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Patiromer and Diet/hrQoL in Chronic Dialysis

NCT06858280 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-09-04

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Patiromer 8400 MG [Veltassa]

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.

DRUG

Placebo

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.

Sponsors & Collaborators

  • Mario Negri Institute for Pharmacological Research

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-08
Primary Completion
2026-07-31
Completion
2026-07-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06858280 on ClinicalTrials.gov