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NCT05766839PHASE2Recruiting

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

Vifor Pharma, Inc.

Start Date

4/6/2025

Completion Date

12/1/2030

Summary

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

Eligibility Criteria

Age Range: No minimum to 11 years

Inclusion Criteria: * Paediatric participants (\<12 years of age) with hyperkalaemia at screening. * Participant's age should not reach 12 years during the 28 days of the pharmacodynamic/dose-ranging period. * Participant is able to receive regular external feeding and medication, including via tubes, i.e., percutaneous endoscopic gastrostomy (PEG) or entero-gastric feeding tube. * At screening/baseline, the results from 2 separate and consecutive potassium assessments using the same measurement method (whole blood, plasma, or serum) need to be above the age-appropriate upper limit of normal (ULN). * If taking any renin-angiotensin aldosterone system inhibitors (RAASi), beta blockers, fludrocortisone, or diuretic medications, must be on a stable dose for at least 14 days prior to screening. * Parent(s) or legally authorised representative(s) or another appropriate person delegated by the legally authorised representatives must be available to help the study-site personnel ensure follow-up; accompany the participant to the study site on each assessment day; accurately and reliably dispense investigational product as directed. * Females of childbearing potential must be non-lactating, must have a negative pregnancy test at screening, and must have used an effective, acceptable form of contraception (e.g., abstinence) for at least 1 month before patiromer administration. Females of childbearing potential must agree to continue using contraception throughout the study and for 1 month after the last dose of patiromer. * If undergoing peritoneal dialysis, participants must be on a stable treatment plan for a minimum of 4 weeks prior to screening, or at least 8 weeks prior to screening if newly initiated on peritoneal dialysis. Exclusion Criteria: * Preterm birth infants with \<37 weeks of gestation cannot be included in Cohort 3. * Participants who due to their general condition, e.g., anaemia or low body weight, are not suitable to have blood volume withdrawn. * Any of the following renal conditions: maintenance haemodialysis, renal artery stenosis, and acute kidney injury (defined by 2012 Kidney Disease Improving Global Outcomes) or a history of acute renal insufficiency in the past 3 months. Note: Chronic kidney disease (CKD) is not excluded. * A history of or current diagnosis of a severe gastrointestinal (GI) diagnosis or surgery that could affect GI transit of the drug (delayed gastric emptying), such as a severe swallowing disorder, severe gastroesophageal reflux, uncorrected pyloric stenosis, intussusception, any other intestinal obstruction (e.g., Hirschsprung disease, chronic intestinal pseudo-obstruction, clinically significant postsurgical abdominal adhesions) or any gut-shortening surgical procedure prior to screening. Pre-gastric above-mentioned pathologies may be disregarded in case of existence of a PEG or entero-gastric feeding tube, as the PEG or entero-gastric feeding tube will serve for nutrition and investigational product administration. * Active cancer, currently on cancer treatment, or history of cancer in the past 2 years (except for non-melanoma skin cancer). * Scheduled for kidney transplant procedure during the first 28 days after Day 1. * History of sudden infant death in a sibling (only for participants \<2 years of age at screening). * Use of the following medications if doses have not been stable for at least 14 days prior to screening or if doses are anticipated to change during the 4-week pharmacodynamic/ * Dose-ranging period: digoxin, bronchodilators, theophylline, heparins (including low molecular heparins), tacrolimus, mycophenolate mofetil, cyclosporine, trimethoprim, or cotrimoxazole. * Use of any investigational product for an unapproved indication within 30 days prior to screening or within 5 half-lives, whichever is longer. * Known hypersensitivity to patiromer or its components. * If the child is being breastfed: 1. There is suspicion of current alcohol or substance misuse/abuse in breastfeeding mother. 2. The breastfeeding mother is taking potassium supplements * Other protocol defined Inclusion/Exclusion criteria may apply.

Interventions

DRUG

Patiromer

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Conditions

Hyperkalemia

Locations

Children's Hospital Colorado

Aurora, Colorado 80045

United States

UF Health Pediatric Multispecialty Center Site

Jacksonville, Florida 32207

United States

Miller School of Medicine, University of Miami

Miami, Florida 33124

United States

Arnold Palmer Hospital for Children

Orlando, Florida 32806

United States

Augusta University - Children's Hospital of Georgia

Augusta, Georgia 30912

United States

University of Illinois College of Medicine

Peoria, Illinois 61605

United States

Boston Children's Hospital

Boston, Massachusetts 02115

United States

Children's Mercy Hospitals and Clinics

Kansas City, Missouri 64108

United States

Northwell Health Cohen Children's Medical Center

New York, New York 11042

United States

Duke University Hospital

Durham, North Carolina 27710

United States

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania 19104

United States

Vanderbilt Children's Hospital Neurology

Nashville, Tennessee 37232

United States

Texas Tech University Health Sciences Center Amarillo

Amarillo, Texas 79106

United States

Monash Medical Centre Clayton

Clayton, 3168

Australia

The Royal Children's Hospital (RCH)

Parkville, 3052

Australia

Children's Hospital Westmead Centre for Kidney Research

Westmead, 2145

Australia

Universitair Ziekenhuis Gent

Ghent, 9000

Belgium

UZ Leuven

Leuven, 3000

Belgium

Helsingin Yliopistollinen Keskussairaala Uusi Lastensairaala

Helsinki, 00290

Finland

CHRU Montpellier - Arnaud de Villeneuve

Montpellier, 34090

France

Assistance Publique-Hopitaux de Paris Robert-Debre

Paris, 75019

France

Hôpital des Enfants - Toulouse

Toulouse, 31300

France

Ippokratio Thessaloniki General Hospital

Thessaloniki, Thessaloniki

Greece

Pan and Aglaia Kyriakou Children's Hospital

Athens,

Greece

Shaare Zedek Medical Center

Jerusalem, 9103102

Israel

Schneider Children's Medical Center of Israel

Petach Tikvah, 4920235

Israel

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, 20122

Italy

IRCCS Ospedale Pediatrico Bambino Gesù

Rome, 00165

Italy

Helse Bergen HF Haukeland Universitetssjukehus

Bergen, 5009

Norway

Uniwersytecki Szpital Kliniczny we Wrocławiu

Wroclaw, 50-369

Poland

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

Porto, 4050-342

Portugal

Sidra Medicine

Doha,

Qatar

Spitalul Clinic de Urgenta pentru Copii Louis Turcanu Timisoara

Timișoara, 300011

Romania

King Saud University

Riyadh, 11451

Saudi Arabia

King Faisal Specialist Hospital & Research Centre

Riyadh, 12713

Saudi Arabia

King Abdulaziz Medical City

Riyadh, 14611

Saudi Arabia

Al Jalila Children's Hospital

Dubai,

United Arab Emirates