PATIROMER for End-stage renal disease (chronic dialysis)

Inclusion criteria

• {"criterion_text":"- More than 18-year-old\n- Chronic and stable dialysis therapy with three weekly dialysis sessions for at least three months because of ESKD\n- 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\n- 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\n- Compliance with recommended diet\n- Written informed consent"}

Exclusion criteria

• {"criterion_text":"- Hyperkalemia (pre-dialysis potassium >5.5 mEq/L during the long interdialytic period)\n- Previous history of cardiac arrhythmias potentially related to hypokalemia\n- Known hypersensitivity to the active ingredient or any of the excipients of the study drug\n- Inability to fully understand the potential risks and benefits related to study participation\n- Concomitance of clinical conditions that could jeopardize the completion of the treatment period and/or confound data interpretation including: •\tCancer (except non-metastatic cutaneous cancers) •\tActive systemic autoimmune diseases •\tConcomitant treatment with steroids or any other immunosuppressive agent •\tSevere/unstable heart failure requiring hospitalization or changes in pharmacological therapy or supplementary dialysis sessions over the last three months •\tRefractory severe hypertension (BP >180/100 mmHg despite optimized pharmacological treatment with at least three blood pressure-lowering medications) •\tKnown to be positive for human immunodeficiency virus •\tDrug or alcohol abuse\n- Pregnancy, lactation, or intention to become pregnant before or during the study period, or within 90 days of the last dose of study treatment\n- Intention to donate ova or sperm over the same period\n- 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)\n- Involvement in the study planning and/or conduct\n- Participation in another clinical study with an investigational product during the last month\n- Hypomagnesemia (serum magnesium <1.7 mg/dL)\n- Hypercalcemia (serum calcium >10.5mg/dl)\n- 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.)\n- Ongoing treatment with potassium-sparing diuretics\n- Pre-dialysis potassium <4.0 mEq/L during the long interdialytic period\n- One or two weekly dialysis session\n- Poor compliance to prescribed potassium-restricted diet\n- History of bowel obstruction or major gastrointestinal surgery, severe gastrointestinal disorders, or swallowing disorders"}

Primary endpoints

• {"endpoint_text":"- Proportion of participants with low-potassium diet withdrawal and/or down-titration at completion of the treatment period compared to diet at inclusion","definition_or_measurement_approach":"Measured as the proportion (dichotomous variable YES/NO) of participants achieving withdrawal and/or down-titration of low-potassium diet at end of treatment versus inclusion. Safety assessed by monitoring hyperkalemia (serum potassium >5.5 mEq/L)."}

Secondary endpoints

• {"endpoint_text":"- Proportion of participants with low potassium diet withdrawal at completion of the treatment period, considered as a single endpoint","definition_or_measurement_approach":"Proportion (dichotomous) of participants with diet withdrawal at end of treatment."}
• {"endpoint_text":"- Reduction in dietary restriction considered as a continuous variable as assessed by a dietary score (to be defined): 0 = No restriction; 1 = Moderate restriction; 2 = Strict restriction","definition_or_measurement_approach":"Change in dietary restriction measured as a continuous variable using a dietary score with predefined categories 0/1/2."}
• {"endpoint_text":"- Changes in pre-dialysis serum potassium level considered as a continuous variable","definition_or_measurement_approach":"Change in pre-dialysis serum potassium (continuous measure)."}
• {"endpoint_text":"- Reduced need for rescue therapy with potassium binding resins such as Sodium polystyrene sulfonate (SPS, Kayexalate®, Sanofi-Aventis S.p.A) or supplementary dialysis sessions to treat intercurrent hyperkalemia","definition_or_measurement_approach":"Incidence/requirement for rescue therapy (use of SPS or supplementary dialysis sessions) during study period."}
• {"endpoint_text":"- Introduction or optimization of RAS inhibitor therapy to control arterial blood pressure or heart failure and/or prevent cardiovascular events without increasing the risk of hyperkalemia","definition_or_measurement_approach":"Proportion or occurrence of RAS inhibitor introduction/optimization while monitoring for hyperkalemia risk."}
• {"endpoint_text":"- Proportion of patients with cardiac arrhythmias or other symptoms (muscle weakness, fatigue, hand of feet numbness or tingling, vomiting, flaccid paralysis and others) potentially related to hyperkalemia","definition_or_measurement_approach":"Incidence of cardiac arrhythmias or specified symptoms potentially related to hyperkalemia."}
• {"endpoint_text":"- Proportion of patients with hypokalemia (serum potassium <3.5 mEq/L) and/or of cardiac arrhythmias potentially related to hypokalemia","definition_or_measurement_approach":"Incidence of hypokalemia (serum potassium <3.5 mEq/L) and related cardiac arrhythmias."}
• {"endpoint_text":"- Participant’s quality of life change from baseline at the end of the intervention, measured using the Italian translation of the Kidney Disease Quality of Life Instrument (KDQOL) Version 1.31 and the standard SF-36 quality of life questionnaire Italian Version 1.6","definition_or_measurement_approach":"Change from baseline in KDQOL v1.31 (Italian) and SF-36 v1.6 (Italian) scores at end of intervention."}

Italy

Earliest CTIS Part Ii Submission Date

17-06-2025

Latest Decision Or Authorization Date

08-05-2026

Processing Time Days

325

Number Of Sites

5

Number Of Participants

40

Primary sponsor

Full Name

Istituto Di Ricerche Farmacologiche Mario Negri

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Italy