Optimal Titration Regimen for SBR759 in Lowering Serum Phosphate Levels in Asian Chronic Kidney Disease Patients on Hemodialysis

Chronic Kidney Disease Clinical Trial

— SBR759  

Official title:

A 12-week, Open Label, Multicenter, Titration Study, With a 12 Month Extension, to Determine the Optimal Titration Regimen for SBR759, Compared to Sevelamer HCl, in Lowering Serum Phosphate Levels in Asian Patients With Chronic Kidney Disease on Hemodialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00704678
• Other study ID #: CSBR759A2202
• Status: Completed
• Phase: Phase 2
• First received: June 23, 2008
• Last updated: September 22, 2016
• Start date: August 2008

Study information

• Verified date: September 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices AgencyTaiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

This study will determine the titration regimen for SBR759 compared to sevelamer HCl in lowering serum phosphate levels in Asian Chronic Kidney Disease patients on hemodialysis

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria

• Men or women of at least 18 years old or 20 years old in Japan.

• Stable maintenance of hemodialysis 3 times per week.

• Controlled serum phosphate if under phosphate-binder therapy.

• Serum phosphate level > 6.0 mg/dL (> 1.9 mmol/L) prior to study treatment initiation.

Exclusion criteria

• Peritoneal dialysis or a non-conventional hemodialysis technique .

• Parathyroidectomy or transplant scheduled during the study.

• Uncontrolled hyperparathyroidism

• History of hemochromatosis or ferritin > 800 µg/L.

• Clinically significant GI disorder

• Unstable medical condition other than Chronic Kidney Disease.

• Treated with sevelamer HCl monotherapy or SBR759.

• Treated with oral iron.

• Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• SBR759
1g tid
• Sevelamer HCl
1.6 g tid
• Sevelamer HCl
1.5 g tid
• Sevelamer HCl
0.8 g tid

Locations

Country	Name	City	State
Japan	Novartis Investigative Site	Hitachiomiya	Ibaraki
Japan	Novartis Investigative Site	Kasukabe	Saitama
Japan	Novartis Investigative Site	Koriyama	Fukushima
Japan	Novartis Investigative Site	Midori	Gunma
Japan	Novartis Investigative Site	Moriya	Ibaraki
Japan	Novartis Investigative Site	Nagano
Japan	Novartis Investigative Site	Okayama City	Okayama
Japan	Novartis Investigative Site	Sakai	Osaka
Japan	Novartis Investigative Site	Sashima-gun	Ibaraki
Japan	Novartis Investigative Site	Shizuoka
Japan	Novartis Investigative Site	Takamatsu	Kagawa
Japan	Novartis Investigative Site	Tsu	Mie
Taiwan	Novartis Investigative Site	Changhua
Taiwan	Novartis Investigative Site	Kaoshiung
Taiwan	Novartis Investigative Site	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Japan,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Responder rates achieving target serum phosphate levels.		Week 12	No
Secondary	Responder rates in target patients with serum calcium-phosphate levels.		Week 12	No