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

December 11, 2020 updated by: Novartis Pharmaceuticals

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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Four weeks of treatment with different doses of SBR759. Patients maintain their prescribed dose of other phosphate binders during the run-in period.
Experimental: 2
Four weeks of treatment with different doses of SBR759. Patients maintain their prescribed dose of other phosphate binders during the run-in period.
Experimental: 3
Four weeks of treatment with different doses of SBR759. Patients maintain their prescribed dose of other phosphate binders during the run-in period.
Experimental: 4
Four weeks of treatment with different doses of SBR759. Patients maintain their prescribed dose of other phosphate binders during the run-in period.
Experimental: 5
Four weeks of treatment with different doses of SBR759. Patients maintain their prescribed dose of other phosphate binders during the run-in period.
Experimental: 6
Four weeks of treatment with different doses of SBR759. Patients maintain their prescribed dose of other phosphate binders during the run-in period.
Experimental: 7
Four weeks of treatment with different doses of SBR759. Patients maintain their prescribed dose of other phosphate binders during the run-in period.

What is the study measuring?

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

September 9, 2008

First Submitted That Met QC Criteria

September 9, 2008

First Posted (Estimate)

September 10, 2008

Study Record Updates

Last Update Posted (Actual)

December 19, 2020

Last Update Submitted That Met QC Criteria

December 11, 2020

Last Verified

August 1, 2011

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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