HyperkalemiaPhase 2EMERALD2NCT05766839
Effect of Patiromer in Children Under 12 Years of Age With High Blood Potassium Levels
A Phase 2 study testing Patiromer in people with Hyperkalemia, run by Vifor Pharma, Inc. at 37 sites in 15 countries.
Trial summary
A study to evaluate the pharmacodynamic effects, safety, and tolerability of patiromer in children under 12 years of age with hyperkalaemia. Read more about this study
- Who is it for?
- Ages 0 to 11 years
- Conditions the study is for
- Hyperkalemia
- What is being tested?
- Patiromer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 37 sitesin 15 countries
- Study dates
- 6 Apr 2025to 1 Dec 2030
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
- In continuation to above criterion: At least 1 sample needs to be taken at screening/baseline and 1 sample should not be older than 30 days, i.e., a historical sample. The average of the 2 potassium values needs to be above the age-appropriate ULN of the measurement method plus 0.5 mEq/l (equivalent to 0.5 mmol/l). If the 2 samples are taken on the day of screening/baseline, the 2 individual potassium values must not differ from each other by more than 0.5 mEq/l.
- In the opinion of the Investigator, the participant is expected to require treatment for hyperkalaemia for at least 28 days upon enrolment in the study.
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- 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 acceptable representative(s) has provided the appropriate written informed consent, in accordance with local regulations. The assent of the child should also be obtained when appropriate or if requested by the Institutional Review Board (IRB)/Ethics Committee (EC)/Independent Ethics Committee (IEC). The written informed consent must be provided before any study specific procedures are performed including screening procedures.
- 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 according to the Schedule of Events (Table 1, Table 2) (e.g., able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures); accurately and reliably dispense investigational product as directed.
- Not applicable to Norway sites: 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.
- For participants who have undergone organ transplantation, the general clinical condition must be stable for at least 4 weeks prior to Screening and is not expected to change during the first 4 weeks of the study.
- For participants who have undergone organ transplantation, must have persistent hyperkalaemia requiring potassium-lowering therapy despite correction of reversible causes (e.g., high calcineurin inhibitor levels).
Who cannot join
- 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 as specified in the Schedule of Events.
- Participants with pseudo-hyperkalaemia due to haemolysis or to abnormally high numbers of platelets (above ULN), leukocytes (above ULN), or erythrocytes (above ULN) at screening based on results obtained from the local laboratory.
- Any participant with evidence of potential potassium-related 12-lead electrocardiogram (ECG) changes (i.e., changes consistent with hyper- or hypokalaemia) at screening.
- Any participant with serum magnesium <1.4 mg/dl (0.58 mmol/l) at screening/baseline.
- 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.
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- 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.
- In continuation to above criterion: 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.
- Liver enzymes (alanine aminotransferase or aspartate aminotransferase) more than 3 times the ULN at screening, based on the local laboratory, as well as the participant's respective age.
- 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).
- Has severe hypoxaemia, respiratory acidosis, asphyxia, or hypotension 3 months before screening based on assessment of the Investigator.
- Participants treated with sodium polystyrene sulphonate, calcium polystyrene sulphonate, sodium zirconium cyclosilicate, or patiromer within the last 48 hours prior to fulfilling the baseline baseline potassium assessments requested in 4th Inclusion Criterion.
- 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.
- In the opinion of the Investigator, parent(s) or legal representative(s) inability to comply with the protocol.
- In the opinion of the Investigator, any medical condition, uncontrolled systemic disease, or serious intercurrent illness that would significantly decrease study compliance or jeopardise the safety of the participant or potentially affect the quality of the data such as:
- In continuation to above criterion: hyperkalaemia at screening that requires emergency intervention; cardiovascular event or intervention within 3 months prior to screening; a haemodynamically unstable arrhythmia; hospitalisation for heart failure within the past 3 months; poorly controlled blood pressure; poorly controlled diabetes mellitus or frequent need for adjustment in insulin prescription or recent hospitalisation for treatment of hyper or hypoglycaemia.
- If the child is being breastfed:
- There is suspicion of current alcohol or substance misuse/abuse in breastfeeding mother.
- The breastfeeding mother is taking potassium supplements
Trial locations and contacts
37 sites in 15 countries. Contact the study team or a site near you to ask about taking part.
