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
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults on stable long-term dialysis with normal-range blood potassium who follow a low-potassium diet. It tests patiromer against placebo.
- Age
- Older than 18 years.
- Sex
- All sexes can join.
- Disease stage
- End-stage kidney disease on chronic dialysis, three sessions a week for at least three months.
- Earlier treatment
- Stable treatment with RAS inhibitors or MRAs for at least 3 months, and a stable low-potassium diet. No potassium-sparing diuretics.
- Biomarker or test result
- Blood potassium before dialysis (long gap between sessions) of 4 to 5.5 mEq/L on two consecutive weeks, with no signs of high potassium.
Main reasons for not taking part
- High potassium (above 5.5 mEq/L) or low potassium (below 4.0 mEq/L) before dialysis
- Current potassium binder or potassium-sparing diuretic treatment
- Only one or two dialysis sessions a week
- Cancer (except non-metastatic skin cancers), HIV, or drug or alcohol abuse
- Pregnancy or breastfeeding
This trial only enrols participants on dialysis. The registry sentence this rests on: Chronic and stable dialysis therapy with three weekly dialysis sessions for at least three months because of ESKD
Read by machine on 12 November 2026.
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.