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

Primary Purpose

Hyperphosphatemia Patients With Chronic Kidney Disease on 3x/Week Replacement Therapy

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
SBR759
Sevelamer HCl
SBR759
Sevelamer HCl
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperphosphatemia Patients With Chronic Kidney Disease on 3x/Week Replacement Therapy focused on measuring Chronic Kidney Disease, hemodialysis, hyperphosphatemia, hemodiafiltration

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Novartis
  • Novartis
  • Novartis
  • Novartis
  • Novartis
  • Novartis
  • Novartis
  • Novartis
  • Novartis
  • Novartis
  • Novartis Investigative Site
  • Novartis
  • Novartis
  • Novarits
  • Novartis
  • Novartis
  • Novartis Investigative Site
  • Novartis
  • Novartis
  • Novartis
  • Novartis
  • Novartis
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  • Novartis
  • Novartis
  • Novartis Investigative Site
  • Novartis
  • Novartis
  • Novartis
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis
  • Novartis
  • Novartis
  • Novartis
  • Novartis
  • Novartis
  • Novartis
  • Novartis
  • Novartis
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis
  • Novartis
  • Novartis
  • Novartis
  • Novartis
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis
  • Novartis
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  • Novartis
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

1

2

3

4

Arm Description

1g tid

Sevelamer HCl

SBR759 1.5 g tid

Sevelamer HCl

Outcomes

Primary Outcome Measures

Responder rates in target serum phosphate levels at 12 weeks Evaluate efficacy of SBR759 compared to sevelamer HCl at 12 weeks

Secondary Outcome Measures

Responder rates in target patients with serum calcium-phosphate levels at 12 weeks/12 months

Full Information

First Posted
June 23, 2008
Last Updated
December 11, 2020
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00704483
Brief Title
Efficacy of SBR759 in Lowering Serum Phosphate Levels in Chronic Kidney Disease Patients on Hemodialysis
Acronym
SBR759
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperphosphatemia Patients With Chronic Kidney Disease on 3x/Week Replacement Therapy
Keywords
Chronic Kidney Disease, hemodialysis, hyperphosphatemia, hemodiafiltration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
321 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
1g tid
Arm Title
2
Arm Type
Active Comparator
Arm Description
Sevelamer HCl
Arm Title
3
Arm Type
Experimental
Arm Description
SBR759 1.5 g tid
Arm Title
4
Arm Type
Active Comparator
Arm Description
Sevelamer HCl
Intervention Type
Drug
Intervention Name(s)
SBR759
Intervention Description
Starting dose of 1g or 1.5g tid, with an increase of 1g tid every 2 weeks until serum phosphate level fall below target.
Intervention Type
Drug
Intervention Name(s)
Sevelamer HCl
Intervention Description
0.8 g tid
Intervention Type
Drug
Intervention Name(s)
SBR759
Intervention Description
1.5 g tid
Intervention Type
Drug
Intervention Name(s)
Sevelamer HCl
Intervention Description
1.6 g tid
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Responder rates in target patients with serum calcium-phosphate levels at 12 weeks/12 months
Time Frame
Time Frame: 12 weeks / 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis
Organizational Affiliation
Novartis
Official's Role
Study Director
Facility Information:
Facility Name
Novartis
City
Chula Vista
State/Province
California
ZIP/Postal Code
91910
Country
United States
Facility Name
Novartis
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Novartis
City
Whittier
State/Province
California
ZIP/Postal Code
90602
Country
United States
Facility Name
Novartis
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Novartis
City
North Chicago
State/Province
Illinois
ZIP/Postal Code
60064
Country
United States
Facility Name
Novartis
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61602
Country
United States
Facility Name
Novartis
City
Mishawaka
State/Province
Indiana
ZIP/Postal Code
46545
Country
United States
Facility Name
Novartis
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Novartis
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02720
Country
United States
Facility Name
Novartis
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01104
Country
United States
Facility Name
Novartis Investigative Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
Novartis
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Novartis
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1082
Country
United States
Facility Name
Novarits
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Facility Name
Novartis
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Novartis
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Novartis Investigative Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Novartis
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78207
Country
United States
Facility Name
Novartis
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Novartis
City
Adelaide
State/Province
South Australia
Country
Australia
Facility Name
Novartis
City
Fitzroy
State/Province
Victoria
Country
Australia
Facility Name
Novartis
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Facility Name
Novartis
City
Melbourne
ZIP/Postal Code
3065
Country
Australia
Facility Name
Novartis
City
South Brisbane
Country
Australia
Facility Name
Novartis
City
Woolloongabba
ZIP/Postal Code
4102
Country
Australia
Facility Name
Novartis Investigative Site
City
Antwerpen
Country
Belgium
Facility Name
Novartis
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Novartis
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Novartis
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Novartis Investigative Site
City
Saint Niklaas
Country
Belgium
Facility Name
Novartis Investigative Site
City
Edmonton
Country
Canada
Facility Name
Novartis Investigative Site
City
London
Country
Canada
Facility Name
Novartis Investigative Site
City
Oshawa
Country
Canada
Facility Name
Novartis Investigative Site
City
Quebec
Country
Canada
Facility Name
Novartis
City
Helsinki
ZIP/Postal Code
00100
Country
Finland
Facility Name
Novartis
City
Oulu
ZIP/Postal Code
90100
Country
Finland
Facility Name
Novartis
City
Tampere
ZIP/Postal Code
33100
Country
Finland
Facility Name
Novartis
City
Turku
ZIP/Postal Code
20100
Country
Finland
Facility Name
Novartis
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
Novartis
City
Fleury Merogis
Country
France
Facility Name
Novartis
City
Lyon Cedex
ZIP/Postal Code
69446
Country
France
Facility Name
Novartis
City
Rheims Cedex
ZIP/Postal Code
51685
Country
France
Facility Name
Novartis
City
Salouel
ZIP/Postal Code
80480
Country
France
Facility Name
Novartis Investigative Site
City
Berlin
Country
Germany
Facility Name
Novartis Investigative Site
City
Coburg
Country
Germany
Facility Name
Novartis Investigative Site
City
Lecco
Country
Italy
Facility Name
Novartis Investigative Site
City
Lodi
Country
Italy
Facility Name
Novartis Investigative Site
City
Milano
Country
Italy
Facility Name
Novartis Investigative Site
City
Modena
Country
Italy
Facility Name
Novartis Investigative Site
City
Pavia
Country
Italy
Facility Name
Novartis
City
Bergen
ZIP/Postal Code
5011
Country
Norway
Facility Name
Novartis
City
Kristiansand
ZIP/Postal Code
1001
Country
Norway
Facility Name
Novartis
City
Oslo
ZIP/Postal Code
0027
Country
Norway
Facility Name
Novartis
City
Tonsberg
Country
Norway
Facility Name
Novartis
City
San Juan
ZIP/Postal Code
00927
Country
Puerto Rico
Facility Name
Novartis Investigative Site
City
Jonkoping
Country
Sweden
Facility Name
Novartis Investigative Site
City
Karlstad
Country
Sweden
Facility Name
Novartis Investigative Site
City
Skovde
Country
Sweden
Facility Name
Novartis Investigative Site
City
Stockholm
Country
Sweden
Facility Name
Novartis
City
Aarau
ZIP/Postal Code
5000
Country
Switzerland
Facility Name
Novartis
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
Novartis
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Novartis
City
Hull
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Manchester
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Portsmouth
Country
United Kingdom
Facility Name
Novartis
City
Salford
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
21854503
Citation
Chen JB, Chiang SS, Chen HC, Obayashi S, Nagasawa M, Hexham JM, Balfour A, Junge G, Akiba T, Fukagawa M. Efficacy and safety of SBR759, a novel calcium-free, iron(III)-based phosphate binder, in Asian patients undergoing hemodialysis: A 12-week, randomized, open-label, dose-titration study versus sevelamer hydrochloride. Nephrology (Carlton). 2011 Nov;16(8):743-50. doi: 10.1111/j.1440-1797.2011.01509.x.
Results Reference
result
Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=4645
Description
Results for CSBR759A2201 from the Novartis Clinical Trials Website

Learn more about this trial

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

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