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NCT04469907
Study to Assess the Pharmacokinetics and Safety of AZD9977 in Participants With Renal Impairment
Phase 1 trial testing AZD9977 in Renal Impairment in 18 participants. Completed in 28 October 2021.
28 October 2021
Quick facts
| Lead sponsor | AstraZeneca |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 18 |
| Start date | 22 June 2020 |
| Primary completion | 28 October 2021 |
| Estimated completion | 28 October 2021 |
| Sites | 6 locations across United States |
Drugs / interventions tested
- AZD9977 — full drug profile →
Conditions studied
- Renal Impairment — all drugs for Renal Impairment →
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):
-
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 -
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 -
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:
- PubMed search for NCT04469907
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of AZD9977
Trials testing the same drug.
- NCT04595370 — Efficacy, Safety and Tolerability of AZD9977 and Dapagliflozin in Participants With Heart Failure and Chronic Kidney Dis · Phase 2 · completed
- NCT03843060 — A Phase 1 Study to Assess the Pharmacokinetics of AZD9977 Administered Alone and in Combination With Itraconazole in Hea · Phase 1 · completed
- NCT03801967 — A Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD9977 in Japanese Healthy Participants With Single · Phase 1 · completed
- NCT03682497 — Study in HFpEF Patients to Compare the Effect of AZD9977 and Spironolactone on Serum Potassium · Phase 1 · terminated
- NCT03435276 — Multiple-ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD9977 in Healthy Male Subject · Phase 1 · completed
Other recruiting trials for Renal Impairment
Currently open trials in the same condition.
- NCT07348237 — A Clinical Trial of MK-2828 in People With Kidney Disease (MK-2828-006) · Phase 1 · recruiting
- NCT07315360 — A Study to Learn How the Body Processes the Study Medicine PF-07328948 in People With Reduced Kidney Function · Phase 1 · recruiting
- NCT07217886 — A Study of S-892216-PO in Participants With Renal Impairment and Matched Controls · Phase 1 · recruiting
- NCT07154901 — Investigation of the Effects of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of Opemalirsen (AZD23 · Phase 1 · recruiting
- NCT07017933 — Groundbreaking Renal Assist Device Intervening to ENhance cardioThoracic Surgery Outcomes · NA · recruiting
Other AstraZeneca trials
Trials by the same sponsor.
- NCT06998095 — Tezepelumab (Tezspire) Regulatory Postmarketing Surveillance in Korea · not yet recruiting
- NCT07431775 — Saphnelo Use in Females of Child-bearing Potential · not yet recruiting
- NCT07516184 — Explore the Diagnostic Value of Bronchodilation Test With Portable Oscillometry in Asthma Diagnosis · NA · not yet recruiting
- NCT07279935 — Osimertinib Combined With Chemotherapy in Patients Who Had Distant Recurrence After Adjuvant Osimertinib for EGFRm Resec · Phase 4 · not yet recruiting
- NCT07279948 — A Single-arm Observational Study to Characterize the Demographic, Clinical Features and Outcomes of a Brazilian Cohort o · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04469907 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by AstraZeneca
- Last refreshed: 11 March 2022
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