Patiromer and Diet/hrQoL in Chronic Dialysis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorMario Negri Institute for Pharmacological Research
About this trial
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
Qualifiers
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
Disqualifiers
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.)
Trial design
Treatments tested in this trial
- Patiromer 8400 MG [Veltassa]
- Placebo
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov