Status:
COMPLETED
Optimal Titration Regimen for SBR759 in Lowering Serum Phosphate Levels in Asian Chronic Kidney Disease Patients on Hemodialysis
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Chronic Kidney Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
203 Patients enrolled
Trial Details
Trial ID
NCT00704678
Start Date
August 1 2008
Last Update
September 23 2016
Active Locations (15)
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1
Novartis Investigative Site
Kōriyama, Fukushima, Japan
2
Novartis Investigative Site
Midori, Gunma, Japan
3
Novartis Investigative Site
Hitachiomiya, Ibaraki, Japan
4
Novartis Investigative Site
Moriya, Ibaraki, Japan