NCT00704678

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

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
203

participants targeted

Target at P75+ for phase_2

Geographic Reach
2 countries

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 25, 2008

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Last Updated

September 23, 2016

Status Verified

September 1, 2016

Enrollment Period

1.8 years

First QC Date

June 23, 2008

Last Update Submit

September 22, 2016

Conditions

Chronic Kidney Disease

Keywords

Chronic Kidney DiseasehemodialysishyperphosphatemiaAsianpatients

Outcome Measures

Primary Outcomes (1)

  • Responder rates achieving target serum phosphate levels.

    Week 12

Secondary Outcomes (1)

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

    Week 12

Study Arms (4)

1

EXPERIMENTAL

1g bid

Drug: SBR759

2

ACTIVE COMPARATOR

0.8 g tid

Drug: Sevelamer HCl

3

EXPERIMENTAL

1.5 g tid

Drug: Sevelamer HCl

4

ACTIVE COMPARATOR

1.6 g tid

Drug: Sevelamer HCl

Interventions

SBR759DRUG

1g tid

1
Sevelamer HClDRUG

1.6 g tid

4

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Novartis Investigative Site

Kōriyama, Fukushima, Japan

Location

Novartis Investigative Site

Midori, Gunma, Japan

Location

Novartis Investigative Site

Hitachiomiya, Ibaraki, Japan

Location

Novartis Investigative Site

Moriya, Ibaraki, Japan

Location

Novartis Investigative Site

Sashima-gun, Ibaraki, Japan

Location

Novartis Investigative Site

Takamatsu, Kagawa-ken, Japan

Location

Novartis Investigative Site

Tsu, Mie-ken, Japan

Location

Novartis Investigative Site

Nagano, Nagano, Japan

Location

Novartis Investigative Site

Okayama, Okayama-ken, Japan

Location

Novartis Investigative Site

Sakai, Osaka, Japan

Location

Novartis Investigative Site

Kasukabe, Saitama, Japan

Location

Novartis Investigative Site

Shizuoka, Shizuoka, Japan

Location

Novartis Investigative Site

Changhua, Taiwan

Location

Novartis Investigative Site

Kaoshiung, Taiwan

Location

Novartis Investigative Site

Taipei, Taiwan

Location

Related Publications (2)

  • Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.

    PMID: 40576086DERIVED

  • 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.

    PMID: 21854503DERIVED

MeSH Terms

Conditions

Renal Insufficiency, ChronicHyperphosphatemia

Interventions

SBR 759Sevelamer

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsPhosphorus Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

PolyaminesAminesOrganic Chemicals

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2008

First Posted

June 25, 2008

Study Start

August 1, 2008

Primary Completion

June 1, 2010

Last Updated

September 23, 2016

Record last verified: 2016-09

Locations

TW(3)JP(12)