Optimal Titration Regimen for SBR759 in Lowering Serum Phosphate Levels in Asian Chronic Kidney Disease Patients on Hemodialysis (SBR759)
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ClinicalTrials.gov Identifier: NCT00704678 |
Recruitment Status :
Completed
First Posted : June 25, 2008
Last Update Posted : September 23, 2016
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Kidney Disease | Drug: SBR759 Drug: Sevelamer HCl | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 203 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 Start Date : | August 2008 |
Actual Primary Completion Date : | June 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
1g bid
|
Drug: SBR759
1g tid |
Active Comparator: 2
0.8 g tid
|
Drug: Sevelamer HCl
0.8 g tid |
Experimental: 3
1.5 g tid
|
Drug: Sevelamer HCl
1.5 g tid |
Active Comparator: 4
1.6 g tid
|
Drug: Sevelamer HCl
1.6 g tid |
- Responder rates achieving target serum phosphate levels. [ Time Frame: Week 12 ]
- Responder rates in target patients with serum calcium-phosphate levels. [ Time Frame: Week 12 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00704678
Japan | |
Novartis Investigative Site | |
Koriyama, Fukushima, Japan | |
Novartis Investigative Site | |
Midori, Gunma, Japan | |
Novartis Investigative Site | |
Hitachiomiya, Ibaraki, Japan | |
Novartis Investigative Site | |
Moriya, Ibaraki, Japan | |
Novartis Investigative Site | |
Sashima-gun, Ibaraki, Japan | |
Novartis Investigative Site | |
Takamatsu, Kagawa, Japan | |
Novartis Investigative Site | |
Tsu, Mie, Japan | |
Novartis Investigative Site | |
Okayama City, Okayama, Japan | |
Novartis Investigative Site | |
Sakai, Osaka, Japan | |
Novartis Investigative Site | |
Kasukabe, Saitama, Japan | |
Novartis Investigative Site | |
Nagano, Japan | |
Novartis Investigative Site | |
Shizuoka, Japan | |
Taiwan | |
Novartis Investigative Site | |
Changhua, Taiwan | |
Novartis Investigative Site | |
Kaoshiung, Taiwan | |
Novartis Investigative Site | |
Taipei, Taiwan |
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Novartis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00704678 History of Changes |
Other Study ID Numbers: |
CSBR759A2202 |
First Posted: | June 25, 2008 Key Record Dates |
Last Update Posted: | September 23, 2016 |
Last Verified: | September 2016 |
Chronic Kidney Disease hemodialysis hyperphosphatemia Asian patients |
Kidney Diseases Renal Insufficiency, Chronic Urologic Diseases Renal Insufficiency |
Sevelamer Chelating Agents Sequestering Agents Molecular Mechanisms of Pharmacological Action |