💬In plain words
What the trial is, and whether it could suit you
This is a phase III, prospective, randomized, double-blind, placebo-controlled, single-center, pilot trial, aimed at assessing whether treatment with the oral potassium binder patiromer as compared to placebo allows withdrawal or down-titration of potassium dietary restriction without increasing the risk of hyperkalemia in chronic dialysis patients.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria (to be eligible to participate in this trial, an individual must meet all the following criteria):
* More than 18-year-old
* Chronic and stable dialysis therapy with three weekly dialysis sessions for at least three months because of ESKD
* Pre-dialysis (in the long interdialytic period) serum potassium 4 to 5.5 mEq/L confirmed in two consecutive weeks, without any clinical signs or symptoms of hyperkalemia
* Stable therapy (since at least 3 months) with RAS inhibitors or MRAs. No treatment with potassium sparing diuretics
* On standardized and stable (moderately or strictly restricted) low-potassium diet
* Compliance with recommended diet
* Written informed consent
Exclusion Criteria (an individual who meets any of the following criteria will be excluded from participation in this trial):
* Hyperkalemia (pre-dialysis potassium \>5.5 mEq/L during the long interdialytic period)
* Hypomagnesemia (serum magnesium \<1.7 mg/dL)
* Hypercalcemia (serum calcium \>10.5mg/dl)
* Ongoing treatment with potassium binding medications including Sodium polystyrene sulfonate (SPS, Kayexalate®, Sanofi-Aventis S.p.A) or Sodium zirconium cyclosilate (Lokelma®, Astra Zeneca S.p.A.)
* Ongoing treatment with potassium-sparing diuretics
* Pre-dialysis potassium \<4.0 mEq/L during the long interdialytic period
* One or two weekly dialysis session
* Poor compliance to prescribed potassium-restricted diet
* History of bowel obstruction or major gastrointestinal surgery, severe gastrointestinal disorders, or swallowing disorders
* Previous history of cardiac arrhythmias potentially related to hypokalemia
* Known hypersensitivity to the active ingredient or any of the excipients of the study drug
* Inability to fully understand the potential risks and benefits related to study participation
* Concomitance of clinical conditions that could jeopardize the completion of the treatment period and/or confound data interpretation including:
* Cancer (except non-metastatic cutaneous cancers)
* Active systemic autoimmune diseases
* Concomitant treatment with steroids or any other immunosuppressive agent
* Severe/unstable heart failure requiring hospitalization or changes in pharmacological therapy or supplementary dialysis sessions over the last three months
* Refractory severe hypertension (BP \>180/100 mmHg despite optimized pharmacological treatment with at least three blood pressure-lowering medications)
* Known to be positive for human immunodeficiency virus
* Drug or alcohol abuse
* Pregnancy, lactation, or intention to become pregnant before or during the study period, or within 90 days of the last dose of study treatment
* Intention to donate ova or sperm over the same period
* Childbearing potential without highly effective contraception methods according to the 2020 CTFG Recommendations related to contraception and pregnancy testing in clinical trials (https://www.hma.eu/fileadmin/dateien/Human\_Medicines/01About\_HMA/Working\_Groups/CTFG/2020\_09\_HMA\_CTFG\_Contraception\_guidance\_Version\_1.1\_updated.pdf)
* Involvement in the study planning and/or conduct
* Participation in another clinical study with an investigational product during the last month