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NCT04142970
Safety and Pharmacokinetics/Pharmacodynamics of HSK3486 in Patients With Impairment Renal Functions
Phase 1 trial testing HSK3486 in Chronic Renal Impairment in 24 participants. Completed in 18 August 2020.
4 August 2020
Quick facts
| Lead sponsor | Sichuan Haisco Pharmaceutical Group Co., Ltd |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | other |
| Enrollment | 24 |
| Start date | 5 January 2020 |
| Primary completion | 4 August 2020 |
| Estimated completion | 18 August 2020 |
| Sites | 1 location across China |
Drugs / interventions tested
- HSK3486 — full drug profile →
Conditions studied
- Chronic Renal Impairment — all drugs for Chronic Renal Impairment →
Sponsor
Sichuan Haisco Pharmaceutical Group Co., Ltd — full company profile →
Who can join
Adults 18 to 64, any sex, with Chronic Renal Impairment. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A Clinical Study Comparatively Evaluating the Pharmacokinetics, Pharmacodynamics and Safety of Intravenous Administration of HSK3486 Injectable Emulsion in Patients with Chronic Renal Impairment and Subjects with Normal Renal Functions
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Pharmacokinetics, pharmacodynamics, and safety of ciprofol emulsion in Chinese subjects with normal or impaired renal function.
Tao J, Liu S, Zhao YY, Qi L, et al · · 2023 · cited 14× · PMID 38074142 · DOI 10.3389/fphar.2023.1260599 -
Pharmacokinetics, Pharmacodynamics, and Safety of Ciprofol Injectable in Chinese Subjects with Normal or Impaired Renal Function
Tao J, Liu S, Zhao Y, Qi L, et al · · 2023 · DOI 10.21203/rs.3.rs-2712144/v1
Verify or expand the search:
- PubMed search for NCT04142970
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of HSK3486
Trials testing the same drug.
- NCT06795204 — Effects of HSK3486 on Cardiac Repolarization in Health Subjects (TQT) · Phase 1 · completed
- NCT05486416 — Safety and Efficacy of HSK3486 Compared to Propofol for Induction of General Anesthesia in Adults With Elective Surgery · Phase 3 · completed
- NCT05614544 — Dose-Finding and Human Abuse Potential Study Of HSK3486 Injection In Nondependent, Recreational Central Nervous System D · Phase 1 · completed
- NCT07404306 — Part 1: Dose-Finding of HSK3486 Injection In Nondependent, Recreational Central Nervous System Depressant Users · Phase 1 · completed
- NCT05478174 — Efficacy and Safety of HSK3486 Compared to Propofol for Adults Undergoing Elective Surgery With General Anesthesia · Phase 3 · completed
Other Sichuan Haisco Pharmaceutical Group Co., Ltd trials
Trials by the same sponsor.
- NCT04540016 — Mass Balance and Biotransformation of [14C]HSK7653 in Human · Phase 1 · completed
- NCT04564872 — HSK7653 Metformin Add-on Study in Patients With Type 2 Diabetes Mellitus · Phase 3 · completed
- NCT04556851 — HSK7653 Treatment in Patients With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise · Phase 3 · completed
- NCT04110886 — Safety, Tolerability, and Pharmacokinetics of HSK21542 in Healthy Volunteers · Phase 1 · completed
- NCT04595916 — Efficacy and Safety of Polyene Phosphatidylcholine in Treatment of Patients With Acute Drug-induced Liver Injury · Phase 4 · completed
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 NCT04142970 (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 Sichuan Haisco Pharmaceutical Group Co., Ltd
- Last refreshed: 19 December 2020
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/NCT04142970.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing