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:

Chronic Kidney Disease
hemodialysis
hyperphosphatemia
hemodiafiltration

Study placed in the following topic categories:

Sevelamer
Renal Insufficiency
Metabolic Diseases
Urologic Diseases
Renal Insufficiency, Chronic

Kidney Failure, Chronic
Hyperphosphatemia
Kidney Diseases
Metabolic disorder
Kidney Failure

Additional relevant MeSH terms:

Phosphorus Metabolism Disorders
Molecular Mechanisms of Pharmacological Action
Chelating Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009