Placebo Versus SBR759 in Lowering Phosphate in Dialysis Patients

Chronic Kidney Disease Clinical Trial

— SBR759  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01069692
• Other study ID #: CSBR759A2304
• Secondary ID: 2008-006097-15
• Status: Completed
• Phase: Phase 3
• Start date: February 2010

Study information

• Verified date: July 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Hyperphosphatemia
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• SBR759A
SBR759A 6g daily
• SBR759A
Placebo Comparator 0g daily
• SBR759A
SBR759A 3g daily
• SBR759A
9g daily
• SBR759A
12g daily

Locations

Country	Name	City	State
Belgium	Novartis Investigative Site	Jette
Belgium	Novartis Investigative Site	Liege
Belgium	Novartis Investigative Site	Roeselare
Italy	Novartis Investigative Site	Brescia
Italy	Novartis Investigative Site	Lecco
Italy	Novartis Investigator Site	Lucca
Italy	Novartis Investigative Site	Napoli
Italy	Novartis Investigative Site	Pavia
Italy	Novartis Investigative Site	Siena

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Countries where clinical trial is conducted

Belgium,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluate changes in serum phosphate during a 2 week random treatment withdrawal period of SBR759 after 4 weeks treatment		6 weeks
Secondary	Evaluate dose-dependent efficacy of SBR759		6 weeks
Secondary	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

External Links

•   Results for CSBR759A2304 from the Novartis Clinical Trials website