Patiromer and Diet/hrQoL in Chronic Dialysis

Sponsor
Mario Negri Institute for Pharmacological Research
Study ID
NCT06858280
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Chronic Kidney Disease Stage 3 and 4
  • Dietary Intervention
  • Hyperkalaemia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Patiromer 8400 MG [Veltassa] — DRUG
    Randomized 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 — DRUG
    Randomized 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.

Study Details

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.

Key Dates

Start date
Jul 8, 2025
Status verified
Aug 2025
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Patiromer
    Participants will be stratified according to the number of weekly dialysis sessions (2 vs 3) and within each stratum, and will be randomized on 1:1 basis to 3-month treatment with patiromer.
  • Placebo Comparator: Placebo
    Participants will be stratified according to the number of weekly dialysis sessions (2 vs 3) and within each stratum, and will be randomized on 1:1 basis to 3-month treatment with the placebo.

Primary Outcome Measure

Serum potassium levels [ Time Frame: Before every dialysis session for 12 weeks after recruitment ]

Central Contacts

Related Studies