Keeping RAASi Treatment With Optimal Potassium Control

Recruiting Phase 3 Interventional Study
Chronic Kidney Diseases
No Placebo Group Every participant receives an active treatment — no one gets a placebo. 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
78 (estimated)
Sponsor
Fundación para la Investigación del Hospital Clínico de Valencia · Other
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About This Trial

Phase III, multicenter, randomized, open-label, parallel-group, non-inferiority, phase III clinical trial comparing CSZ (Lokelma) vs. iSRAA discontinuation/reduction and/or ARM (standard treatment).

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Patients must present serum potassium levels of 5.5-6.5 mEq/L at patient selection visit (V0) * Patients must present serum potassium levels of 5.0-6.5 mEq/L at randomization visit (V1). * Provision of patient or legal representative informed consent prior to any study specifi…
Contacts

Jose Luis Górriz

+34 96 197 38 11

jlgorriz@gmail.com

CONTACT