Placebo Versus SBR759 in Lowering Phosphate in Dialysis Patients (SBR759)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

This study will compare placebo to 4 different doses of SBR759 to assess the phosphate lowering efficacy in dialysis patients.

Condition or disease	Intervention/treatment	Phase
Hyperphosphatemia; Chronic Kidney Disease	Drug: SBR759A	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	115 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	A Double-blind, Randomized, Placebo-controlled Multi-center Trial to Compare the Phosphate Lowering Efficacy of Different Doses of SBR759 to Placebo
Study Start Date :	February 2010
Actual Primary Completion Date :	October 2010

Arms and Interventions

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Arm	Intervention/treatment
Placebo Comparator: Arm 1; Placebo	Drug: SBR759A; Placebo Comparator 0g daily
Experimental: Arm 3	Drug: SBR759A; SBR759A 6g daily
Experimental: Arm 2	Drug: SBR759A; SBR759A 3g daily
Experimental: arm 4; SBR759A	Drug: SBR759A; 9g daily
Experimental: arm 5	Drug: SBR759A; 12g daily

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Evaluate the change from baseline in 72-hour serum phosphate levels of 4 different doses of SBR759 versus placebo over 4 weeks of treatment [ Time Frame: 6 weeks ]

Secondary Outcome Measures :

1. Evaluate changes in serum phosphate during a 2 week random treatment withdrawal period of SBR759 after 4 weeks treatment [ Time Frame: 6 weeks ]
2. Evaluate dose-dependent efficacy of SBR759 [ Time Frame: 6 weeks ]
3. Compare the short-term safety profile and dose-dependent tolerability of SBR759 dosed with meals taken 3 times a day to that of placebo [ Time Frame: 6 weeks ]

Eligibility Criteria

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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:

1. Men or women of at least 18 years of age
2. Stable maintenance of hemodialysis 3 times per week for 3 months or greater
3. Controlled serum phosphate if under phosphate-binder therapy
4. Patient must either be on a stable phosphate binder dose and are willing to stop their phosphate binder therapy at the beginning of the study, or not have received any phosphate binder therapy for at least 4 weeks prior to screening

Exclusion criteria:

1. Patients who are on peritoneal dialysis
2. Patients who have a transplant or parathyroidectomy scheduled during the study
3. Clinically significant GI disorder
4. Unstable medical condition other than Chronic Kidney Disease
5. Patient is currently being treated with oral iron
6. History of hemachromatosis, or ferritin > 1000 ng/mL
7. Transferrin saturation > 60%
8. Uncontrolled hyperparathyroidism (iPTH > 84.8 pmol/L) Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Belgium
Novartis Investigative Site
Jette, Belgium, 1090
Novartis Investigative Site
Liege, Belgium, 4000
Novartis Investigative Site
Roeselare, Belgium, 8800
Italy
Novartis Investigative Site
Brescia, Italy, 25123
Novartis Investigative Site
Lecco, Italy, 23900
Novartis Investigator Site
Lucca, Italy, 55100
Novartis Investigative Site
Napoli, Italy, 80131
Novartis Investigative Site
Pavia, Italy, 27100
Novartis Investigative Site
Siena, Italy, 53100

Sponsors and Collaborators

Novartis

Investigators

Study Director:	Novartis Pharmceuticals	Novartis Pharmaceuticals

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Fukagawa M, Kasuga H, Joseph D, Sawata H, Junge G, Moore A, Akiba T. Efficacy and safety of SBR759, a novel calcium-free, iron (III)-based phosphate binder, versus placebo in chronic kidney disease stage V Japanese patients on maintenance renal replacement therapy. Clin Exp Nephrol. 2014 Feb;18(1):135-43. doi: 10.1007/s10157-013-0815-7. Epub 2013 May 15.

Responsible Party:	External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01069692 History of Changes
Other Study ID Numbers:	CSBR759A2304; 2008-006097-15 ( EudraCT Number )
First Posted:	February 17, 2010
Last Update Posted:	July 21, 2011
Last Verified:	July 2011

Keywords provided by Novartis:

Chronic Kidney Disease; Hemodialysis; Hyperphosphatemia; Hyperphosphatemia patients with chronic kidney disease on 3x/week hemodialysis

Additional relevant MeSH terms:

Kidney Diseases; Renal Insufficiency, Chronic; Hyperphosphatemia; Urologic Diseases; Renal Insufficiency	Phosphorus Metabolism Disorders; Metabolic Diseases; Ferric Compounds; Hematinics