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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Patiromer 8400 MG [Veltassa]
DrugRandomized patients will receive one 8.4 g packet of patiromer per day or one identical packet containing a placebo. To minimize the possibility of interference with gastrointestinal absorption of other orally administered medications, administration of patiromer will be separated by at least 3 hours from other oral medicinal products. Throughout the whole study period, the study drug will be administered every day in the morning.
Placebo
DrugRandomized patients will receive one packet of placebo identical to that of patiromer. Following the same treatment sequence of patiromer, administration of the placebo will be separated by at least 3 hours from any other oral medicinal products. As for patiromer, the placebo will be administered every day in the morning.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: PatiromerExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Serum potassium levels
Change in serum potassium levels of 0.5mEq/L compared to baseline
Time frame
Before every dialysis session for 12 weeks after recruitmentSponsors and contacts
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Source ClinicalTrials.gov