NCT06858280 Patiromer and Diet/hrQoL in Chronic Dialysis
| NCT ID | NCT06858280 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Mario Negri Institute for Pharmacological Research |
| Condition | Hyperkalaemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-07-08 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 40 participants in total. It began in 2025-07-08 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06858280 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hyperkalaemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06858280 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 40 participants.
Is NCT06858280 currently recruiting?
Yes, NCT06858280 is actively recruiting participants. Contact the research team at pruggenenti@asst-pg23.it for enrollment information.
Where is the NCT06858280 trial being conducted?
This trial is being conducted at Bergamo, Italy.
Who is sponsoring the NCT06858280 clinical trial?
NCT06858280 is sponsored by Mario Negri Institute for Pharmacological Research. The trial plans to enroll 40 participants.