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)

Status: Recruiting
Location: See all (36) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Maximum Age: 11
Healthy Volunteers: f
View:

⁃ 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.

Locations
United States
Colorado
Children's Hospital Colorado Site 84014
NOT_YET_RECRUITING
Aurora
Florida
UF Health Pediatric Multispecialty Center Site 84006
RECRUITING
Jacksonville
Miller School of Medicine, University of Miami Site 84003
RECRUITING
Miami
Arnold Palmer Hospital for Children Site 84010
NOT_YET_RECRUITING
Orlando
Georgia
Augusta University - Children's Hospital of Georgia Site 84015
NOT_YET_RECRUITING
Augusta
Illinois
University of Illinois College of Medicine Site 84012
RECRUITING
Peoria
Massachusetts
Boston Children's Hospital Site 84008
NOT_YET_RECRUITING
Boston
Missouri
Children's Mercy Hospitals and Clinics Site 84004
RECRUITING
Kansas City
North Carolina
Duke University Hospital & Medical Center Site 84002
RECRUITING
Durham
Duke University Hospital Site 84002
RECRUITING
Durham
Pennsylvania
The Children's Hospital of Philadelphia Site 84007
RECRUITING
Philadelphia
Tennessee
Vanderbilt Children's Hospital Neurology Site 84013
NOT_YET_RECRUITING
Nashville
Texas
Texas Tech University Health Sciences Center Amarillo Site 84009
NOT_YET_RECRUITING
Amarillo
Other Locations
Australia
The Royal Children's Hospital (RCH) Site 03601
RECRUITING
Parkville
Children's Hospital Westmead Centre for Kidney Research Site 03602
NOT_YET_RECRUITING
Westmead
Belgium
Universitair Ziekenhuis Gent Site 05601
RECRUITING
Ghent
UZ Leuven Site 05602
NOT_YET_RECRUITING
Leuven
Finland
Helsingin Yliopistollinen Keskussairaala Uusi Lastensairaala Site 24601
NOT_YET_RECRUITING
Helsinki
France
CHRU Montpellier - Arnaud de Villeneuve Site 25001
RECRUITING
Montpellier
Assistance Publique-Hopitaux de Paris Robert-Debre Site 25003
RECRUITING
Paris
Hôpital des Enfants - Toulouse Site 25002
RECRUITING
Toulouse
Greece
Pan and Aglaia Kyriakou Children's Hospital Site 30001
RECRUITING
Athens
Ippokratio Thessaloniki General Hospital Site 30002
RECRUITING
Thessaloniki
Israel
Shaare Zedek Medical Center Site 37602
RECRUITING
Jerusalem
Schneider Children's Medical Center of Israel Site 37601
RECRUITING
Petach Tikvah
Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Site 38002
NOT_YET_RECRUITING
Milan
IRCCS Ospedale Pediatrico Bambino Gesù Site 38001
NOT_YET_RECRUITING
Rome
Norway
Helse Bergen HF Haukeland Universitetssjukehus Site 57801
NOT_YET_RECRUITING
Bergen
Poland
Uniwersytecki Szpital Kliniczny we Wrocławiu Site 61601
NOT_YET_RECRUITING
Wroclaw
Portugal
Unidade Local de Saude de Santo Antonio, E.P.E. Site 62001
NOT_YET_RECRUITING
Porto
Qatar
Sidra Medicine Site 63401
NOT_YET_RECRUITING
Doha
Romania
Spitalul Clinic de Urgenta pentru Copii Louis Turcanu Timisoara Site 64201
RECRUITING
Timișoara
Saudi Arabia
King Abdulaziz Medical City Site 68203
NOT_YET_RECRUITING
Riyadh
King Faisal Specialist Hospital & Research Centre Site 68201
NOT_YET_RECRUITING
Riyadh
King Saud University Site 68202
NOT_YET_RECRUITING
Riyadh
United Arab Emirates
Al Jalila Children's Hospital Site 78401
NOT_YET_RECRUITING
Dubai
Contact Information
Primary
EMERALD-2 Clinical Study Team
clinicaltrials@cslbehring.com
+41 58 851 80 00
Time Frame
Start Date: 2025-04-06
Estimated Completion Date: 2030-12
Participants
Target number of participants: 32
Treatments
Experimental: 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.
Related Therapeutic Areas
Sponsors
Leads: Vifor Pharma, Inc.

This content was sourced from clinicaltrials.gov