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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
EU CTIS ID: 2025-521378-33-00
What this study is testing
To assess whether treatment with the oral potassium binder patiromer as compared to placebo allows withdrawal or down-titration of potassium dietary restriction considered as a dichotomous variable (YES/NO) without increasing the risk of hyperkalemia (serum potassium >5.5 mEq/L) in chronic dialysis patients with pre-dialysis serum potassium 4 to 5.5 mEq/L ) achieved and maintained by dietary restriction of potassium reach aliments
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Hyperkalemia (pre-dialysis potassium >5.5 mEq/L during the long interdialytic period)
- 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
See the full eligibility 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
- Hyperkalemia (pre-dialysis potassium >5.5 mEq/L during the long interdialytic period)
- 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.