Study of the Effect of Haemodialysis on the Pharmacokinetics, Safety, and Tolerability of Balcinrenone/Dapagliflozin

StatusCompleted
PhasePhase 1
Started

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Record History

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  1. Primary endpoints: details revised at 3 of 14 entries Show 6 more changesShow less
    • Trial completed
    • Primary completion date changed from estimate of Dec 3, 2026 to Oct 6, 2026
    • Interventions: Balcinrenone/dapagliflozin (Drug) to Balcinrenone/dapagliflozin (Drug)
    • Eligibility criteria expanded, about 23 words
    • Secondary endpoints: details revised at 2 of 2 entries
    • Site details revised
  2. Recruitment opened
    • Primary and study completion dates: Dec 2, 2026 to Dec 3, 2026
    • Start date changed from estimate of Aug 5, 2026 to Aug 6, 2026
    • Site details revised
    v2
  3. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
AstraZeneca
732 trials monitored
See 61 trials at risk
The purpose of this study is to investigate the effect of HD on single oral dose PK, safety, and tolerability of balcinrenone/dapagliflozin to male and female participants with kidney failure on intermittent HD.
Trial Details
NCT Number NCT07754331
Lead Sponsor AstraZeneca
Collaborators: Fortrea
Conditions
(from sponsor)		 Kidney Failure
Related terms Renal Insufficiency
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov