Placebo Versus SBR759 in Lowering Phosphate in Dialysis Patients

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT01069692
First received: February 15, 2010
Last updated: July 20, 2011
Last verified: July 2011
  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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Men or women of at least 18 years of age
  2. Stable maintenance of hemodialysis 3 times per week for 3 months or greater
  3. Controlled serum phosphate if under phosphate-binder therapy
  4. 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:

  1. Patients who are on peritoneal dialysis
  2. Patients who have a transplant or parathyroidectomy scheduled during the study
  3. Clinically significant GI disorder
  4. Unstable medical condition other than Chronic Kidney Disease
  5. Patient is currently being treated with oral iron
  6. History of hemachromatosis, or ferritin > 1000 ng/mL
  7. Transferrin saturation > 60%
  8. 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

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

No publications provided

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
Hyperphosphatemia
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Phosphorus Metabolism Disorders
Metabolic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on July 28, 2014