Hyperkalemia

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

NCT05766839 | PHASE 2 | INTERVENTIONAL

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

36 Sites

32 Participants

RECRUITING

to 11 Years

If interested, contact clinicaltrials@cslbehring.com or +1 610-878-4697 for more information

CSL Behring respects your privacy. For an explanation of how CSL Behring will use the information you are submitting, please view our Privacy Policy

Find closest sites:

SUBMIT

Children's Hospital Colorado Site

Aurora,Colorado,United States,80045

UF Health Pediatric Multispecialty Center Site

Jacksonville,Florida,United States,32207

Miller School of Medicine, University of Miami Site

Miami,Florida,United States,33124

Arnold Palmer Hospital for Children Site

Orlando,Florida,United States,32806

Augusta University Children's Hospital of Georgia Site

Augusta,Georgia,United States,30912

University of Illinois College of Medicine Site

Peoria,Illinois,United States,61605

Boston Children's Hospital Site

Boston,Massachusetts,United States,02115

Children's Mercy Hospitals and Clinics Site

Kansas City,Missouri,United States,64108

Duke University Hospital & Medical Center Site

Durham,North Carolina,United States,27710

Duke University Hospital Site

Durham,North Carolina,United States,27710

The Children's Hospital of Philadelphia Site

Philadelphia,Pennsylvania,United States,19104

Vanderbilt Children's Hospital Neurology Site

Nashville,Tennessee,United States,37232

Texas Tech University Health Sciences Center Amarillo Site

Amarillo,Texas,United States,79106

The Royal Children's Hospital (RCH) Site

Parkville,Texas,Australia,3052

Children's Hospital Westmead Centre for Kidney Research Site

Westmead,Texas,Australia,2145

Universitair Ziekenhuis Gent Site

Ghent,Texas,Belgium,9000

UZ Leuven Site

Leuven,Texas,Belgium,3000

Helsingin Yliopistollinen Keskussairaala Uusi Lastensairaala Site

Helsinki,Texas,Finland,00290

CHRU Montpellier Arnaud de Villeneuve Site

Montpellier,Texas,France,34090

Assistance PubliqueHopitaux de Paris RobertDebre Site

Paris,Texas,France,75019

Hpital des Enfants Toulouse Site

Toulouse,Texas,France,31300

Ippokratio Thessaloniki General Hospital Site

Thessaloniki,Thessaloniki,Greece,31300

Pan and Aglaia Kyriakou Children's Hospital Site

Athens,Thessaloniki,Greece,31300

Shaare Zedek Medical Center Site

Jerusalem,Thessaloniki,Israel,9103102

Schneider Children's Medical Center of Israel Site

Petach Tikvah,Thessaloniki,Israel,4920235

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Site

Milan,Thessaloniki,Italy,20122

IRCCS Ospedale Pediatrico Bambino Ges Site

Rome,Thessaloniki,Italy,00165

Helse Bergen HF Haukeland Universitetssjukehus Site

Bergen,Thessaloniki,Norway,5009

Uniwersytecki Szpital Kliniczny we Wrocawiu Site

Wroclaw,Thessaloniki,Poland,50-369

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

Porto,Thessaloniki,Portugal,4050-342

Sidra Medicine Site

Doha,Thessaloniki,Qatar,4050-342

Spitalul Clinic de Urgenta pentru Copii Louis Turcanu Timisoara Site

Timișoara,Thessaloniki,Romania,300011

King Saud University Site

Riyadh,Thessaloniki,Saudi Arabia,11451

King Faisal Specialist Hospital & Research Centre Site

Riyadh,Thessaloniki,Saudi Arabia,12713

King Abdulaziz Medical City Site

Riyadh,Thessaloniki,Saudi Arabia,14611

Al Jalila Children's Hospital Site

Dubai,Thessaloniki,United Arab Emirates,14611

Study Eligibility Criteria

Inclusion Criteria

The following inclusion criteria must be met for each participant:
* 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

The following criteria exclude a participant from participating in this trial:
* 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 hypersensiti

Additional Studies

Additional studies can be found at ClinicalTrials.gov