NCT04865393 is a Phase 1 clinical trial of SPR206 in Renal Impairment, sponsored by Spero Therapeutics.

Who is sponsoring NCT04865393?

NCT04865393 is sponsored by Spero Therapeutics.

What drugs are being tested in NCT04865393?

Interventions in NCT04865393: SPR206.

What condition does NCT04865393 study?

NCT04865393 studies Renal Impairment.

Is NCT04865393 still recruiting?

NCT04865393 is currently completed. Last updated 15 April 2024.

Last reviewed 2024-04-15 · How we verify

NCT04865393

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

Phase 1 Study of PK and Safety of SPR206 in Subjects With Various Degrees Of Renal Function

Completed Phase 1 Last updated 15 April 2024

What this trial tests

Phase 1 trial testing SPR206 in Renal Impairment in 37 participants. Completed in 6 December 2021.

Timeline

8 June 2021

Primary endpoint
1 December 2021

6 December 2021

Quick facts

Lead sponsor	Spero Therapeutics
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	37
Start date	8 June 2021
Primary completion	1 December 2021
Estimated completion	6 December 2021
Sites	2 locations across New Zealand

Drugs / interventions tested

SPR206 — full drug profile →

Conditions studied

Renal Impairment — all drugs for Renal Impairment →

Sponsor

Spero Therapeutics — full company profile →

Who can join

18 and older, any sex, with Renal Impairment. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Evaluation of the pharmacokinetics (PK) of SPR206 in subjects with normal renal function, subjects with various degrees of renal insufficiency, and subjects with end-stage renal disease (ESRD) receiving hemodialysis (HD) therapy.

Publications & conference data

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

ESKAPE pathogens: antimicrobial resistance, epidemiology, clinical impact and therapeutics.
Miller WR, Arias CA. · · 2024 · cited 481× · PMID 38831030 · DOI 10.1038/s41579-024-01054-w
Antibiotics in the clinical pipeline as of December 2022.
Butler MS, Henderson IR, Capon RJ, Blaskovich MAT. · · 2023 · cited 147× · PMID 37291465 · DOI 10.1038/s41429-023-00629-8
Next-Generation Polymyxin Class of Antibiotics: A Ray of Hope Illuminating a Dark Road.
Aslan AT, Akova M, Paterson DL. · · 2022 · cited 23× · PMID 36551367 · DOI 10.3390/antibiotics11121711
Novel drug candidates against antibiotic-resistant microorganisms: A review.
Lim JS, Chai YY, Ser WX, Haeren AV, et al · · 2024 · cited 14× · PMID 38234674 · DOI 10.22038/ijbms.2023.71672.15593
Antibacterials with Novel Chemical Scaffolds in Clinical Development.
Heimann D, Kohnhäuser D, Kohnhäuser AJ, Brönstrup M. · · 2025 · cited 10× · PMID 39847315 · DOI 10.1007/s40265-024-02137-x
Safety and pharmacokinetics of SPR206 in subjects with varying degrees of renal impairment.
Bruss JB, Bader J, Hamed KA. · · 2023 · cited 8× · PMID 37823647 · DOI 10.1128/aac.00505-23

Verify or expand the search:

Other trials of SPR206

Trials testing the same drug.

NCT04868292 — Study to Assess the Intrapulmonary Pharmacokinetics of SPR206 in Healthy Volunteers · Phase 1 · completed
NCT03792308 — A First in Human Study of the Safety and Tolerability of Single and Multiple Doses of SPR206 in Healthy Volunteers · 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 Spero Therapeutics trials

Trials by the same sponsor.

NCT06727136 — A Study to Characterize Single and Repeat Dose Pharmacokinetics of Tebipenem-Pivoxil-Hydrobromide (TBP-PI-HBr) and Its M · Phase 1 · completed
NCT06059846 — A Study of Oral Tebipenem Pivoxil Hydrobromide (TBP-PI-HBr) Compared to Intravenous Imipenem-cilastatin in Participants · Phase 3 · completed
NCT05966688 — A Study to Evaluate the Effect of Co-administration on the Pharmacokinetics of SPR720, Azithromycin, and Ethambutol in H · Phase 1 · completed
NCT05955586 — A Study to Assess the Intrapulmonary Pharmacokinetics (PK) of SPR719 by Comparing the Plasma, Epithelial Lining Fluid, a · Phase 1 · completed
NCT05856747 — A Study to Compare Two Bioanalytical Assays for Tebipenem · Phase 1 · completed

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 NCT04865393 (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 Spero Therapeutics
Last refreshed: 15 April 2024

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/NCT04865393.

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