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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01069692
Recruitment Status : Completed
First Posted : February 17, 2010
Last Update Posted : July 21, 2011
Information provided by:

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 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
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
Drug: SBR759A
9g daily
Experimental: arm 5 Drug: SBR759A
12g daily

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 ]

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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:

  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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01069692

Novartis Investigative Site
Jette, Belgium, 1090
Novartis Investigative Site
Liege, Belgium, 4000
Novartis Investigative Site
Roeselare, Belgium, 8800
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
Study Director: Novartis Pharmceuticals Novartis Pharmaceuticals

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: External Affairs, Novartis Pharmaceuticals 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
Hyperphosphatemia patients with chronic kidney disease on 3x/week hemodialysis

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Phosphorus Metabolism Disorders
Metabolic Diseases
Ferric Compounds