NCT02965040

A Phase 1 Study of Roxadustat in Subjects With Different Degrees of Renal Function

Completed Phase 1 Last updated 12 February 2020

What this trial tests

Phase 1 trial testing Roxadustat in Normal Renal Function in 34 participants. Completed in 11 December 2017.

Timeline

12 December 2016

Primary endpoint
4 December 2017

11 December 2017

Quick facts

Lead sponsor	Astellas Pharma Europe B.V.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	34
Start date	12 December 2016
Primary completion	4 December 2017
Estimated completion	11 December 2017
Sites	2 locations across United Kingdom, Germany

Drugs / interventions tested

• Roxadustat (ROXADUSTAT) — full drug profile →

Conditions studied

• Normal Renal Function — all drugs for Normal Renal Function →
• Impaired Renal Function — all drugs for Impaired Renal Function →

Sponsor

Astellas Pharma Europe B.V. — full company profile →

Who can join

Adults 18 to 75, any sex, with Normal Renal Function or Impaired Renal Function. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

For subjects with normal renal function or severely impaired renal function, this study will evaluate the pharmacokinetics of roxadustat and its main metabolites in plasma and urine.

For subjects with end stage renal disease (ESRD) on continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD), this study will evaluate the pharmacokinetics of roxadustat and its main metabolites in plasma, urine and dialysate.

For subjects with ESRD on hemodialysis (HD) or hemodiafiltration (HDF), this study will evaluate the pharmacokinetics of roxadustat and its main metabolites in plasma, urine and dialysate and also the effect of dialysis on the pharmacokinetics of roxadustat and its main metabolites.

Publications & conference data

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

1. The hypoxia-adenosine link during inflammation.
   Bowser JL, Lee JW, Yuan X, Eltzschig HK. · · 2017 · cited 90× · PMID 28798196 · DOI 10.1152/japplphysiol.00101.2017
2. Effect of Kidney Function and Dialysis on the Pharmacokinetics and Pharmacodynamics of Roxadustat, an Oral Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitor.
   Groenendaal-van de Meent D, Kerbusch V, Kaspera R, Barroso-Fernandez B, et al · · 2021 · cited 14× · PMID 33165773 · DOI 10.1007/s13318-020-00658-w
3. A critical review of Roxadustat formulations, solid state studies, and analytical methodology.
   Mahajan R, Samanthula G, Srivastava S, Asthana A. · · 2023 · cited 3× · PMID 37346363 · DOI 10.1016/j.heliyon.2023.e16595
4. The Efficacy and Safety of Roxadustat for Anemia in Hemodialysis Patients with Chronic Kidney Disease: A Meta-Analysis of Randomized Controlled Trials.
   Geng Y, Zhang S, Cao Z, Tang J, et al · · 2024 · cited 2× · PMID 39771061 · DOI 10.3390/toxics12120846