Patiromer for Treatment of Hyperkalaemia in Children Under 12 Years of Age
NCT ID: NCT05766839
Last Updated: 2025-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
32 participants
INTERVENTIONAL
2025-04-06
2030-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Patiromer
4-week pharmacodynamic /dose-ranging period
Cohort 1: 6 to less than (\<)12 years of age
Cohort 2: 2 to \<6 years of age
Cohort 3: 0 to \<2 years of age; In Cohort 3, a minimum of 3 study participants will be assessed in the subgroup of 0 to \<6 months and another 3 study participants in the subgroup 6 to \<24 months of age.
Patiromer
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
Interventions
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Patiromer
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
Eligibility Criteria
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Inclusion Criteria
* 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
11 Years
ALL
No
Sponsors
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Vifor Pharma, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Julian Platon, MD, PhD
Role: STUDY_DIRECTOR
Vifor Pharma, Inc.
Locations
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Children's Hospital Colorado Site 84014
Aurora, Colorado, United States
UF Health Pediatric Multispecialty Center Site 84006
Jacksonville, Florida, United States
Miller School of Medicine, University of Miami Site 84003
Miami, Florida, United States
Arnold Palmer Hospital for Children Site 84010
Orlando, Florida, United States
Augusta University - Children's Hospital of Georgia Site 84015
Augusta, Georgia, United States
University of Illinois College of Medicine Site 84012
Peoria, Illinois, United States
Boston Children's Hospital Site 84008
Boston, Massachusetts, United States
Children's Mercy Hospitals and Clinics Site 84004
Kansas City, Missouri, United States
Duke University Hospital & Medical Center Site 84002
Durham, North Carolina, United States
Duke University Hospital Site 84002
Durham, North Carolina, United States
The Children's Hospital of Philadelphia Site 84007
Philadelphia, Pennsylvania, United States
Vanderbilt Children's Hospital Neurology Site 84013
Nashville, Tennessee, United States
Texas Tech University Health Sciences Center Amarillo Site 84009
Amarillo, Texas, United States
The Royal Children's Hospital (RCH) Site 03601
Parkville, , Australia
Children's Hospital Westmead Centre for Kidney Research Site 03602
Westmead, , Australia
Universitair Ziekenhuis Gent Site 05601
Ghent, , Belgium
UZ Leuven Site 05602
Leuven, , Belgium
Helsingin Yliopistollinen Keskussairaala Uusi Lastensairaala Site 24601
Helsinki, , Finland
CHRU Montpellier - Arnaud de Villeneuve Site 25001
Montpellier, , France
Assistance Publique-Hopitaux de Paris Robert-Debre Site 25003
Paris, , France
Hôpital des Enfants - Toulouse Site 25002
Toulouse, , France
Ippokratio Thessaloniki General Hospital Site 30002
Thessaloniki, Thessaloniki, Greece
Pan and Aglaia Kyriakou Children's Hospital Site 30001
Athens, , Greece
Shaare Zedek Medical Center Site 37602
Jerusalem, , Israel
Schneider Children's Medical Center of Israel Site 37601
Petach Tikvah, , Israel
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Site 38002
Milan, , Italy
IRCCS Ospedale Pediatrico Bambino Gesù Site 38001
Rome, , Italy
Helse Bergen HF Haukeland Universitetssjukehus Site 57801
Bergen, , Norway
Uniwersytecki Szpital Kliniczny we Wrocławiu Site 61601
Wroclaw, , Poland
Unidade Local de Saude de Santo Antonio, E.P.E. Site 62001
Porto, , Portugal
Sidra Medicine Site 63401
Doha, , Qatar
Spitalul Clinic de Urgenta pentru Copii Louis Turcanu Timisoara Site 64201
Timișoara, , Romania
King Saud University Site 68202
Riyadh, , Saudi Arabia
King Faisal Specialist Hospital & Research Centre Site 68201
Riyadh, , Saudi Arabia
King Abdulaziz Medical City Site 68203
Riyadh, , Saudi Arabia
Al Jalila Children's Hospital Site 78401
Dubai, , United Arab Emirates
Countries
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Central Contacts
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Facility Contacts
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Central Contract
Role: primary
Central Contact
Role: primary
Central Contact
Role: primary
Central Contract
Role: primary
Central Contact
Role: primary
Other Identifiers
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2023-505252-21-00
Identifier Type: OTHER
Identifier Source: secondary_id
RLY5016-208p
Identifier Type: -
Identifier Source: org_study_id
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