Pharmacodynamic & Safety of Patiromer in Children & Adolescents (2-<18 Yrs) With Chronic Kidney Disease and Hyperkalemia (EMERALD)
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ClinicalTrials.gov Identifier: NCT03087058 |
Recruitment Status :
Recruiting
First Posted : March 22, 2017
Last Update Posted : February 8, 2021
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Condition or disease | Intervention/treatment | Phase |
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Hyperkalemia | Drug: Patiromer | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 54 participants |
Allocation: | Non-Randomized |
Intervention Model: | Sequential Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | May 1, 2017 |
Estimated Primary Completion Date : | September 2022 |
Estimated Study Completion Date : | September 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: Cohort 1
Patiromer for age 12 - < 18 years
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Drug: Patiromer
4.2 g/day, 8.4 g/day and 16.8 g/day
Other Names:
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Experimental: Cohort 2
Patiromer for age 6 - < 12 years
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Drug: Patiromer
2 g/day, 4 g/day and 8 g/day
Other Names:
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Experimental: Cohort 3
Patiromer for age 2 - < 6 years
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Drug: Patiromer
1 g/day, 2 g/day and 4 g/day
Other Names:
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- Change in serum potassium levels from Baseline to Day 14 [ Time Frame: Baseline and Day 14 ]Changes in serum potassium levels will be summarized by starting dose and age group using descriptive statistics. Descriptive statistics include mean, standard deviation, and 95% confidence intervals.
- Proportion of subjects with serum K+ levels in the range of 3.8 - 5.0 mEq/L at Day 14 (Initial PD / Dose Finding Phase) [ Time Frame: Day 14 ]Proportions and associated exact 95% confidence interval will be presented.
- Proportion of subjects with serum K+ levels in the range of 3.8 - 5.0 mEq/L by visit at any time through Month 6 (Long-Term Treatment Phase) [ Time Frame: Up to Month 6 ]Proportions and associated 95% confidence interval will be presented.

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Ages Eligible for Study: | 2 Years to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 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
Exclusion Criteria:
- 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)
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03087058
Contact: Head of Clinical Operations | 650-421-9500 | emerald@relypsa.com |

Study Director: | Study Director or VP Clinical Development | Relypsa, Inc. |
Responsible Party: | Relypsa, Inc. |
ClinicalTrials.gov Identifier: | NCT03087058 |
Other Study ID Numbers: |
RLY5016-206p 2016-002785-31 ( EudraCT Number ) |
First Posted: | March 22, 2017 Key Record Dates |
Last Update Posted: | February 8, 2021 |
Last Verified: | February 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Treatment of Hyperkalemia Hyperkalemia Potassium Chronic Kidney Disease |
Kidney Diseases Renal Insufficiency, Chronic Hyperkalemia Urologic Diseases |
Renal Insufficiency Water-Electrolyte Imbalance Metabolic Diseases |