RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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)

Quick Facts

Study Start:2025-04-06

Study Completion:2030-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05766839

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 11 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Contacts and Locations

Study Contact

EMERALD-2 Clinical Study Team

CONTACT

+41 58 851 80 00

clinicaltrials@cslbehring.com

Principal Investigator

Julian Platon, MD, PhD

STUDY_DIRECTOR

Vifor Pharma, Inc.

Study Locations (Sites)

Children's Hospital Colorado Site 84014

Aurora, Colorado, 80045

United States

UF Health Pediatric Multispecialty Center Site 84006

Jacksonville, Florida, 32207

United States

Miller School of Medicine, University of Miami Site 84003

Miami, Florida, 33124

United States

Arnold Palmer Hospital for Children Site 84010

Orlando, Florida, 32806

United States

Augusta University - Children's Hospital of Georgia Site 84015

Augusta, Georgia, 30912

United States

University of Illinois College of Medicine Site 84012

Peoria, Illinois, 61605

United States

Boston Children's Hospital Site 84008

Boston, Massachusetts, 02115

United States

Children's Mercy Hospitals and Clinics Site 84004

Kansas City, Missouri, 64108

United States

Duke University Hospital & Medical Center Site 84002

Durham, North Carolina, 27710

United States

Duke University Hospital Site 84002

Durham, North Carolina, 27710

United States

The Children's Hospital of Philadelphia Site 84007

Philadelphia, Pennsylvania, 19104

United States

Vanderbilt Children's Hospital Neurology Site 84013

Nashville, Tennessee, 37232

United States

Texas Tech University Health Sciences Center Amarillo Site 84009

Amarillo, Texas, 79106

United States

Collaborators and Investigators

Sponsor: Vifor Pharma, Inc.

Julian Platon, MD, PhD, STUDY_DIRECTOR, Vifor Pharma, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-06

Study Completion Date2030-12

Study Record Updates

Study Start Date2025-04-06

Study Completion Date2030-12

Terms related to this study

Additional Relevant MeSH Terms

Hyperkalemia