Efficacy of SBR759 in Lowering Serum Phosphate Levels in Chronic Kidney Disease Patients on Hemodialysis (SBR759)

December 11, 2020 updated by: Novartis Pharmaceuticals

A 12-week, Open Label, Multicenter, Titration Study, With a 9-month Maintenance Treatment Extension, to Demonstrate Efficacy of SBR759 Compared to Sevelamer HCl in Lowering Serum Phosphate Levels in Chronic Kidney Disease Patients on Hemodialysis

This study will evaluate the efficacy of SBR759 compared to sevelamer HCl in lowering serum phosphate levels in Chronic Kidney Disease patients on hemodialysis

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

321

Phase

  • Phase 2

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

  • Australia
      • Melbourne, Australia, 3065
        • Novartis
      • South Brisbane, Australia
        • Novartis
      • Woolloongabba, Australia, 4102
        • Novartis
    • South Australia
      • Adelaide, South Australia, Australia
        • Novartis
    • Victoria
      • Fitzroy, Victoria, Australia
        • Novartis
      • Parkville, Victoria, Australia, 3052
        • Novartis
  • Belgium
      • Antwerpen, Belgium
        • Novartis Investigative Site
      • Brugge, Belgium, 8000
        • Novartis
      • Bruxelles, Belgium, 1000
        • Novartis
      • Liege, Belgium, 4000
        • Novartis
      • Saint Niklaas, Belgium
        • Novartis Investigative Site
  • Canada
      • Edmonton, Canada
        • Novartis Investigative Site
      • London, Canada
        • Novartis Investigative Site
      • Oshawa, Canada
        • Novartis Investigative Site
      • Quebec, Canada
        • Novartis Investigative Site
  • Finland
      • Helsinki, Finland, 00100
        • Novartis
      • Oulu, Finland, 90100
        • Novartis
      • Tampere, Finland, 33100
        • Novartis
      • Turku, Finland, 20100
        • Novartis
  • France
      • Amiens, France, 80054
        • Novartis
      • Fleury Merogis, France
        • Novartis
      • Lyon Cedex, France, 69446
        • Novartis
      • Rheims Cedex, France, 51685
        • Novartis
      • Salouel, France, 80480
        • Novartis
  • Germany
      • Berlin, Germany
        • Novartis Investigative Site
      • Coburg, Germany
        • Novartis Investigative Site
  • Italy
      • Lecco, Italy
        • Novartis Investigative Site
      • Lodi, Italy
        • Novartis Investigative Site
      • Milano, Italy
        • Novartis Investigative Site
      • Modena, Italy
        • Novartis Investigative Site
      • Pavia, Italy
        • Novartis Investigative Site
  • Norway
      • Bergen, Norway, 5011
        • Novartis
      • Kristiansand, Norway, 1001
        • Novartis
      • Oslo, Norway, 0027
        • Novartis
      • Tonsberg, Norway
        • Novartis
  • Puerto Rico
      • San Juan, Puerto Rico, 00927
        • Novartis
  • Sweden
      • Jonkoping, Sweden
        • Novartis Investigative Site
      • Karlstad, Sweden
        • Novartis Investigative Site
      • Skovde, Sweden
        • Novartis Investigative Site
      • Stockholm, Sweden
        • Novartis Investigative Site
  • Switzerland
      • Aarau, Switzerland, 5000
        • Novartis
      • Lausanne, Switzerland, 1011
        • Novartis
      • Zurich, Switzerland, 8091
        • Novartis
  • United Kingdom
      • Hull, United Kingdom
        • Novartis
      • Manchester, United Kingdom
        • Novartis Investigative Site
      • Portsmouth, United Kingdom
        • Novartis Investigative Site
      • Salford, United Kingdom
        • Novartis
  • United States
    • California
      • Chula Vista, California, United States, 91910
        • Novartis
      • La Mesa, California, United States, 91942
        • Novartis
      • Whittier, California, United States, 90602
        • Novartis
    • Colorado
      • Denver, Colorado, United States, 80262
        • Novartis
    • Illinois
      • North Chicago, Illinois, United States, 60064
        • Novartis
      • Peoria, Illinois, United States, 61602
        • Novartis
    • Indiana
      • Mishawaka, Indiana, United States, 46545
        • Novartis
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Novartis
    • Massachusetts
      • Fall River, Massachusetts, United States, 02720
        • Novartis
      • Springfield, Massachusetts, United States, 01104
        • Novartis
    • Nebraska
      • Omaha, Nebraska, United States, 68144
        • Novartis Investigative Site
    • New York
      • New York, New York, United States, 10032
        • Novartis
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157-1082
        • Novartis
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • Novarits
    • Oregon
      • Portland, Oregon, United States, 97210
        • Novartis
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15224
        • Novartis
    • Texas
      • Houston, Texas, United States, 77024
        • Novartis Investigative Site
      • San Antonio, Texas, United States, 78207
        • Novartis
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Novartis

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria

  • Men or women of at least 18 years old.
  • Stable maintenance of renal replacement therapy 3 times per week.
  • Controlled Serum phosphate if under phosphate-binder therapy.
  • Serum phosphate level ≥ 6.0 mg/dL (> 1.9 mmol/L) prior to study treatment initiation.

Exclusion criteria

  • Peritoneal dialysis.
  • Parathyroidectomy or transplant scheduled during the study.
  • Uncontrolled hyperparathyroidism
  • History of hemochromatosis or ferritin > 1000 µg/L.
  • Clinically significant GI disorder
  • Unstable medical condition other than Chronic Kidney Disease.
  • Treated with oral iron.
  • 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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
1g tid
Drug: SBR759
Starting dose of 1g or 1.5g tid, with an increase of 1g tid every 2 weeks until serum phosphate level fall below target.
Drug: SBR759
1.5 g tid
Active Comparator: 2
Sevelamer HCl
Drug: Sevelamer HCl
0.8 g tid
Drug: Sevelamer HCl
1.6 g tid
Experimental: 3
SBR759 1.5 g tid
Drug: SBR759
Starting dose of 1g or 1.5g tid, with an increase of 1g tid every 2 weeks until serum phosphate level fall below target.
Drug: SBR759
1.5 g tid
Active Comparator: 4
Sevelamer HCl
Drug: Sevelamer HCl
0.8 g tid
Drug: Sevelamer HCl
1.6 g tid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Responder rates in target serum phosphate levels at 12 weeks Evaluate efficacy of SBR759 compared to sevelamer HCl at 12 weeks
Time Frame: Time Frame: 12 weeks + 12 months
Time Frame: 12 weeks + 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Responder rates in target patients with serum calcium-phosphate levels at 12 weeks/12 months
Time Frame: Time Frame: 12 weeks / 12 months
Time Frame: 12 weeks / 12 months

Collaborators and Investigators

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

Sponsor

Novartis Pharmaceuticals

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.

General Publications

Helpful Links

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

July 1, 2008

Primary Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

June 23, 2008

First Submitted That Met QC Criteria

June 24, 2008

First Posted (Estimate)

June 25, 2008

Study Record Updates

Last Update Posted (Actual)

December 19, 2020

Last Update Submitted That Met QC Criteria

December 11, 2020

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSBR759A2201
  • EUDRACT No.: 2006-001787-23

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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