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Placebo Versus SBR759 in Lowering Phosphate in Dialysis Patients | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Placebo Versus SBR759 in Lowering Phosphate in Dialysis Patients

A Double-blind, Randomized, Placebo-controlled Multi-center Trial to Compare the Phosphate Lowering Efficacy of Different Doses of SBR759 to Placebo

NCT01069692•Novartis

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - No limit years

Sex

ALL

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%

Locations (9)

Novartis Investigative Site

Jette, Belgium

Novartis Investigative Site

Liège, Belgium

Novartis Investigative Site

Roeselare, Belgium

Novartis Investigative Site

Brescia, Italy

Novartis Investigative Site

Lecco, Italy

Novartis Investigator Site

Lucca, Italy

Novartis Investigative Site

Naples, Italy

Novartis Investigative Site

Pavia, Italy

Novartis Investigative Site

Siena, Italy

Key Dates

Start Date

February 1, 2010

Primary Completion Date

October 1, 2010

Last Updated

December 19, 2020

Enrollment

115

ACTUAL participants

Conditions

HyperphosphatemiaChronic Kidney Disease

Interventions

SBR759A

DRUG

SBR759A

DRUG

SBR759A

DRUG

SBR759A

DRUG

SBR759A

DRUG

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NCT07241390

Atherosclerosis Cardiovascular DiseaseChronic Kidney Disease

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RECRUITINGPHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 19, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Placebo Versus SBR759 in Lowering Phosphate in Dialysis Patients

Inclusion Criteria

Exclusion Criteria

A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease (ATTAIN-Outcomes)

A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Chronic Kidney Disease

A Research Study Comparing How Well Different Doses of the Medicine NNC0519-0130 Can Reduce Kidney Damage in People Living With Chronic Kidney Disease

OPTIMISE-CKD Study_Dapagliflozin Effectiveness in CKD

Prevalence of Gastric Motor Dysfunction and Upper GI Symptoms in Gastric Antral Vascular Ectasias

Human Amniotic-Derived Mesenchymal Stem Cell Therapy for Calciphylaxis