RecruitingPhase 2NCT05766839

Patiromer for Treatment of Hyperkalaemia in Children Under 12 Years of Age

A 2-Part, Open-Label, Phase 2, Multiple Dose Study to Evaluate the Pharmacodynamic Effects, Safety, and Tolerability of Patiromer in Children Under 12 Years of Age With Hyperkalaemia (EMERALD2)

Sponsor

Vifor Pharma, Inc.

Enrollment

32 participants

Start Date

Apr 6, 2025

Study Type

INTERVENTIONAL

Conditions

Hyperkalemia

Summary

A study to evaluate the pharmacodynamic effects, safety, and tolerability of patiromer in children under 12 years of age with hyperkalaemia.

Eligibility

Min Age: 0 YearsMax Age: 11 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Patiromer for people with hyperkalemia. The study is currently recruiting participants at 37 locations. People eligible for this study include aged 0 Years to 11 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPatiromer

Patiromer will be given once daily; In Cohort 3, depending on the dose and the study participant's age, the total daily dose might be split

Locations(37)

Children's Hospital Colorado

Aurora, Colorado, United States

UF Health Pediatric Multispecialty Center Site

Jacksonville, Florida, United States

Miller School of Medicine, University of Miami

Miami, Florida, United States

Arnold Palmer Hospital for Children

Orlando, Florida, United States

Augusta University - Children's Hospital of Georgia

Augusta, Georgia, United States

University of Illinois College of Medicine

Peoria, Illinois, United States

Boston Children's Hospital

Boston, Massachusetts, United States

Children's Mercy Hospitals and Clinics

Kansas City, Missouri, United States

Northwell Health Cohen Children's Medical Center

New York, New York, United States

Duke University Hospital

Durham, North Carolina, United States

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Vanderbilt Children's Hospital Neurology

Nashville, Tennessee, United States

Texas Tech University Health Sciences Center Amarillo

Amarillo, Texas, United States

Monash Medical Centre Clayton

Clayton, Australia

The Royal Children's Hospital (RCH)

Parkville, Australia

Children's Hospital Westmead Centre for Kidney Research

Westmead, Australia

Universitair Ziekenhuis Gent

Ghent, Belgium

UZ Leuven

Leuven, Belgium

Helsingin Yliopistollinen Keskussairaala Uusi Lastensairaala

Helsinki, Finland

CHRU Montpellier - Arnaud de Villeneuve

Montpellier, France

Assistance Publique-Hopitaux de Paris Robert-Debre

Paris, France

Hôpital des Enfants - Toulouse

Toulouse, France

Ippokratio Thessaloniki General Hospital

Thessaloniki, Thessaloniki, Greece

Pan and Aglaia Kyriakou Children's Hospital

Athens, Greece

Shaare Zedek Medical Center

Jerusalem, Israel

Schneider Children's Medical Center of Israel

Petach Tikvah, Israel

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Italy

IRCCS Ospedale Pediatrico Bambino Gesù

Rome, Italy

Helse Bergen HF Haukeland Universitetssjukehus

Bergen, Norway

Uniwersytecki Szpital Kliniczny we Wrocławiu

Wroclaw, Poland

Unidade Local de Saude de Santo Antonio, E.P.E.

Porto, Portugal

Sidra Medicine

Doha, Qatar

Spitalul Clinic de Urgenta pentru Copii Louis Turcanu Timisoara

Timișoara, Romania

King Saud University

Riyadh, Saudi Arabia

King Faisal Specialist Hospital & Research Centre

Riyadh, Saudi Arabia

King Abdulaziz Medical City

Riyadh, Saudi Arabia

Al Jalila Children's Hospital

Dubai, United Arab Emirates

View Full Details on ClinicalTrials.gov

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NCT05766839

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Patiromer for Treatment of Hyperkalaemia in Children Under 12 Years of Age

Conditions

Summary

Eligibility

Plain Language Summary

Interventions

Locations(37)

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