Optimal Titration Regimen for SBR759 in Lowering Serum Phosphate Levels in Asian Chronic Kidney Disease Patients on Hemodialysis (SBR759)
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00704678
First received: June 23, 2008
Last updated: September 22, 2016
Last verified: September 2016
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Kidney Disease |
Drug: SBR759 Drug: Sevelamer HCl |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Responder rates achieving target serum phosphate levels. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Responder rates in target patients with serum calcium-phosphate levels. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
| Enrollment: | 203 |
| Study Start Date: | August 2008 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00704678
Please refer to this study by its ClinicalTrials.gov identifier: NCT00704678
Locations
| 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 | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
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 |
| Study First Received: | June 23, 2008 |
| Last Updated: | September 22, 2016 |
| Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency Taiwan: Department of Health |
Keywords provided by Novartis:
|
Chronic Kidney Disease hemodialysis hyperphosphatemia Asian patients |
Additional relevant MeSH terms:
|
Kidney Diseases Renal Insufficiency, Chronic Urologic Diseases Renal Insufficiency |
Sevelamer Chelating Agents Sequestering Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on September 29, 2016