Trial intelligence / Profile preview

Patiromer for RAAS Inhibitor Maintenance in CKD (DROP)

NCT05786469Phase 3

Key facts

Status: Terminated
Start: Aug 2023
Primary completion: Nov 2024
Countries: 1
Sponsor: Mario Negri Institute for Pharmacological Research
Modality: Polymer-based Nanoparticles, Small Molecules

Drugs: patiromer
Conditions: hyperkalemia

Overview

Phase 3, randomised, double-blind trial in hyperkalemia comparing Patiromer with Placebo (2 arms). Primary endpoint: Rate of withdrawal or down-titration of RAAS inhibition therapy because of refractory hyperkalemia at 6 months. Started Aug 2023; status: terminated.

Design

2 arms

Study design: RandomizedDouble-blind

Patiromer
Patiromer 8.4 g/day
Placebo
Placebo

Who it enrols

Adult patients with CKD (eGFR <45) and hyperkalemia (K+ >= 5.0) on RAAS inhibitors. Excludes patients on SPS, with rapid kidney progression, active autoimmune disease, or severe heart failure.

Endpoints

Primary

Rate of withdrawal or down-titration of RAAS inhibition therapy because of refractory hyperkalemia6 months

Secondary

Changes in serum potassium normalization6 months
Changes in metabolic laboratory parameters6 months
Changes in renal function parameters6 months
Change in clinical parameters6 months
Events6 months
Costs6 months
Questionnaire replies6 months
Safety6 months

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