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

Purpose

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.

Condition	Intervention	Phase
Chronic Kidney Disease	Drug: SBR759	Phase I Phase II

MedlinePlus related topics:

Dialysis Kidney Failure

ChemIDplus related topics:

Phosphorus Benzocaine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study

Official Title:	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

Further study details as provided by Novartis:

Primary Outcome Measures:

In addition to the standard safety assessments (vital signs, ECGs, clinical chemistry and adverse events), serum phosphorus concentration is frequently measured during the study.

Secondary Outcome Measures:

Several biomarkers and patient-reported outcomes are assessed at specified time points, before and after treating patients with the study drug.

Enrollment:	60
Study Start Date:	February 2007
Study Completion Date:	January 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	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.
2: Experimental	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.
3: Experimental	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.
4: Experimental	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.
5: Experimental	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.
6: Experimental	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.
7: Experimental	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.

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00750295

Locations


United States, Colorado
	Novartis Investigator Site
	Denver, Colorado, United States, 80230

Sponsors and Collaborators

Novartis

Investigators


Principal Investigator:	Novartis	Novartis Investigator Site

More Information

Responsible Party:	( External Affairs )
Study ID Numbers:	CSBR759A2101
First Received:	September 9, 2008
Last Updated:	September 9, 2008
ClinicalTrials.gov Identifier:	NCT00750295
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Chronic kidney disease,

hemodialysis,

serum phosphorus,

phosphate binders

Study placed in the following topic categories:

Renal Insufficiency

Urologic Diseases

Renal Insufficiency, Chronic

Benzocaine

Kidney Failure, Chronic

Kidney Diseases

Kidney Failure

ClinicalTrials.gov processed this record on October 06, 2008

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00750295