Patiromer and Diet/hrQoL in Chronic Dialysis (NCT06858280) | Clinical Trial Compass
RecruitingPhase 3
Patiromer and Diet/hrQoL in Chronic Dialysis
Italy40 participantsStarted 2025-07-08
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 gas…
What they're measuring
1
Serum potassium levels
Timeframe: Before every dialysis session for 12 weeks after recruitment
Trial details
NCT IDNCT06858280
SponsorMario Negri Institute for Pharmacological Research