NCT01069692

Brief Summary

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

Trial Health

85
On Track

Trial Health Score

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

Enrollment
115

participants targeted

Target at P25-P50 for phase_3

Geographic Reach
2 countries

9 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

Study Start

First participant enrolled

February 1, 2010

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

February 15, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 17, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Last Updated

December 19, 2020

Status Verified

July 1, 2011

Enrollment Period

8 months

First QC Date

February 15, 2010

Last Update Submit

December 11, 2020

Conditions

HyperphosphatemiaChronic Kidney Disease

Keywords

Chronic Kidney DiseaseHemodialysisHyperphosphatemiaHyperphosphatemia patients with chronic kidney disease on 3x/week hemodialysis

Outcome Measures

Primary Outcomes (1)

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

    6 weeks

Secondary Outcomes (3)

  • Evaluate changes in serum phosphate during a 2 week random treatment withdrawal period of SBR759 after 4 weeks treatment

    6 weeks

  • Evaluate dose-dependent efficacy of SBR759

    6 weeks

  • Compare the short-term safety profile and dose-dependent tolerability of SBR759 dosed with meals taken 3 times a day to that of placebo

    6 weeks

Study Arms (5)

Arm 1

PLACEBO COMPARATOR

Placebo

Drug: SBR759A

Arm 3

EXPERIMENTAL
Drug: SBR759A

Arm 2

EXPERIMENTAL
Drug: SBR759A

arm 4

EXPERIMENTAL

SBR759A

Drug: SBR759A

arm 5

EXPERIMENTAL
Drug: SBR759A

Interventions

SBR759ADRUG

SBR759A 6g daily

Arm 3

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 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

You may not qualify if:

  • 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%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Novartis Investigative Site

Jette, 1090, Belgium

Location

Novartis Investigative Site

Liège, 4000, Belgium

Location

Novartis Investigative Site

Roeselare, 8800, Belgium

Location

Novartis Investigative Site

Brescia, 25123, Italy

Location

Novartis Investigative Site

Lecco, 23900, Italy

Location

Novartis Investigator Site

Lucca, 55100, Italy

Location

Novartis Investigative Site

Napoli, 80131, Italy

Location

Novartis Investigative Site

Pavia, 27100, Italy

Location

Novartis Investigative Site

Siena, 53100, Italy

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

  • 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.

    PMID: 23670305DERIVED

Related Links

MeSH Terms

Conditions

HyperphosphatemiaRenal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

  • Novartis Pharmceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 15, 2010

First Posted

February 17, 2010

Study Start

February 1, 2010

Primary Completion

October 1, 2010

Last Updated

December 19, 2020

Record last verified: 2011-07

Locations

BE(3)IT(6)