HyperkalemiaPhase 2EMERALDNCT03087058
Pharmacodynamic & Safety of Patiromer in Children & Adolescents (2-<18 Yrs) With Chronic Kidney Disease and Hyperkalemia
A Phase 2 study testing Patiromer in people with Hyperkalemia, run by Vifor Pharma, Inc. at 30 sites in 7 countries.
Trial summary
The purpose of this study is to evaluate the change in serum potassium levels from start of treatment to Day 14, when patiromer is administered at different doses, once daily, in children 2 - < 18 years of age with chronic kidney disease (CKD) and hyperkalemia (too much potassium in the blood). Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Hyperkalemia
- What is being tested?
- Patiromer
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 30 sitesin 7 countries
- Study dates
- 7 Jul 2017to 30 Apr 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Written assent (when applicable) and written informed consent by a legally authorized representative provided prior to participation in the study
- Age 2 - <18 years old
- CKD defined by the estimated glomerular filtration rate (eGFR) <90 mL/min/1.73m2, including renal transplant subjects, based on local creatinine measurement at screening
- Two potassium measurements of 5.1 to < 6.5 mEq/L performed on separate days
- In the opinion of the study doctor, is expected to require treatment for hyperkalemia for at least 6 month
- If taking any renin-angiotensin-aldosterone system inhibitors (RAASi) beta blockers or diuretic medications, must be on a stable dose for at least 28 days prior to Screening
- Negative pregnancy test in females of child-bearing potential
Who cannot join
- Pseudohyperkalemia due to hemolysis or to abnormally high numbers of platelets (>500,000/mm3), leukocytes (>70,000/mm3), or erythrocytes (hematocrit >55%) at Screening based on results obtained locally
- Evidence of potassium-related electrocardiogram (ECG) changes at Screening
- Any of the following kidney conditions: maintenance hemodialysis or peritoneal dialysis, renal artery stenosis, and acute kidney injury or a history of acute renal insufficiency in the past 3 months
- Severe disorder of stomach or intestines including surgery that could affect gastrointestinal transit of the drug
- Increased liver enzymes (ALT, AST > 3 times upper limit of normal) at Screening
- Active cancer, currently on cancer treatment or history of cancer in the past 2 years (except for non-melanoma skin cancer)
Show all 13Show fewer
- Heart or liver transplant, or anticipated need for transplant during the study treatment period including a scheduled kidney transplant recipient. (Note: patients currently on a kidney transplant wait list are not excluded unless there is an identified donor).
- Alcohol abuse or substance use disorder within 1 year of Screening
- Subjects currently being treated with or having taken any one of the following medications (includes resins) in the 7 days prior to Screening: sodium or calcium polystyrene sulfonate, drospirenone
- Use of certain medications that can affect blood potassium levels if doses have not been stable for at least 14 days prior to Screening or if doses are anticipated to change during the 14-day PD / Dose Finding Phase
- Use of investigational product within 30 days of screening or within 5 half-lives, whichever is longer
- Known hypersensitivity to patiromer or its components
- In the opinion of the Investigator, any medical condition, uncontrolled systemic disease, or serious intercurrent illness that would significantly decrease study compliance or jeopardize the safety of the subject or potentially affect the quality of the data
Trial locations and contacts
30 sites in 7 countries.
30 sites in 7 countries
United States10 sites
Investigator Site 1104
Amarillo, Texas, 79106
Investigator Site 1103
Baltimore, Maryland, 21287
Investigator Site 1105
Cincinnati, Ohio, 45229
Investigator Site 1109
Dallas, Texas, 75235
Investigator Site 1113
Houston, Texas, 77030
Investigator Site 1101
Kansas City, Kansas, 64108
Investigator Site 1106
Madison, Wisconsin, 53792
Investigator Site 1107
Palo Alto, California, 94394
Investigator Site 1108
Pittsburgh, Pennsylvania, 15224
Investigator Site 1102
The Bronx, New York, 10467
Poland6 sites
Investigator Site 5401
Bialystok, 15-274
Investigator Site 5404
Gdansk, 80-952
Investigator Site 5406
Krakow, 30-663
Investigator Site 5402
Lodz, 93-338
Investigator Site 5403
Lublin, 20-093
Investigator Site 5405
Warsaw, 02-091
Georgia5 sites
Investigator Site 3915
Tbilisi, 0121
Investigator Site 3913
Tbilisi, 0144
Investigator Site 3911
Tbilisi, 0159
Investigator Site 3912
Tbilisi, 0159
Investigator Site 3914
Tbilisi, 0159
Germany4 sites
Investiagor Site 4314
Cologne, 50937
Investigator Site 4312
Essen, 45147
Investigator Site 4313
Hanover, 30625
Investigator Site 4311
Heidelberg, 69120
Ukraine3 sites
Investigator Site 7906
Dnipro, 49000
Investigator Site 7903
Kharkiv, 61075
Investigator Site 7904
Kyiv, 04050
About this study
Official title: A Phase 2, Open-Label, Multiple Dose Study to Evaluate the Pharmacodynamic Effects, Safety, and Tolerability of Patiromer for Oral Suspension in Children and Adolescents 2 to < 18 Years of Age With Chronic Kidney Disease and Hyperkalemia
The purpose of this study is to evaluate the change in serum potassium levels from start of treatment to Day 14, when patiromer is administered at different doses, once daily, in children 2 - < 18 years of age with chronic kidney disease (CKD) and hyperkalemia (too much potassium in the blood). Another purpose of the study is to evaluate the safety and tolerability of patiromer in children 2 - < 18 years of age with CKD and hyperkalemia.
