A Clinical Trial to Evaluate the Effectivenes, Safety, and Tolerability of Patiromer for Oral Administration in Children and Adolescents aged 2 to < 18 Years with Chronic Kidney Disease and High Levels of Serum Potassium Concentratio
- Conditions
- Chronic Kidney Disease and HyperkalemiaMedDRA version: 20.1Level: LLTClassification code 10020647Term: HyperkalemiaSystem Organ Class: 100000004861Therapeutic area: Not possible to specify
- Registration Number
- EUCTR2016-002785-31-PL
- Lead Sponsor
- Relypsa, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 54
1.Written assent (when applicable) and written informed consent by a legally authorized representative provided prior to participation in the study
2.Age 2 – < 18 years old (subject’s age should not exceed that of the age cohort into which s/he is enrolled for at least the entire 14 days of the PD / Dose Finding Phase)
3.Pediatric subjects with CKD and eGFR < 60 mL/min/1.73m2 calculated using the Schwartz formula, including renal transplant and peritoneal dialysis subjects, based on local creatinine measurement at Screening
4.Two blood or serum potassium measurements of 5.1 to < 6.5 mEq/L performed on separate days
5.In the opinion of the Investigator, the subject is expected to require treatment for hyperkalemia for at least 6 months
6.If taking any renin-angiotensin aldosterone system inhibitors (RAASi), beta blockers, fludrocortisone or diuretic medications, must be on a stable dose for at least 28 days prior to Screening
7.Females of child-bearing potential must be non-lactating, must have a negative pregnancy test at Screening, and must have used an effective form of contraception (e.g. abstinence, hormonal, chemical, physical barrier, etc.) for at least 1 month before patiromer administration. Subjects of child-bearing potential must agree to continue using contraception throughout the study and for 1 month after the last dose of patiromer
Are the trial subjects under 18? yes
Number of subjects for this age range: 54
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1.Subjects with 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
2.Any subject with evidence of potential potassium-related ECG changes (i.e., changes consistent with hyper- or hypokalemia) at Screening
3.Any of the following renal conditions: maintenance hemodialysis or planned need for hemodialysis during the study, renal artery stenosis, and acute kidney injury (defined by 2012 Kidney Disease Improving Global Outcomes [KDIGO], 2012) or a history of acute renal insufficiency in the past 3 months
4.A history of or current diagnosis of a severe gastrointestinal diagnosis or surgery that could affect gastrointestinal transit of the drug (e.g. a severe swallowing disorder, 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)
5.A history of or current diagnosis of a condition that in the opinion of the investigator increases the risk of aspiration of patiromer if it will be given orally
6.Liver enzymes [alanine aminotransferase (ALT), aspartate aminotransferase (AST) > three times upper limit of normal at Screening, based on the local laboratory ALT and AST
7.Active cancer, currently on cancer treatment or history of cancer in the past 2 years (except for non-melanoma skin cancer)
8.Heart or liver transplant recipient, 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)
9.Chronic alcohol abuse or substance use disorder within 1 year of Screening
10.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, sodium zirconium cyclosilicate and drospirenone.
11.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 14-day PD / Dose Finding Phase:
-digoxin;
-bronchodilators;
-theophylline;
-heparins (including low molecular heparins);
-canagliflozin;
-tacrolimus;
-mycophenolate mofetil;
-cyclosporine
-trimethoprim or cotrimoxazole
12.Use of any investigational product for an unapproved indication within 30 days prior to Screening or within 5 half-lives, whichever is longer
13.Known hypersensitivity to patiromer or its components
14.In the opinion of the Investigator, inability to comply with the protocol
15.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 such as: hyperkalemia at Screening that requires emergency intervention; cardiovascular event or intervention within 3 months prior to Screening; a hemodynamically unstable arrhythmia; hospitalization for heart failure (HF) within the past 3 months; poorly controlled blood pressure (BP); poorly controlled diabetes mellitus or frequent need for adjustment in insulin prescription or recent hospitalization for treatment of
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method