ArticleClinical kidney journal2019
Effect of renal function and dialysis modality on daprodustat and predominant metabolite exposure.
Article in Clinical kidney journal, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 14 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Repeat-dose, Open-label, Parallel-group Study to Assess the Pharmacokinetics of GSK1278863 and Metabolites in Normal Subjects and Subjects With Impaired Renal Function
A Repeat-Dose, Open-Label, Parallel-Group Study to Assess the Pharmacokinetics of GSK1278863 and Metabolites in Subjects With End Stage Renal Disease Undergoing Peritoneal Dialysis
Who cites it
14 citing papers in PubMed.
- Integrated Population Pharmacokinetics of Daprodustat in Patients with Chronic Kidney Disease with Anemia.Clinical pharmacokinetics · 2024Trial
- A Single-Dose, Open-Label, Randomized, Two-Way Crossover Study in Healthy Japanese Participants to Evaluate the Bioequivalence and the Food Effect on the Pharmacokinetics of Daprodustat.Clinical pharmacology in drug development · 2020Trial
- Desidustat: a novel PHD inhibitor for the treatment of CKD-induced anemia.Frontiers in nephrology · 2024Review
- Chemistry, Analysis, and Biological Aspects of Daprodustat, A New Hypoxia Inducible Factor Prolyl Hydroxylase Inhibitor: A Comprehensive Review.Mini reviews in medicinal chemistry · 2024Review
- Investigation of the human metabolism and disposition of the prolyl hydrolase inhibitor daprodustat using IV microtracer with Entero-Test bile string.Pharmacology research & perspectives · 2023Article
- Daprodustat.Hospital pharmacy · 2023Review
- Pharmacokinetics of Daprodustat and Metabolites in Individuals with Normal and Impaired Hepatic Function.Clinical pharmacology in drug development · 2022Article
- Clinical Pharmacokinetics of Daprodustat: Results of an Absorption, Distribution, and Excretion Study With Intravenous Microtracer and Concomitant Oral Doses for Bioavailability Determination.Clinical pharmacology in drug development · 2021Article
- Anemia management for home dialysis including the new US public policy initiative.Kidney international supplements · 2021Article
- Hypoxia-inducible factor-prolyl hydroxylase inhibitors in the treatment of anemia of chronic kidney disease.Kidney international supplements · 2021Article
- Profile of Daprodustat in the Treatment of Renal Anemia Due to Chronic Kidney Disease.Therapeutics and clinical risk management · 2021Review
- Burden of Anemia in Chronic Kidney Disease: Beyond Erythropoietin.Advances in therapy · 2021Review
- Daprodustat: First Approval.Drugs · 2020Review
- An Integrated Dialysis Pharmacometric (IDP) Model to Evaluate the Pharmacokinetics in Patients Undergoing Renal Replacement Therapy.Pharmaceutical research · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundCurrent therapies for anemia of chronic kidney disease (CKD) include administration of supplemental iron (intravenous and/or oral), blood transfusions and replacement of erythropoietin through the administration of recombinant human erythropoietin (rhEPO) and rhEPO analogs, each with limitations. Daprodustat is an orally active, small molecule hypoxia-inducible factor-prolyl hydroxylase inhibitor that is currently in Phase 3 clinical studies. As it is well appreciated that the kidney represents a major route of elimination of many drugs, and daprodustat will be administered to patients with advanced CKD as well as patients with end-stage kidney disease, it is important to characterize the pharmacokinetic profile in these patient populations to safely dose this potential new medicine.
methodsThe primary objective of these studies, conducted under two separate protocols and with identical assessments and procedures, was to characterize the steady-state pharmacokinetics of daprodustat and the six predominant metabolites (i.e. metabolites present in the highest concentration in circulation) in subjects with normal renal function, anemic non-dialysis (ND)-dependent CKD subjects (CKD Stage 3/4) and anemic subjects on either hemodialysis (HD) or peritoneal dialysis (PD). All enrolled subjects were administered daprodustat 5 mg once daily for 14 days (all except HD subjects) or 15 days (for HD subjects). Blood, urine and peritoneal dialysate were collected at various times for measurement of daprodustat, predominant metabolite, erythropoietin and hepcidin levels.
resultsThe pharmacokinetic properties of steady-state daprodustat peak plasma concentration (Cmax), area under the plasma daprodustat concentration-time curve (AUC) and the time of Cmax (tmax) were comparable between all cohorts in this study. In addition, there was no clinically relevant difference in these properties in the HD subjects between a dialysis and ND day. For CKD Stage 3/4, HD (dialysis day) and PD subjects, the AUC of all daprodustat metabolites assessed was higher, while the
conclusionThese studies demonstrated no clinically meaningful change in the pharmacokinetic properties of daprodustat when administered to subjects with various degrees of renal impairment, while for CKD Stage 3/4, HD (dialysis day) and PD subjects, the
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.