NCT04949438 is a Phase 1 clinical trial of AZD4831 in Renal Impairment, sponsored by AstraZeneca.

Who is sponsoring NCT04949438?

NCT04949438 is sponsored by AstraZeneca.

What drugs are being tested in NCT04949438?

Interventions in NCT04949438: AZD4831.

What condition does NCT04949438 study?

NCT04949438 studies Renal Impairment.

Is NCT04949438 still recruiting?

NCT04949438 is currently completed. Last updated 5 April 2022.

Last reviewed 2022-04-05 · How we verify

NCT04949438

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study to Assess the Pharmacokinetics (Uptake of Drugs by the Body), Safety and Tolerability of AZD4831 in Participants With Severe Renal Impairment and Healthy Volunteers

Completed Phase 1 Last updated 5 April 2022

What this trial tests

Phase 1 trial testing AZD4831 in Renal Impairment in 20 participants. Completed in 4 March 2022.

Timeline

21 January 2022

Primary endpoint
4 March 2022

4 March 2022

Quick facts

Lead sponsor	AstraZeneca
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	21 January 2022
Primary completion	4 March 2022
Estimated completion	4 March 2022
Sites	1 location across Bulgaria

Drugs / interventions tested

AZD4831 — 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 study to compare AZD4831 pharmacokinetic (PK) parameters between participants with severe renal impairment and matched healthy volunteers following a single dose administration.

Publications & conference data

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

The effect of severe renal impairment on the pharmacokinetics, safety and tolerability of mitiperstat.
Bhattacharya CS, Pizzato PE, Heijer M, Sunnåker M, et al · · 2024 · cited 2× · PMID 39134325 · DOI 10.1111/bcp.16205
Population Pharmacokinetics of the Novel Myeloperoxidase Inhibitor Mitiperstat.
Sunnåker M, Leander J, Ericsson H. · · 2026 · PMID 42101107 · DOI 10.1002/prp2.70259

Verify or expand the search:

Other trials of AZD4831

Trials testing the same drug.

NCT05638737 — A Study in Participants With Non-cirrhotic NASH With Fibrosis · Phase 2 · completed
NCT05457270 — A Study to Assess the Relative Bioavailability and Safety of Different Formulations of AZD4831 in Fasted State in Health · Phase 1 · completed
NCT05236543 — A Study to Assess the Pharmacokinetics of AZD4831 When Administered Alone and in Combination With Itraconazole · Phase 1 · completed
NCT05052710 — Study to Assess the Effect of AZD4831 on the Pharmacokinetics (Drug Behavior in the Body) of Midazolam · Phase 1 · completed
NCT04986202 — Study to Evaluate the Efficacy and Safety of AZD4831 in Participants With Heart Failure With Left Ventricular Ejection F · Phase 2, PHASE3 · 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)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04949438 (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: 5 April 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/NCT04949438.

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