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.
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