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Optimal Titration Regimen for SBR759 in Lowering Serum Phosphate Levels in Asian Chronic Kidney Disease Patients on Hemodialysis (SBR759)

Primary Purpose

Chronic Kidney Disease

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

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Chronic Kidney Disease, hemodialysis, hyperphosphatemia, Asian, patients

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 or 20 years old in Japan.
  • Stable maintenance of hemodialysis 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 or a non-conventional hemodialysis technique .
  • Parathyroidectomy or transplant scheduled during the study.
  • Uncontrolled hyperparathyroidism
  • History of hemochromatosis or ferritin > 800 µg/L.
  • Clinically significant GI disorder
  • Unstable medical condition other than Chronic Kidney Disease.
  • Treated with sevelamer HCl monotherapy or SBR759.
  • Treated with oral iron.
  • Other protocol-defined inclusion/exclusion criteria may apply.

Sites / Locations

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

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 bid

0.8 g tid

1.5 g tid

1.6 g tid

Outcomes

Primary Outcome Measures

Responder rates achieving target serum phosphate levels.

Secondary Outcome Measures

Responder rates in target patients with serum calcium-phosphate levels.

Full Information

First Posted
June 23, 2008
Last Updated
September 22, 2016
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00704678
Brief Title
Optimal Titration Regimen for SBR759 in Lowering Serum Phosphate Levels in Asian Chronic Kidney Disease Patients on Hemodialysis
Acronym
SBR759
Official Title
A 12-week, Open Label, Multicenter, Titration Study, With a 12 Month Extension, to Determine the Optimal Titration Regimen for SBR759, Compared to Sevelamer HCl, in Lowering Serum Phosphate Levels in Asian Patients With Chronic Kidney Disease on Hemodialysis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
June 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 determine the titration regimen for SBR759 compared to sevelamer HCl in lowering serum phosphate levels in Asian 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
Chronic Kidney Disease
Keywords
Chronic Kidney Disease, hemodialysis, hyperphosphatemia, Asian, patients

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
1g bid
Arm Title
2
Arm Type
Active Comparator
Arm Description
0.8 g tid
Arm Title
3
Arm Type
Experimental
Arm Description
1.5 g tid
Arm Title
4
Arm Type
Active Comparator
Arm Description
1.6 g tid
Intervention Type
Drug
Intervention Name(s)
SBR759
Intervention Description
1g tid
Intervention Type
Drug
Intervention Name(s)
Sevelamer HCl
Intervention Description
1.6 g tid
Intervention Type
Drug
Intervention Name(s)
Sevelamer HCl
Intervention Description
1.5 g tid
Intervention Type
Drug
Intervention Name(s)
Sevelamer HCl
Intervention Description
0.8 g tid
Primary Outcome Measure Information:
Title
Responder rates achieving target serum phosphate levels.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Responder rates in target patients with serum calcium-phosphate levels.
Time Frame
Week 12

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 or 20 years old in Japan. Stable maintenance of hemodialysis 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 or a non-conventional hemodialysis technique . Parathyroidectomy or transplant scheduled during the study. Uncontrolled hyperparathyroidism History of hemochromatosis or ferritin > 800 µg/L. Clinically significant GI disorder Unstable medical condition other than Chronic Kidney Disease. Treated with sevelamer HCl monotherapy or SBR759. Treated with oral iron. Other protocol-defined inclusion/exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Koriyama
State/Province
Fukushima
Country
Japan
Facility Name
Novartis Investigative Site
City
Midori
State/Province
Gunma
Country
Japan
Facility Name
Novartis Investigative Site
City
Hitachiomiya
State/Province
Ibaraki
Country
Japan
Facility Name
Novartis Investigative Site
City
Moriya
State/Province
Ibaraki
Country
Japan
Facility Name
Novartis Investigative Site
City
Sashima-gun
State/Province
Ibaraki
Country
Japan
Facility Name
Novartis Investigative Site
City
Takamatsu
State/Province
Kagawa
Country
Japan
Facility Name
Novartis Investigative Site
City
Tsu
State/Province
Mie
Country
Japan
Facility Name
Novartis Investigative Site
City
Okayama City
State/Province
Okayama
Country
Japan
Facility Name
Novartis Investigative Site
City
Sakai
State/Province
Osaka
Country
Japan
Facility Name
Novartis Investigative Site
City
Kasukabe
State/Province
Saitama
Country
Japan
Facility Name
Novartis Investigative Site
City
Nagano
Country
Japan
Facility Name
Novartis Investigative Site
City
Shizuoka
Country
Japan
Facility Name
Novartis Investigative Site
City
Changhua
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Kaoshiung
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Taipei
Country
Taiwan

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
derived

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Optimal Titration Regimen for SBR759 in Lowering Serum Phosphate Levels in Asian Chronic Kidney Disease Patients on Hemodialysis

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