Patiromer for Pediatric Hyperkalemia
Recruiting in Palo Alto (17 mi)
+10 other locations
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Vifor Pharma, Inc.
Must not be taking: Digoxin, Bronchodilators, Theophylline, others
Disqualifiers: Preterm birth, Renal conditions, Severe GI issues, others
No Placebo Group
Prior Safety Data
Approved in 2 jurisdictions
Trial Summary
What is the purpose of this trial?A study to evaluate the pharmacodynamic effects, safety, and tolerability of patiromer in children under 12 years of age with hyperkalaemia
Will I have to stop taking my current medications?
The trial requires that if you are taking certain medications like RAAS inhibitors, beta blockers, fludrocortisone, or diuretics, you must be on a stable dose for at least 14 days before starting the trial. If you are taking other medications like digoxin or bronchodilators, those doses also need to be stable for 14 days before the trial and should not change during the trial.
Is patiromer safe for humans?
Patiromer has been generally well tolerated in clinical trials for adults with hyperkalemia, with no serious treatment-related adverse events or deaths reported. Common side effects include mild to moderate constipation and low magnesium levels, with a low risk of low potassium levels.
12345How does the drug patiromer differ from other treatments for hyperkalemia?
Patiromer is unique because it is a sodium-free potassium binder that works by exchanging calcium for potassium in the gut, which helps to lower potassium levels in the blood. Unlike other treatments, it allows patients to continue using certain blood pressure medications (RAAS inhibitors) that can increase potassium levels, making it a valuable option for long-term management of hyperkalemia.
12456Eligibility Criteria
This trial is for children under 6 with hyperkalemia, a condition of high potassium levels in the blood. They must be on stable doses of certain medications if used and able to take food and medicine regularly, including through feeding tubes. Infants born preterm or those with severe kidney issues, hypersensitivity to patiromer, active cancer, significant GI conditions affecting drug transit, or recent investigational drug use are excluded.Inclusion Criteria
Parent(s) or legally authorised representative(s) or another appropriate person delegated by the legally authorised representatives must be available to help the study-site personnel ensure follow-up; accompany the participant to the study site on each assessment day; accurately and reliably dispense investigational product as directed
I am under 12 years old and will not turn 12 during the first 28 days of the trial.
My child is under 12 and has high potassium levels.
+4 more
Exclusion Criteria
My baby was not born before 37 weeks of pregnancy.
Use of any investigational product for an unapproved indication within 30 days prior to screening or within 5 half-lives, whichever is longer
I have kidney issues like dialysis, narrowed arteries, recent injury, or past insufficiency but not chronic disease.
+7 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive patiromer for a 4-week pharmacodynamic/dose-ranging period
4 weeks
Visits on Day 3, Day 7, Day 14, and Day 28
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Long-term follow-up
Participants are monitored for long-term safety and effectiveness
Up to 52 weeks
Participant Groups
The study tests the effects and safety of patiromer in treating hyperkalemia in young children. It aims to understand how well the drug works (pharmacodynamics), its tolerability, and any side effects it may cause during treatment.
1Treatment groups
Experimental Treatment
Group I: PatiromerExperimental Treatment1 Intervention
4-week pharmacodynamic (PD)/dose-ranging period
Cohort 1: 6 to \<12 years of age
Cohort 2: 2 to \<6 years of age
Cohort 3: 0 to \<2 years of age); In Cohort 3, a minimum of 3 study participants will be assessed in the sub-group of 0 to \<6 months and another 3 study participants in the sub-group 6 to \<24 months of age.
Patiromer is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Veltassa for:
- Hyperkalemia in adults and geriatric patients
🇪🇺 Approved in European Union as Veltassa for:
- Hyperkalemia
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
UF Health Pediatric Multispecialty CenterJacksonville, FL
Children's Mercy Hospitals and ClinicsKansas City, MO
Duke University Hospital & Medical CenterDurham, NC
Miller School of Medicine, University of MiamiMiami, FL
More Trial Locations
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Who Is Running the Clinical Trial?
Vifor Pharma, Inc.Lead Sponsor
References
Cost-Effectiveness of Treating Patients with Chronic Kidney Disease and Prior Hyperkalemia with Renin-Angiotensin-Aldosterone System Inhibitor and Patiromer: A Swiss Public Healthcare Perspective. [2022]Label="INTRODUCTION">Hyperkalemia is associated with increased morbidity and mortality in patients with chronic kidney disease (CKD). Patiromer (Veltassa®) is an oral potassium binder indicated for the treatment of hyperkalemia in adults. We evaluated the impact of patiromer on the Swiss healthcare resources when used in patients with CKD and hyperkalemia who were on renin-angiotensin-aldosterone system inhibitor (RAASi) treatment.
