Patiromer and Diet/hrQoL in Chronic Dialysis
Impact of Patiromer Treatment on Dietary Potassium Intake Restriction and Health-related Quality of Life and Nutrition in Patients on Chronic Dialysis Therapy: a Double-Blind, Prospective, Randomized, Placebo-Controlled, Pilot Trial
Mario Negri Institute for Pharmacological Research
40 participants
Jul 8, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria7
- 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 Criteria25
- 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
Interventions
Randomized patients will receive one 8.4 g packet of patiromer per day or one identical packet containing a placebo. To minimize the possibility of interference with gastrointestinal absorption of other orally administered medications, administration of patiromer will be separated by at least 3 hours from other oral medicinal products. Throughout the whole study period, the study drug will be administered every day in the morning.
Randomized patients will receive one packet of placebo identical to that of patiromer. Following the same treatment sequence of patiromer, administration of the placebo will be separated by at least 3 hours from any other oral medicinal products. As for patiromer, the placebo will be administered every day in the morning.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06858280