Chronic Kidney Disease and Hyperkalemia MedDRA version: 21.1 Level: LLT Classification code 10020647 Term: Hyperkalemia System Organ Class: 100000004861
Conditions
Interventions
Trade Name: Veltassa®
Product Name: Patiromer
Product Code: RLY5016
Pharmaceutical Form: Powder for oral suspension
INN or Proposed INN: Patiromer for oral suspension
Current Sponsor code: RLY5016S
Sponsors
Vifor Pharma, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Written assent (when applicable) and written informed consent by a legally authorized representative provided prior to participation in the study 2.Age 2 – =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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 peritoneal dialysis, 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 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 hyper or hypoglycemia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess change from baseline in serum potassium levels to Day 14 following administration of different doses of patiromer administered once daily in children 2 – < 18 years of age with chronic kidney disease (CKD) and hyperkalemia.;Secondary Objective: To assess the safety and tolerability of patiromer in children 2 – < 18 years of age with CKD and hyperkalemia.;Primary end point(s): Change in serum potassium levels from baseline to Day 14.;Timepoint(s) of evaluation of this end point: Day 14. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Proportion of subjects with serum potassium levels in the range of 3.8 – 5.0 mEq/L at Day 14 (Initial Pharmacodynamic [PD] / Dose Finding Phase) Proportion of subjects with serum potassium levels in the range of 3.8 – 5.0 mEq/L by visit through Month 6 (Long-Term Treatment Phase) ;Timepoint(s) of evaluation of this end point: Day 14. Month 6. | — |
Countries
Bulgaria, Canada, Georgia, Germany, Poland, South Africa, Ukraine, United States
Contacts
Public ContactEMERALD Clinical Study Team
Vifor Pharma, Inc.
Outcome results
None listed