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A Clinical Study to Evaluate the Safety, Tolerability and Activity of a New Phosphate Binder (SBR759) in Patients With Chronic Kidney Disease on Hemodialysis

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00750295
First received: September 9, 2008
Last updated: August 17, 2011
Last verified: August 2011
History of Changes

September 9, 2008
August 17, 2011
February 2007
January 2008   (final data collection date for primary outcome measure)
In addition to the standard safety assessments (vital signs, ECGs, clinical chemistry and adverse events), serum phosphorus concentration is frequently measured during the study.
Same as current
Complete list of historical versions of study NCT00750295 on ClinicalTrials.gov Archive Site
Several biomarkers and patient-reported outcomes are assessed at specified time points, before and after treating patients with the study drug.
Same as current
Not Provided
Not Provided
 
A Clinical Study to Evaluate the Safety, Tolerability and Activity of a New Phosphate Binder (SBR759) in Patients With Chronic Kidney Disease on Hemodialysis
An Open Label, Multiple Dose, Time-lagged, Switch Study to Evaluate the Safety, Tolerability and Activity of Escalating SBR759 Doses in Patients With Chronic Kidney Disease on Hemodialysis

The primary objective of this study is to assess the safety, tolerability and activity of escalating multiple doses of SBR759 in patients with chronic kidney disease on hemodialysis.
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Kidney Disease
Drug: SBR759
Four weeks of treatment with different doses of SBR759. Patients maintain their prescribed dose of other phosphate binders during the run-in period.
  • Experimental: 1
    Intervention: Drug: SBR759
  • Experimental: 2
    Intervention: Drug: SBR759
  • Experimental: 3
    Intervention: Drug: SBR759
  • Experimental: 4
    Intervention: Drug: SBR759
  • Experimental: 5
    Intervention: Drug: SBR759
  • Experimental: 6
    Intervention: Drug: SBR759
  • Experimental: 7
    Intervention: Drug: SBR759
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
January 2008
January 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients must be treated with maintenance hemodialysis and prescribed a phosphate binder.
  • A controlled serum phosphorus.
  • Constant dose of concomitant medications.
  • Women of child bearing potential must be practicing an acceptable form of birth control (i.e. double barrier method - intrauterine device plus condom, spermicidal gel plus condom). All female patients must have a negative pregnancy test at screening in order to be eligible to participate in the study.

Exclusion Criteria:

  • Patient has been hospitalized within 30 days prior to screening or has a surgery scheduled during the study.
  • Patient has an unstable medical condition, an active infection, active malignancy (except for basal cell carcinoma of the skin), a history of major GI tract surgery, or a history of hemochromatosis.
  • Patient is receiving or has received an investigational drug (or is currently using an investigational device) within 30 days prior to screening.

Other protocol-defined inclusion/exclusion criteria may apply.
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00750295
CSBR759A2101
No
External Affairs, Novartis Pharmaceuticals
Novartis Pharmaceuticals
Not Provided
Principal Investigator: Novartis Novartis Investigator Site
Novartis
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP