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NCT04935294
Study of Danicopan in Participants With Normal Kidney Function and Participants With Kidney Dysfunction
Phase 1 trial testing Danicopan in Healthy in 16 participants. Completed in 29 May 2018.
29 May 2018
Quick facts
| Lead sponsor | Alexion Pharmaceuticals, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 16 |
| Start date | 24 January 2018 |
| Primary completion | 29 May 2018 |
| Estimated completion | 29 May 2018 |
| Sites | 4 locations across United States |
Drugs / interventions tested
- Danicopan — full drug profile →
Conditions studied
- Healthy — all drugs for Healthy →
- Renal Dysfunction — all drugs for Renal Dysfunction →
Sponsor
Alexion Pharmaceuticals, Inc. — full company profile →
Who can join
Adults 18 to 75, any sex, with Healthy or Renal Dysfunction. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This was an open-label, nonrandomized, multi-center, single-dose, parallel group study to evaluate the effect of severe renal impairment (RI) on the safety, tolerability, pharmacokinetics, and pharmacodynamics of danicopan (ACH-0144471) compared to demographically-matched healthy participants with normal renal function.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04935294
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Danicopan
Trials testing the same drug.
- NCT07413250 — Assess Long-Term Safety of Danicopan Add-on Therapy in Participants With Paroxysmal Nocturnal Hemoglobinuria: Analysis o · active not recruiting
- NCT07413679 — Long-term Safety of Danicopan: IPIG Registry-based Cohort Study · active not recruiting
- NCT06449001 — Study of Danicopan as Add-on Treatment to Ravulizumab or Eculizumab in Pediatric Participants With PNH Who Have Clinical · Phase 3 · recruiting
- NCT05389449 — A Long-term Safety and Efficacy Study of Danicopan as an Add-on Therapy to Complement Component 5 Inhibitor (C5i) in Par · Phase 3 · active not recruiting
- NCT05019521 — A Study of Danicopan in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration · Phase 2 · terminated
Other recruiting trials for Healthy
Currently open trials in the same condition.
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Other Alexion Pharmaceuticals, Inc. trials
Trials by the same sponsor.
- NCT06015750 — Mitigate Immune-Mediated Loss of Therapeutic Response to Asfotase Alfa (STRENSIQ®) for Hypophosphatasia · Phase 4 · withdrawn
- NCT07352423 — Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of ALXN2230 in Healthy Participants · Phase 1 · recruiting
- NCT07221838 — A Study to Investigate OCS Tapering in Adult Participants With Generalized Myasthenia Gravis Treated With Ravulizumab · Phase 4 · recruiting
- NCT07413250 — Assess Long-Term Safety of Danicopan Add-on Therapy in Participants With Paroxysmal Nocturnal Hemoglobinuria: Analysis o · active not recruiting
- NCT07308574 — Post-Marketing Clinical Study of Ravulizumab in Participants With Clinical aHUS · Phase 4 · 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 NCT04935294 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Alexion Pharmaceuticals, Inc.
- Last refreshed: 23 June 2021
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/NCT04935294.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing