Patiromer and Diet/hrQoL in Chronic Dialysis

Recruiting Phase 3 Interventional Study
Hyperkalaemia Chronic Kidney Disease Stage 3 and 4 Dietary Intervention
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
40 (estimated)
Sponsor
Mario Negri Institute for Pharmacological Research · Other
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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.

Trial Locations
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Eligibility Criteria
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…
Contacts

Piero L Ruggenenti, M.D.

+390352673814

pruggenenti@asst-pg23.it

CONTACT