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

A Double-blind, Randomized, Placebo-controlled Multi-center Trial to Compare the Phosphate Lowering Efficacy of Different Doses of SBR759 to Placebo

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

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease; Hyperphosphatemia
• Intervention / Treatment: Drug: SBR759A; Drug: SBR759A; Drug: SBR759A; Drug: SBR759A; Drug: SBR759A

• Study Type: Interventional
• Enrollment (Actual): 115
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluate the change from baseline in 72-hour serum phosphate levels of 4 different doses of SBR759 versus placebo over 4 weeks of treatment	6 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Evaluate changes in serum phosphate during a 2 week random treatment withdrawal period of SBR759 after 4 weeks treatment	6 weeks
Evaluate dose-dependent efficacy of SBR759	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	6 weeks

Collaborators and Investigators

• Sponsor: Novartis

Publications and helpful links

General Publications

• 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.

Helpful Links

• Results for CSBR759A2304 from the Novartis Clinical Trials website

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: February 15, 2010
• First Submitted That Met QC Criteria: February 16, 2010
• First Posted (Estimate): February 17, 2010

Study Record Updates

• Last Update Posted (Actual): December 19, 2020
• Last Update Submitted That Met QC Criteria: December 11, 2020
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: Chronic Kidney Disease; Hemodialysis; Hyperphosphatemia; Hyperphosphatemia patients with chronic kidney disease on 3x/week hemodialysis
• Additional Relevant MeSH Terms: Metabolic Diseases; Urologic Diseases; Renal Insufficiency; Phosphorus Metabolism Disorders; Kidney Diseases; Renal Insufficiency, Chronic; Hyperphosphatemia; Hematinics; Ferric Compounds
• Other Study ID Numbers: CSBR759A2304; 2008-006097-15 (EudraCT Number)