Tests patiromer against placebo in adults on chronic dialysis
Tests patiromer, a potassium binder, in adults on chronic dialysis.
Plain-language title generated from the registry record
Registry title: Patiromer and Diet/hrQoL in Chronic Dialysis
Key facts
- Where
- Bergamo, Busto Arsizio, Cinisello Balsamo, Saronno, and Sesto San Giovanni, ItalySee the 5 sites
- Phase
- Phase 3
Where in Italy
- Azienda Socio Sanitaria Territoriale Papa Giovanni XXIIIBergamo, ItalyTaking people
- Azienda Socio Sanitaria Territoriale Della Valle OlonaBusto Arsizio, ItalyTaking people
- Azienda Socio Sanitaria Territoriale Nord MilanoCinisello Balsamo, ItalyTaking people
- Azienda Socio Sanitaria Territoriale Della Valle OlonaSaronno, ItalyTaking people
- Azienda Socio-Sanitaria Territoriale Nord MilanoSesto San Giovanni, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Mario Negri Institute for Pharmacological Research
- Trial code
- NCT06858280EU 2025-521378-33-00
- Record updated
- 4 September 2025
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: Previous history of cardiac arrhythmias potentially related to hypokalemia; Concomitant treatment with steroids or any other immunosuppressive agent; Refractory severe hypertension (BP >180/100 mmHg despite optimized pharmacological treatment with at least three blood pressure-lowering medications); Drug or alcohol abuse; Participation in another clinical study with an investigational product during the last month; History of bowel obstruction or major gastrointestinal surgery, severe gastrointestinal disorders, or swallowing disorders; Known hypersensitivity to the active ingredient or any of the excipients of the study drug; 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; Severe/unstable heart failure requiring hospitalization or changes in pharmacological therapy or supplementary dialysis sessions over the last three months; 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; Poor compliance to prescribed potassium-restricted diet; One or two weekly dialysis session; Inability to fully understand the potential risks and benefits related to study participation; Known to be positive for human immunodeficiency virus; 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.