Patiromer: A Review in Hyperkalaemia. [2018]Patiromer (Veltassa(™)) for oral suspension is a sodium-free potassium binder that is approved in the USA for the treatment of hyperkalaemia. In clinical trials, patiromer significantly reduced serum potassium levels from baseline to week 4 in patients with chronic kidney disease (CKD) and mild to severe hyperkalaemia (OPAL-HK), or CKD, mild to moderate hyperkalaemia and type 2 diabetes mellitus (AMETHYST-DN), who were receiving renin-angiotensin-aldosterone system inhibitors (RAASis; drugs that inhibit the renal excretion of potassium). Among patients in OPAL-HK who had moderate to severe hyperkalaemia at baseline and normokalaemia on patiromer and RAASis at week 4, continuing patiromer for a further 8 weeks maintained reductions in potassium levels more effectively than switching to placebo (i.e. withdrawing patiromer); consequently, fewer patiromer than placebo recipients experienced recurrent hyperkalaemia during this period. Furthermore, almost all patiromer (vs. less than half of placebo) recipients were still receiving RAASi therapy at the end of this trial. In AMETHYST-DN, the significant reduction from baseline in serum potassium levels seen at week 4 was sustained for up to 52 weeks. Patiromer was generally well tolerated in these trials, with no treatment-related serious adverse events or deaths. Commonly occurring treatment-related adverse events include mild to moderate constipation and hypomagnesaemia, and there is a low risk of hypokalaemia. In conclusion, oral patiromer is a useful new option for patients with hyperkalaemia.
▼Patiromer for the management of hyperkalaemia. [2018]Hyperkalaemia is a potentially life-threatening condition, in which there is an abnormally high concentration of potassium ions in the blood.1,2 Cation-exchange resins (e.g. calcium or sodium polystyrene sulfonate) that bind potassium in the gastrointestinal tract to increase faecal elimination have been used as part of the management of hyperkalaemia but they have some serious adverse effects, including potentially fatal gastrointestinal necrosis.3,4 Patiromer (▼Veltassa - Vifor Fresenius) is a cation-exchange polymer that is licensed for the treatment of hyperkalaemia in adults and, unlike other exchange resins, its licence is not restricted to people with anuria, severe oliguria or those requiring or undergoing dialysis.5,6 Here, we review the evidence for the efficacy and safety of patiromer and consider its place in the management of hyperkalaemia.
Patiromer: a significant advance in the management of hyperkalemia. [2017]The U.S. Food and Drug Administration (FDA) approved patiromer to treat hyperkalemia on October 21, 2015, making it the first agent approved for this condition in 50 years. Patiromer was developed by Relypsa, Inc. The active ingredient is patiromer sorbitex calcium which consists of the active moiety, patiromer, a nonabsorbed potassium-binding polymer, and a calcium-sorbitol counterion. In the colon, patiromer exchanges calcium for potassium thus causing a fall in serum potassium. Trials have shown that patiromer reduces serum potassium in patients with mild, moderate and moderate to severe hyperkalemia to the normal range. It has also been used successfully in patients with chronic kidney disease and/or heart failure. It has also allowed the use of the mineralocorticoid antagonist spironolactone in full dosage in patients with chronic kidney disease and/or heart failure who were already receiving a renin-angiotensin-aldosterone system inhibitor. Adverse effects have mostly been gastrointestinal in nature and have not caused patients to discontinue treatment in unacceptable numbers.
Treatment of infant formula with patiromer dose dependently decreases potassium concentration. [2020]Hyperkalemia is a potentially life-threatening complication of chronic kidney disease (CKD). Dietary potassium restriction is challenging in infants despite low-potassium formulas. Decreasing potassium in formula using patiromer, a new calcium-based cation exchange polymer may be one option to accomplish this; however, data confirming efficacy is lacking.
Patiromer: A Review in Hyperkalaemia. [2022]Patiromer (Veltassa®) for oral suspension is a non-absorbed, sodium-free potassium binding polymer that exchanges calcium for potassium in the gastrointestinal (GI) tract, thereby increasing faecal potassium excretion and reducing serum potassium levels. Patiromer was approved in the USA in 2015 and is now approved in several other countries, including those of the EU, for the treatment of hyperkalaemia in adults. In clinical trials, patiromer reduced serum potassium levels and the risk of recurrent hyperkalaemia in patients with chronic kidney disease (CKD) and/or diabetic nephropathy with or without heart failure (HF), allowing the majority of patients to continue receiving renin-angiotensin-aldosterone system (RAAS) inhibitors (drugs that inhibit the renal excretion of potassium) for up to 52 weeks. Patiromer also maintained normokalaemia in patients with HF and a propensity for hyperkalaemia, enabling concomitant administration and up-titration of spironolactone. Patiromer was generally well tolerated, with a low risk of hypokalaemia. GI disorders and hypomagnesaemia were the most common adverse events; these were generally of mild or moderate severity. Therefore, oral patiromer is a valuable treatment option for the long-term management of hyperkalaemia.