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Placebo Versus SBR759 in Lowering Phosphate in Dialysis Patients (SBR759)

Primary Purpose

Hyperphosphatemia, Chronic Kidney Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
SBR759A
SBR759A
SBR759A
SBR759A
SBR759A
Sponsored by
Novartis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperphosphatemia focused on measuring Chronic Kidney Disease, Hemodialysis, Hyperphosphatemia, Hyperphosphatemia patients with chronic kidney disease on 3x/week hemodialysis

Eligibility Criteria

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

Inclusion criteria:

  1. Men or women of at least 18 years of age
  2. Stable maintenance of hemodialysis 3 times per week for 3 months or greater
  3. Controlled serum phosphate if under phosphate-binder therapy
  4. Patient must either be on a stable phosphate binder dose and are willing to stop their phosphate binder therapy at the beginning of the study, or not have received any phosphate binder therapy for at least 4 weeks prior to screening

Exclusion criteria:

  1. Patients who are on peritoneal dialysis
  2. Patients who have a transplant or parathyroidectomy scheduled during the study
  3. Clinically significant GI disorder
  4. Unstable medical condition other than Chronic Kidney Disease
  5. Patient is currently being treated with oral iron
  6. History of hemachromatosis, or ferritin > 1000 ng/mL
  7. Transferrin saturation > 60%
  8. Uncontrolled hyperparathyroidism (iPTH > 84.8 pmol/L) 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 Investigator Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Arm Label

Arm 1

Arm 3

Arm 2

arm 4

arm 5

Arm Description

Placebo

SBR759A

Outcomes

Primary Outcome Measures

Evaluate the change from baseline in 72-hour serum phosphate levels of 4 different doses of SBR759 versus placebo over 4 weeks of treatment

Secondary Outcome Measures

Evaluate changes in serum phosphate during a 2 week random treatment withdrawal period of SBR759 after 4 weeks treatment
Evaluate dose-dependent efficacy of SBR759
Compare the short-term safety profile and dose-dependent tolerability of SBR759 dosed with meals taken 3 times a day to that of placebo

Full Information

First Posted
February 15, 2010
Last Updated
December 11, 2020
Sponsor
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT01069692
Brief Title
Placebo Versus SBR759 in Lowering Phosphate in Dialysis Patients
Acronym
SBR759
Official Title
A Double-blind, Randomized, Placebo-controlled Multi-center Trial to Compare the Phosphate Lowering Efficacy of Different Doses of SBR759 to Placebo
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis

4. Oversight

5. Study Description

Brief Summary
This study will compare placebo to 4 different doses of SBR759 to assess the phosphate lowering efficacy in dialysis patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperphosphatemia, Chronic Kidney Disease
Keywords
Chronic Kidney Disease, Hemodialysis, Hyperphosphatemia, Hyperphosphatemia patients with chronic kidney disease on 3x/week hemodialysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
115 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
Arm 3
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Experimental
Arm Title
arm 4
Arm Type
Experimental
Arm Description
SBR759A
Arm Title
arm 5
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
SBR759A
Intervention Description
SBR759A 6g daily
Intervention Type
Drug
Intervention Name(s)
SBR759A
Intervention Description
Placebo Comparator 0g daily
Intervention Type
Drug
Intervention Name(s)
SBR759A
Intervention Description
SBR759A 3g daily
Intervention Type
Drug
Intervention Name(s)
SBR759A
Intervention Description
9g daily
Intervention Type
Drug
Intervention Name(s)
SBR759A
Intervention Description
12g daily
Primary Outcome Measure Information:
Title
Evaluate the change from baseline in 72-hour serum phosphate levels of 4 different doses of SBR759 versus placebo over 4 weeks of treatment
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Evaluate changes in serum phosphate during a 2 week random treatment withdrawal period of SBR759 after 4 weeks treatment
Time Frame
6 weeks
Title
Evaluate dose-dependent efficacy of SBR759
Time Frame
6 weeks
Title
Compare the short-term safety profile and dose-dependent tolerability of SBR759 dosed with meals taken 3 times a day to that of placebo
Time Frame
6 weeks

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 of age Stable maintenance of hemodialysis 3 times per week for 3 months or greater Controlled serum phosphate if under phosphate-binder therapy Patient must either be on a stable phosphate binder dose and are willing to stop their phosphate binder therapy at the beginning of the study, or not have received any phosphate binder therapy for at least 4 weeks prior to screening Exclusion criteria: Patients who are on peritoneal dialysis Patients who have a transplant or parathyroidectomy scheduled during the study Clinically significant GI disorder Unstable medical condition other than Chronic Kidney Disease Patient is currently being treated with oral iron History of hemachromatosis, or ferritin > 1000 ng/mL Transferrin saturation > 60% Uncontrolled hyperparathyroidism (iPTH > 84.8 pmol/L) Other protocol-defined inclusion/exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Jette
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Novartis Investigative Site
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Novartis Investigative Site
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
Novartis Investigative Site
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Novartis Investigative Site
City
Lecco
ZIP/Postal Code
23900
Country
Italy
Facility Name
Novartis Investigator Site
City
Lucca
ZIP/Postal Code
55100
Country
Italy
Facility Name
Novartis Investigative Site
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Novartis Investigative Site
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Novartis Investigative Site
City
Siena
ZIP/Postal Code
53100
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
23670305
Citation
Fukagawa M, Kasuga H, Joseph D, Sawata H, Junge G, Moore A, Akiba T. Efficacy and safety of SBR759, a novel calcium-free, iron (III)-based phosphate binder, versus placebo in chronic kidney disease stage V Japanese patients on maintenance renal replacement therapy. Clin Exp Nephrol. 2014 Feb;18(1):135-43. doi: 10.1007/s10157-013-0815-7. Epub 2013 May 15.
Results Reference
derived
Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=4647
Description
Results for CSBR759A2304 from the Novartis Clinical Trials website

Learn more about this trial

Placebo Versus SBR759 in Lowering Phosphate in Dialysis Patients

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