37 sites in 15 countries
United States13 sites, 11 recruiting
- Terminated
Texas Tech University Health Sciences Center Amarillo
Amarillo, Texas, 79106
- Recruiting
Augusta University - Children's Hospital of Georgia
Augusta, Georgia, 30912
- Recruiting
Children's Hospital Colorado
Aurora, Colorado, 80045
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
- Recruiting
Duke University Hospital
Durham, North Carolina, 27710
- Terminated
UF Health Pediatric Multispecialty Center Site
Jacksonville, Florida, 32207
- Recruiting
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, 64108
- Recruiting
Miller School of Medicine, University of Miami
Miami, Florida, 33124
- Recruiting
Vanderbilt Children's Hospital Neurology
Nashville, Tennessee, 37232
- Not yet recruiting
Northwell Health Cohen Children's Medical Center
New York, New York, 11042
- Recruiting
Arnold Palmer Hospital for Children
Orlando, Florida, 32806
- Recruiting
University of Illinois College of Medicine
Peoria, Illinois, 61605
- Recruiting
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Australia3 sites, 3 recruiting
- Recruiting
Monash Medical Centre Clayton
Clayton, 3168
- Recruiting
The Royal Children's Hospital (RCH)
Parkville, 3052
- Recruiting
Children's Hospital Westmead Centre for Kidney Research
Westmead, 2145
France3 sites, 3 recruiting
- Recruiting
CHRU Montpellier - Arnaud de Villeneuve
Montpellier, 34090
Central Contact
- Recruiting
Assistance Publique-Hopitaux de Paris Robert-Debre
Paris, 75019
Central Contact
- Recruiting
Hôpital des Enfants - Toulouse
Toulouse, 31300
Saudi Arabia3 sites, 3 recruiting
- Recruiting
King Saud University
Riyadh, 11451
- Recruiting
King Faisal Specialist Hospital & Research Centre
Riyadh, 12713
- Recruiting
King Abdulaziz Medical City
Riyadh, 14611
Belgium2 sites, 2 recruiting
- Recruiting
Universitair Ziekenhuis Gent
Ghent, 9000
Central Contract
- Recruiting
UZ Leuven
Leuven, 3000
Greece2 sites, 2 recruiting
- Recruiting
Pan and Aglaia Kyriakou Children's Hospital
Athens
Central Contact
- Recruiting
Ippokratio Thessaloniki General Hospital
Thessaloniki, Thessaloniki
Central Contract
Israel2 sites, 2 recruiting
- Recruiting
Shaare Zedek Medical Center
Jerusalem, 9103102
- Recruiting
Schneider Children's Medical Center of Israel
Petach Tikvah, 4920235
Italy2 sites, 2 recruiting
- Recruiting
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, 20122
- Recruiting
IRCCS Ospedale Pediatrico Bambino Gesù
Rome, 00165
Finland1 site, 1 recruiting
- Not yet recruiting
Helsingin Yliopistollinen Keskussairaala Uusi Lastensairaala
Helsinki, 00290
Norway1 site, 1 recruiting
- Recruiting
Helse Bergen HF Haukeland Universitetssjukehus
Bergen, 5009
Poland1 site, 1 recruiting
- Not yet recruiting
Uniwersytecki Szpital Kliniczny we Wrocławiu
Wroclaw, 50-369
Portugal1 site, 1 recruiting
- Recruiting
Unidade Local de Saude de Santo Antonio, E.P.E.
Porto, 4050-342
Romania1 site, 1 recruiting
- Recruiting
Spitalul Clinic de Urgenta pentru Copii Louis Turcanu Timisoara
Timișoara, 300011
United Arab Emirates1 site, 1 recruiting
- Recruiting
Al Jalila Children's Hospital
Dubai
About this study
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)
A study to evaluate the pharmacodynamic effects, safety, and tolerability of patiromer in children under 12 years of age with hyperkalaemia.
