Clinical trial NCT00704678: Optimal Titration Regimen for SBR759 in Lowering Serum Phosphate Levels in Asian Chronic Kidney Disease Patients on Hemodialysis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Kidney Disease
Keywords: Chronic Kidney Disease
hemodialysis
hyperphosphatemia
Asian
patients
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-06-25
Enrollment: 203
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Responder rates achieving target serum phosphate levels.
timeFrame: Week 12
Secondary outcomes:
measure: Responder rates in target patients with serum calcium-phosphate levels.
timeFrame: Week 12
Other outcomes:
Locations:
city: Koriyama
country: Japan
facility: Novartis Investigative Site
state: Fukushima
city: Midori
country: Japan
facility: Novartis Investigative Site
state: Gunma
city: Hitachiomiya
country: Japan
facility: Novartis Investigative Site
state: Ibaraki
city: Moriya
country: Japan
facility: Novartis Investigative Site
state: Ibaraki
city: Sashima-gun
country: Japan
facility: Novartis Investigative Site
state: Ibaraki
city: Takamatsu
country: Japan
facility: Novartis Investigative Site
state: Kagawa
city: Tsu
country: Japan
facility: Novartis Investigative Site
state: Mie
city: Okayama City
country: Japan
facility: Novartis Investigative Site
state: Okayama
city: Sakai
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Kasukabe
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Nagano
country: Japan
facility: Novartis Investigative Site
city: Shizuoka
country: Japan
facility: Novartis Investigative Site
city: Changhua
country: Taiwan
facility: Novartis Investigative Site
city: Kaoshiung
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Chen JB, Chiang SS, Chen HC, Obayashi S, Nagasawa M, Hexham JM, Balfour A, Junge G, Akiba T, Fukagawa M. Efficacy and safety of SBR759, a novel calcium-free, iron(III)-based phosphate binder, in Asian patients undergoing hemodialysis: A 12-week, randomized, open-label, dose-titration study versus sevelamer hydrochloride. Nephrology (Carlton). 2011 Nov;16(8):743-50. doi: 10.1111/j.1440-1797.2011.01509.x.