Read the detailed description
Up to 54 subjects, 2 - < 18 years of age with CKD (estimated glomerular filtration rate [eGFR] < 90 mL/min/1.73 m2 ) and hyperkalemia (two potassium measurements of 5.1 to < 6.5 mEq/L performed on separate days) will be enrolled in this open-label, multiple-dose, Phase 2 study.
The study will include two treatment phases: Pharmacodynamic (PD; drug effect on potassium) / Dose Finding Phase consisting of the initial 14-day dose finding period followed by an up to 5.5-month Long-Term Treatment Phase for a total study participation duration for individual subjects of up to 6.5 months (includes a 2 week follow up period).
- Conditions
- Hyperkalemia
- Being tested
- Patiromer
- Keywords
- Treatment of Hyperkalemia, Hyperkalemia, Potassium, Chronic Kidney Disease
- Medical subject headings
- Hyperkalemia, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PatiromerDrug
Also called Veltassa, RLY5016 for Oral Suspension
4.2 g/day, 8.4 g/day and 16.8 g/day
PatiromerDrug
Also called Veltassa, RLY5016 for Oral Suspension
2 g/day, 4 g/day and 8 g/day
PatiromerDrug
Also called Veltassa, RLY5016 for Oral Suspension
1 g/day, 2 g/day and 4 g/day
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Patiromer for age 12 to < 18 years Receives: Drug: Patiromer |
| Cohort 2 | Experimental | Patiromer for age 6 to < 12 years Receives: Drug: Patiromer |
| Cohort 3 | Experimental | Patiromer for age 2 to < 6 years Receives: Drug: Patiromer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Serum Potassium Levels
Measured: from Baseline to Day 14
Secondary outcomes (1)
Proportion of Subjects With Serum Potassium Levels in the Range of 3.8 - 5.0 mEq/L
Day 14: Initial PD / Dose Finding Phase. Week 26: Long-Term Treatment Phase.
Measured: Day 14 and Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2017
- Study start7 Jul 2017
- Primary completion13 Jan 2021
- Study completion30 Apr 2021
Why it stopped: The study was terminated on 13 May 2022 due to a modification to the PIP/PSP
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
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
- NCT03087058
- Sponsor's protocol ID
- RLY5016-206p
- Other IDs
- 2016-002785-31, 2016
- Acronym
- EMERALD
- Status last verified
- Oct 2022
- First submitted
- 16 Mar 2017
- Last updated
- 19 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-Label, Multiple Dose Study to Evaluate the Pharmacodynamic Effects, Safety, and Tolerability of Patiromer for Oral Suspension in Children and Adolescents 2 to < 18 Years of Age With Chronic Kidney Disease and Hyperkalemia
- ClinicalTrials.gov ID
- NCT03087058
- Acronym / sponsor ID
- EMERALD / RLY5016-206p
- Conditions
- Hyperkalemia
- Keywords
- Treatment of Hyperkalemia, Hyperkalemia, Potassium, Chronic Kidney Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated on 13 May 2022 due to a modification to the PIP/PSP
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Vifor Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Jul 2017 (actual)
- Primary completion
- 13 Jan 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 22 Mar 2017 (actual)
- Results
- Posted 26 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the change in serum potassium levels from start of treatment to Day 14, when patiromer is administered at different doses, once daily, in children 2 - < 18 years of age with chronic kidney disease (CKD) and hyperkalemia (too much potassium in the blood). Another purpose of the study is to evaluate the safety and tolerability of patiromer in children 2 - < 18 years of age with CKD and hyperkalemia.
Detailed description
Up to 54 subjects, 2 - < 18 years of age with CKD (estimated glomerular filtration rate [eGFR] < 90 mL/min/1.73 m2 ) and hyperkalemia (two potassium measurements of 5.1 to < 6.5 mEq/L performed on separate days) will be enrolled in this open-label, multiple-dose, Phase 2 study.
The study will include two treatment phases: Pharmacodynamic (PD; drug effect on potassium) / Dose Finding Phase consisting of the initial 14-day dose finding period followed by an up to 5.5-month Long-Term Treatment Phase for a total study participation duration for individual subjects of up to 6.5 months (includes a 2 week follow up period).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: PatiromerPatiromer for age 12 to < 18 years |
| Cohort 2 | Experimental | Drug: PatiromerPatiromer for age 6 to < 12 years |
| Cohort 3 | Experimental | Drug: PatiromerPatiromer for age 2 to < 6 years |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Written assent (when applicable) and written informed consent by a legally authorized representative provided prior to participation in the study
- Age 2 - <18 years old
- CKD defined by the estimated glomerular filtration rate (eGFR) <90 mL/min/1.73m2, including renal transplant subjects, based on local creatinine measurement at screening
- Two potassium measurements of 5.1 to < 6.5 mEq/L performed on separate days
- In the opinion of the study doctor, is expected to require treatment for hyperkalemia for at least 6 month
Key exclusion criteria (13 listed)
- Pseudohyperkalemia due to hemolysis or to abnormally high numbers of platelets (>500,000/mm3), leukocytes (>70,000/mm3), or erythrocytes (hematocrit >55%) at Screening based on results obtained locally
- Evidence of potassium-related electrocardiogram (ECG) changes at Screening
- Any of the following kidney conditions: maintenance hemodialysis or peritoneal dialysis, renal artery stenosis, and acute kidney injury or a history of acute renal insufficiency in the past 3 months
- Severe disorder of stomach or intestines including surgery that could affect gastrointestinal transit of the drug
- Increased liver enzymes (ALT, AST > 3 times upper limit of normal) at Screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PatiromerAlso: Veltassa, RLY5016 for Oral Suspension4.2 g/day, 8.4 g/day and 16.8 g/day | Drug | Cohort 1 |
| PatiromerAlso: Veltassa, RLY5016 for Oral Suspension2 g/day, 4 g/day and 8 g/day | Drug | Cohort 2 |
| PatiromerAlso: Veltassa, RLY5016 for Oral Suspension1 g/day, 2 g/day and 4 g/day | Drug | Cohort 3 |
Primary outcome
Change in Serum Potassium Levels
Time frame: from Baseline to Day 14
1 secondary outcome
Proportion of Subjects With Serum Potassium Levels in the Range of 3.8 - 5.0 mEq/L
Time frame: Day 14 and Week 26
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Hyperkalemia
Enrolling by invitationObservational study
AK+ Guard™ Pilot Study in Chronic Kidney Disease: Outpatient Diagnostic Accuracy and Remote Monitoring
Hyperkalemia, Chronic Kidney Disease (Stage 3-4)
RecruitingPhase 3
A Phase 3 Study Evaluating the Efficacy and Safety of WS016 for the Treatment of Hyperkalemia
Hyperkalemia
Not yet recruiting
Effects of Minimally vs. Ultra-Processed Diets on Potassium (K) Handling in CKD
Chronic Kidney Disease
Enrolling by invitationPhase 4
Rapid and Simultaneous Initiation of Four Guideline-Directed CKD Therapies (RAPID-CKD)
Chronic Kidney Disease, Type 2 Diabetes
Recruiting
Safety of a Healthy Plant-based Diet With Higher Potassium Content, Compared to a Healthy Plant-based Diet With Limited Potassium Content in Patients With Chronic Kidney Disease: A Pilot Study
Hyperkalemia, Chronic Kidney Disease (Stages 4 and 5)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julian Platon, MD, PhD study director
Vifor Pharma, Inc.
30 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Patiromer in people with Hyperkalemia, run by Vifor Pharma, Inc. at 30 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States, Poland, Georgia, Germany, Ukraine and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Serum Potassium Levels (time frame: from Baseline to Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2022.