- Conditions
- Hyperkalemia
- Being tested
- Patiromer
- Medical subject headings
- Hyperkalemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PatiromerDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Patiromer | Experimental | 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. Receives: Drug: Patiromer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in potassium levels (mmol/L)
May be measured as serum, plasma, whole blood, potassium
Measured: From baseline to Day 28
Secondary outcomes (26)
Change in potassium levels (mmol/L)
May be measured as serum, plasma, whole blood, potassium
Measured: From baseline to Day 3, Day 7, Day 14, Day 28, and during Part 2: up to 52 weeks
Occurrence of treatment-emergent adverse events (TEAEs)
Measured: Part 1: Day 1 up to end of treatment (Day 28 ±3 Days); Part 2: Day 1 up to follow-up visit (Up to 54 weeks)
Occurrence of serious adverse events (SAEs)
Measured: Part 1: Day 1 up to end of treatment (Day 28 ±3 Days); Part 2: Day 1 up to follow-up visit (Up to 54 weeks)
Change from baseline in resting heart rate (beats per minute)
Measured: From baseline to Day 3, Day 7, Day 14, Day 28, and during Part 2: up to 52 weeks
Change from baseline in systolic blood pressure (mmHg)
Measured: From baseline to Day 3, Day 7, Day 14, Day 28, and during Part 2: up to 52 weeks
Change from baseline in diastolic blood pressure (mmHg)
Measured: From baseline to Day 3, Day 7, Day 14, Day 28, and during Part 2: up to 52 weeks
Change from baseline in body temperature (Celsius)
Measured: From baseline to Day 3, Day 7, Day 14, Day 28, and during Part 2: up to 52 weeks
Number of patients with ECG abnormalities
Measured: From baseline to Day 3, Day 7, Day 14, Day 28, and during Part 2: up to 52 weeks
Change from baseline in chemistry laboratory evaluation: Calcium (mg/dL)
Measured: From baseline to Day 3, Day 7, Day 14, Day 28, and during Part 2: up to 52 weeks
Change from baseline in chemistry laboratory evaluation: Phosphate (mg/dL)
Measured: From baseline to Day 3, Day 7, Day 14, Day 28, and during Part 2: up to 52 weeks
Change from baseline in chemistry laboratory evaluation: Magnesium (mg/dL)
Measured: From baseline to Day 3, Day 7, Day 14, Day 28, and during Part 2: up to 52 weeks
Change from baseline in chemistry laboratory evaluation: Potassium (mEq/L)
Measured: From baseline to Day 3, Day 7, Day 14, Day 28, and during Part 2: up to 52 weeks
Change from baseline in chemistry laboratory evaluation: Sodium (mEq/L)
Measured: From baseline to Day 3, Day 7, Day 14, Day 28, and during Part 2: up to 52 weeks
Change from baseline in chemistry laboratory evaluation: Creatinine (mg/dL)
Measured: From baseline to Day 3, Day 7, Day 14, Day 28, and during Part 2: up to 52 weeks
Change from baseline in chemistry laboratory evaluation: Serum bicarbonate (mEq/L)
Measured: From baseline to Day 3, Day 7, Day 14, Day 28, and during Part 2: up to 52 weeks
Change from baseline in chemistry laboratory evaluation: Blood urea nitrogen (mEq/L)
Measured: From baseline to Day 3, Day 7, Day 14, Day 28, and during Part 2: up to 52 weeks
Change from baseline in haematology laboratory evaluation: White blood cells (10^9/L)
Measured: From baseline to Day 7, Day 14, Day 28, and EoT visit for Part 2 (week 52)
Change from baseline in haematology laboratory evaluation: Red blood cells count (10^12/L)
Measured: From baseline to Day 7, Day 14, Day 28, and EoT visit for Part 2 (week 52)
Change from baseline in haematology laboratory evaluation: Haemoglobin (10^12/L)
Measured: From baseline to Day 7, Day 14, Day 28, and EoT visit for Part 2 (week 52)
Change from baseline in haematology laboratory evaluation: Haematocrit (%)
Measured: From baseline to Day 7, Day 14, Day 28, and EoT visit for Part 2 (week 52)
Change from baseline in haematology laboratory evaluation: Platelet count (10^9/L)
Measured: From baseline to Day 7, Day 14, Day 28, and EoT visit for Part 2 (week 52)
Change from baseline in haematology laboratory evaluation: Blood fluoride (ng/mL)
Measured: From baseline to Day 7, Day 14, Day 28, and EoT visit for Part 2 (week 52)
Occurrence of blood potassium below the lower limit of normal (LLN) (mmol/L)
Measured: Part 1: Screening up to end of treatment (Day 28 ±3 Days); Part 2: Day 1 up to end of treatment (Up to 52 weeks)
Occurrence of blood potassium above the upper limit of normal (ULN) (mmol/L)
Measured: Part 1: Screening up to end of treatment (Day 28 ±3 Days); Part 2: Day 1 up to end of treatment (Up to 52 weeks)
Occurrence of blood magnesium at levels specified in protocol (mmol/L)
Measured: Part 1: Screening up to end of treatment (Day 28 ±3 Days); Part 2: Day 1 up to end of treatment (Up to 52 weeks)
Occurrence of abnormal clinical laboratory value findings
Occurrence of clinical laboratory value findings that are outside of normal range of the respective age for: serum calcium, phosphate, fluoride, creatinine, bicarbonate, and blood urea nitrogen levels
Measured: Part 1: Screening up to end of treatment (Day 28 ±3 Days); Part 2: Day 1 up to end of treatment (Up to 52 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start6 Apr 2025
- Primary completion1 Dec 2029 (estimated)
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperkalemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vifor Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Julian Platon, MD, PhD, Study director, Vifor Pharma, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05766839
- Sponsor's protocol ID
- RLY5016-208p
- Other IDs
- 2023-505252-21-00, 2023
- Acronym
- EMERALD2
- Status last verified
- Sep 2026
- First submitted
- 19 Jan 2023
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: CSL will consider on a case-by-case basis requests to share Individual Patient Data (IPD) with external bona-fide, qualified scientific and medical researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.