Pharmacodynamic & Safety of Patiromer in Children & Adolescents (2-<18 Yrs) With Chronic Kidney Disease and Hyperkalemia

• Register: ClinicalTrials.gov
• Last refreshed on: 31 October 2022
• Main ID: NCT03087058
• Date of registration: 16/03/2017
• Prospective Registration: Yes
• Primary sponsor: Vifor Pharma, Inc.
• Public title: Pharmacodynamic & Safety of Patiromer in Children & Adolescents (2-<18 Yrs) With Chronic Kidney Disease and Hyperkalemia EMERALD
• Scientific 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
• Date of first enrolment: July 7, 2017
• Target sample size: 23
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03087058
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Bulgaria, Canada, Georgia, Germany, Poland, South Africa, Ukraine, United States

Contacts

• Name: Julian Platon, MD, PhD
• Affiliation: Vifor Pharma, Inc.

Key inclusion & exclusion criteria

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 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

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



Age minimum: 2 Years
Age maximum: 17 Years
Gender: All

Health Condition(s) or Problem(s) studied

Hyperkalemia

Intervention(s)

Drug: Patiromer

Primary Outcome(s)

Change in Serum Potassium Levels [Time Frame: from Baseline to Day 14]

Secondary Outcome(s)

Proportion of Subjects With Serum Potassium Levels in the Range of 3.8 - 5.0 mEq/L [Time Frame: Day 14 and Week 26]

Secondary ID(s)

2016-002785-31

RLY5016-206p

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 26/09/2022
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03087058