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

NCT03087058 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: RLY5016-206p2016-002785-31
• Study Type: interventional
• Target: 23
• Locations: 7 countries
• Sites: 30

Brief 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). 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.

Conditions

Hyperkalemia

Keywords

Treatment of Hyperkalemia; Hyperkalemia; Potassium; Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• Change in Serum Potassium Levels

  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 and Week 26

Study Arms (3)

Cohort 1

EXPERIMENTAL

Patiromer for age 12 to \< 18 years

Drug: Patiromer

Cohort 2

EXPERIMENTAL

Patiromer for age 6 to \< 12 years

Drug: Patiromer

Cohort 3

EXPERIMENTAL

Patiromer for age 2 to \< 6 years

Drug: Patiromer

Interventions

Patiromer DRUG

4.2 g/day, 8.4 g/day and 16.8 g/day

Also known as: Veltassa, RLY5016 for Oral Suspension

Cohort 1

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vifor Pharma, Inc.: lead

Study Sites (30)

Investigator Site 1107

Palo Alto, California, 94394, United States

Location

Investigator Site 1101

Kansas City, Kansas, 64108, United States

Location

Investigator Site 1103

Baltimore, Maryland, 21287, United States

Location

Investigator Site 1102

The Bronx, New York, 10467, United States

Location

Investigator Site 1105

Cincinnati, Ohio, 45229, United States

Location

Investigator Site 1108

Pittsburgh, Pennsylvania, 15224, United States

Location

Investigator Site 1104

Amarillo, Texas, 79106, United States

Location

Investigator Site 1109

Dallas, Texas, 75235, United States

Location

Investigator Site 1113

Houston, Texas, 77030, United States

Location

Investigator Site 1106

Madison, Wisconsin, 53792, United States

Location

Investigator Site 1401

Sofia, 1606, Bulgaria

Location

Investigator Site 1902

Vancouver, British Columbia, V5Z 4H4, Canada

Location

Investigator Site 3915

Tbilisi, 0121, Georgia

Location

Investigator Site 3913

Tbilisi, 0144, Georgia

Location

Investigator Site 3911

Tbilisi, 0159, Georgia

Location

Investigator Site 3912

Tbilisi, 0159, Georgia

Location

Investigator Site 3914

Tbilisi, 0159, Georgia

Location

Investiagor Site 4314

Cologne, 50937, Germany

Location

Investigator Site 4312

Essen, 45147, Germany

Location

Investigator Site 4313

Hanover, 30625, Germany

Location

Investigator Site 4311

Heidelberg, 69120, Germany

Location

Investigator Site 5401

Bialystok, 15-274, Poland

Location

Investigator Site 5404

Gdansk, 80-952, Poland

Location

Investigator Site 5406

Krakow, 30-663, Poland

Location

Investigator Site 5402

Lodz, 93-338, Poland

Location

Investigator Site 5403

Lublin, 20-093, Poland

Location

Investigator Site 5405

Warsaw, 02-091, Poland

Location

Investigator Site 7906

Dnipro, 49000, Ukraine

Location

Investigator Site 7903

Kharkiv, 61075, Ukraine

Location

Investigator Site 7904

Kyiv, 04050, Ukraine

Location

MeSH Terms

Conditions

Hyperkalemia; Renal Insufficiency, Chronic

Interventions

patiromer; Suspensions

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: EMERALD Clinical Study Team
• Organization: Vifor Pharma, Inc.

EMERALD.study@viforpharma.com

+41 588 518 000

Study Officials

• Julian Platon, MD, PhD

  Vifor Pharma, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2017
• First Posted: March 22, 2017
• Study Start: July 7, 2017
• Primary Completion: January 13, 2021
• Study Completion: April 30, 2021
• Last Updated: October 19, 2022
• Results First Posted: September 26, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

UA (3); US (10); CA (1); BU (1); GE (5); DE (4); PL (6)