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NCT04469907

Study to Assess the Pharmacokinetics and Safety of AZD9977 in Participants With Renal Impairment

Completed Phase 1 Last updated 11 March 2022
What this trial tests

Phase 1 trial testing AZD9977 in Renal Impairment in 18 participants. Completed in 28 October 2021.

Timeline
22 June 2020
Primary endpoint
28 October 2021
28 October 2021

Quick facts

Lead sponsorAstraZeneca
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment18
Start date22 June 2020
Primary completion28 October 2021
Estimated completion28 October 2021
Sites6 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

AstraZeneca — full company profile →

Who can join

Adults 18 to 80, any sex, with Renal Impairment. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a single dose, non-randomized, open-label, parallel group study. The study will be conducted in participants with severe renal impairment and compared with matched participants with normal renal function. The duration of the study for an individual participant from Screening to Follow-up will be approximately 5 weeks.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Mineralocorticoid receptor antagonist use in chronic kidney disease with type 2 diabetes: a clinical practice document by the European Renal Best Practice (ERBP) board of the European Renal Association (ERA).
    Sarafidis P, Iatridi F, Ferro C, Alexandrou ME, et al · · 2023 · cited 26× · PMID 37915899 · DOI 10.1093/ckj/sfad139
  2. The effect of severe renal impairment on the pharmacokinetics, safety and tolerability of balcinrenone.
    Bhattacharya CS, Ericsson H, Johansson S, Parkinson J, et al · · 2025 · cited 3× · PMID 39962632 · DOI 10.1002/bcp.70017
  3. Population Pharmacokinetic Analysis of Balcinrenone in Healthy Participants and Participants with Heart Failure and Chronic Kidney Disease.
    Parkinson J, Åstrand M, Melin J, Ericsson H. · · 2025 · PMID 40965596 · DOI 10.1007/s40262-025-01572-7

Verify or expand the search:

Other trials of AZD9977

Trials testing the same drug.

Other recruiting trials for Renal Impairment

Currently open trials in the same condition.

Other AstraZeneca trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04469907.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing