Placebo Versus SBR759 in Lowering Phosphate in Dialysis Patients (SBR759)
This study has been completed.
Sponsor:
Novartis
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT01069692
First received: February 15, 2010
Last updated: July 20, 2011
Last verified: July 2011
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Purpose
This study will compare placebo to 4 different doses of SBR759 to assess the phosphate lowering efficacy in dialysis patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Hyperphosphatemia Chronic Kidney Disease |
Drug: SBR759A |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Double-blind, Randomized, Placebo-controlled Multi-center Trial to Compare the Phosphate Lowering Efficacy of Different Doses of SBR759 to Placebo |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Evaluate the change from baseline in 72-hour serum phosphate levels of 4 different doses of SBR759 versus placebo over 4 weeks of treatment [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Evaluate changes in serum phosphate during a 2 week random treatment withdrawal period of SBR759 after 4 weeks treatment [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Evaluate dose-dependent efficacy of SBR759 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Compare the short-term safety profile and dose-dependent tolerability of SBR759 dosed with meals taken 3 times a day to that of placebo [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 115 |
| Study Start Date: | February 2010 |
| Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Arm 1
Placebo
|
Drug: SBR759A
Placebo Comparator 0g daily
|
| Experimental: Arm 3 |
Drug: SBR759A
SBR759A 6g daily
|
| Experimental: Arm 2 |
Drug: SBR759A
SBR759A 3g daily
|
|
Experimental: arm 4
SBR759A
|
Drug: SBR759A
9g daily
|
| Experimental: arm 5 |
Drug: SBR759A
12g daily
|
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 of age
- Stable maintenance of hemodialysis 3 times per week for 3 months or greater
- Controlled serum phosphate if under phosphate-binder therapy
- Patient must either be on a stable phosphate binder dose and are willing to stop their phosphate binder therapy at the beginning of the study, or not have received any phosphate binder therapy for at least 4 weeks prior to screening
Exclusion criteria:
- Patients who are on peritoneal dialysis
- Patients who have a transplant or parathyroidectomy scheduled during the study
- Clinically significant GI disorder
- Unstable medical condition other than Chronic Kidney Disease
- Patient is currently being treated with oral iron
- History of hemachromatosis, or ferritin > 1000 ng/mL
- Transferrin saturation > 60%
- Uncontrolled hyperparathyroidism (iPTH > 84.8 pmol/L) Other protocol-defined inclusion/exclusion criteria may apply
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01069692
Please refer to this study by its ClinicalTrials.gov identifier: NCT01069692
Locations
| Belgium | |
| Novartis Investigative Site | |
| Jette, Belgium, 1090 | |
| Novartis Investigative Site | |
| Liege, Belgium, 4000 | |
| Novartis Investigative Site | |
| Roeselare, Belgium, 8800 | |
| Italy | |
| Novartis Investigative Site | |
| Brescia, Italy, 25123 | |
| Novartis Investigative Site | |
| Lecco, Italy, 23900 | |
| Novartis Investigator Site | |
| Lucca, Italy, 55100 | |
| Novartis Investigative Site | |
| Napoli, Italy, 80131 | |
| Novartis Investigative Site | |
| Pavia, Italy, 27100 | |
| Novartis Investigative Site | |
| Siena, Italy, 53100 | |
Sponsors and Collaborators
Novartis
Investigators
| Study Director: | Novartis Pharmceuticals | Novartis Pharmaceuticals |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | External Affairs, Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01069692 History of Changes |
| Other Study ID Numbers: | CSBR759A2304 2008-006097-15 |
| Study First Received: | February 15, 2010 |
| Last Updated: | July 20, 2011 |
| Health Authority: | United States: Food and Drug Administration European Union: European Medicines Agency Belgium: Ministry of Social Affairs, Public Health and the Environment Czech Republic: State Institute for Drug Control Hungary: National Institute of Pharmacy Italy: Ministry of Health Turkey: Ministry of Health Japan: Pharmaceuticals and Medical Devices Agency India: Drugs Controller General of India Russia: Ministry of Health of the Russian Federation Ukraine: State Pharmacological Center - Ministry of Health |
Keywords provided by Novartis:
|
Chronic Kidney Disease Hemodialysis Hyperphosphatemia Hyperphosphatemia patients with chronic kidney disease on 3x/week hemodialysis |
Additional relevant MeSH terms:
|
Kidney Diseases Renal Insufficiency, Chronic Hyperphosphatemia Urologic Diseases Renal Insufficiency |
Phosphorus Metabolism Disorders Metabolic Diseases Ferric Compounds Hematinics |
ClinicalTrials.gov processed this record on September 30, 2016