Placebo Versus SBR759 in Lowering Phosphate in Dialysis Patients (SBR759)
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ClinicalTrials.gov Identifier: NCT01069692 |
Recruitment Status
:
Completed
First Posted
: February 17, 2010
Last Update Posted
: July 21, 2011
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hyperphosphatemia Chronic Kidney Disease | Drug: SBR759A | Phase 3 |
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 |
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
|
- 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 ]
- Evaluate changes in serum phosphate during a 2 week random treatment withdrawal period of SBR759 after 4 weeks treatment [ Time Frame: 6 weeks ]
- Evaluate dose-dependent efficacy of SBR759 [ Time Frame: 6 weeks ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
- Men or women of at least 18 years of age
- Stable maintenance of hemodialysis 3 times per week for 3 months or greater
- Controlled serum phosphate if under phosphate-binder therapy
- 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:
- Patients who are on peritoneal dialysis
- Patients who have a transplant or parathyroidectomy scheduled during the study
- Clinically significant GI disorder
- Unstable medical condition other than Chronic Kidney Disease
- Patient is currently being treated with oral iron
- History of hemachromatosis, or ferritin > 1000 ng/mL
- Transferrin saturation > 60%
- Uncontrolled hyperparathyroidism (iPTH > 84.8 pmol/L) Other protocol-defined inclusion/exclusion criteria may apply

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): NCT01069692
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 |
Study Director: | Novartis Pharmceuticals | Novartis Pharmaceuticals |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 Key Record Dates |
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 |