Patiromer to allow more flexible potassium diets and improve quality of life for people on chronic dialysis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, randomized, double-blind, placebo-controlled, single-center Phase 3 pilot trial comparing oral patiromer 8,400 mg to placebo in patients on chronic thrice-weekly hemodialysis. Eligible participants are adults dialyzing for at least three months with stable pre-dialysis potassium between 4.0 and 5.5 mEq/L and on a standardized low-potassium diet and stable RAS inhibitor or MRA therapy. The intervention aims to permit down-titration or withdrawal of dietary potassium restrictions while monitoring pre-dialysis potassium and safety labs to detect hyperkalemia or electrolyte disturbances. Outcomes include change in ability to liberalize diet without increasing clinically significant hyperkalemia and measures of diet-related quality of life.

Why it matters

Who can join: the full rules

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

Where it's running

• Nephrology Unit, ASST Papa Giovanni XXIII
  Bergamo, Bg, Italy Recruiting

Study contacts

• Study coordinator: Piero L Ruggenenti, M.D.
• Email: pruggenenti@asst-pg23.it
• Phone: +390352673814

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.