Who is sponsoring NCT04079257?

NCT04079257 is sponsored by Radboud University Medical Center.

What drugs are being tested in NCT04079257?

Interventions in NCT04079257: Blood collection for measurement of eculizumab peak concentrations.

What condition does NCT04079257 study?

NCT04079257 studies Paroxysmal Nocturnal Hemoglobinuria, Eculizumab, PK-PD.

Is NCT04079257 still recruiting?

NCT04079257 is currently completed. Last updated 24 August 2022.

Last reviewed 2022-08-24 · How we verify

NCT04079257: PREPARE

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

The Pharmacokinetics and Pharmacodynamics of Eculizumab in Patients With Paroxysmal Nocturnal Hemoglobinuria

Completed Last updated 24 August 2022

What this trial tests

trial testing Blood collection for measurement of eculizumab peak concentrations in Paroxysmal Nocturnal Hemoglobinuria in 27 participants. Completed in 1 July 2022.

Timeline

23 February 2021

Primary endpoint
1 July 2022

1 July 2022

Quick facts

Lead sponsor	Radboud University Medical Center
Status	Completed
Study type	OBSERVATIONAL
Enrollment	27
Start date	23 February 2021
Primary completion	1 July 2022
Estimated completion	1 July 2022
Sites	1 location across Netherlands

Drugs / interventions tested

Blood collection for measurement of eculizumab peak concentrations

Conditions studied

Paroxysmal Nocturnal Hemoglobinuria — all drugs for Paroxysmal Nocturnal Hemoglobinuria →
Eculizumab — all drugs for Eculizumab →
PK-PD — all drugs for PK-PD →

Sponsor

Radboud University Medical Center

Who can join

18 and older, any sex, with Paroxysmal Nocturnal Hemoglobinuria or Eculizumab. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Because of the inter and intra individual variability in pharmacokinetics and pharmacodynamics of eculizumab in PNH patients, a tailored treatment approach for the individual is probably preferable. The starting point of a robust tailored dosing approach for eculizumab is the development of a population pharmacokinetic-pharmacodynamic model. In this cross-sectional observational pharmacokinetic and pharmacodynamic study, trough and peak concentrations of eculizumab are measured to describe the pharmacokinetics and complement activation markers to describe the pharmacodynamics.

Publications & conference data

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

Treatment of Rare Inflammatory Kidney Diseases: Drugs Targeting the Terminal Complement Pathway.
Anliker-Ort M, Dingemanse J, van den Anker J, Kaufmann P. · · 2020 · cited 33× · PMID 33362783 · DOI 10.3389/fimmu.2020.599417
Emerging Role of C5 Complement Pathway in Peripheral Neuropathies: Current Treatments and Future Perspectives.
Giorgio C, Zippoli M, Cocchiaro P, Castelli V, et al · · 2021 · cited 29× · PMID 33917266 · DOI 10.3390/biomedicines9040399
Model-Informed Precision Dosing of Eculizumab in Patients with Paroxysmal Nocturnal Hemoglobinuria.
Ter Avest M, Langemeijer SMC, van den Heuvel LPWJ, Baas LM, et al · · 2025 · PMID 40560515 · DOI 10.1007/s40262-025-01536-x

Verify or expand the search:

Other recruiting trials for Paroxysmal Nocturnal Hemoglobinuria

Currently open trials in the same condition.

NCT07457151 — Danicopan PMS in Korea · recruiting
NCT07154745 — A Study to Evaluate How Pozelimab + Cemdisiran Combination Therapy Works in Adult Patients With Paroxysmal Nocturnal Hem · Phase 3 · recruiting
NCT07470762 — Study of Safety and Efficacy of HS-10542 in Patients With Paroxysmal Nocturnal Hemoglobinuria · Phase 1, PHASE2 · recruiting
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

Other Radboud University Medical Center trials

Trials by the same sponsor.

NCT07485569 — Drug Repurposing in Thyroid Carcinoma: a Feasibility Trial · Phase 1 · not yet recruiting
NCT07514325 — MR-guided Adaptive Stereotactic Radiotherapy for Endometrial Cancer · NA · not yet recruiting
NCT07530263 — Deposition of Inhaled Liposomal Amphotericin B in Chronic Pulmonary Aspergillosis (CPA) · Phase 1 · not yet recruiting
NCT07532577 — Intranasal Insulin to Prevent Intensive Care Unit Delirium · Phase 2, PHASE3 · not yet recruiting
NCT07504172 — Real-world Effectiveness and Dosing Patterns of Tirzepatide in People With Obesity · 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 NCT04079257 (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 Radboud University Medical Center
Last refreshed: 24 August 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/NCT04079257.

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