Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03457701 · ClinicalTrials.gov registry record · Phase 2
Anemia Studies in CKD: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat- Iron (ASCEND: Fe)
A Phase 2 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
NCT03457701 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 15 participants.
The verdict
NCT03457701, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
Study Summary
Daprodustat administration has the potential, by virtue of increasing hypoxia-inducible factor (HIF) levels, to increase oral iron absorption and incorporation into hemoglobin (Hgb). Therefore, the purpose of this study is to compare the effect of daprodustat to rhEPO (i.e., epoetin alfa or darbepoetin alfa) on non-heme oral iron absorption using stable isotopic iron (57Fe and 58Fe) by measuring incorporation of iron in erythrocytes. This study will be a randomized, repeat dose, open label, two period cross-over study in adult, male and female participants with anemia associated with chronic kidney disease who are not on dialysis currently treated with stable doses less than or equal to (\<=) 50 percent (%) change in 4-weekly dose) for at least 8 weeks prior to and including the screening period, of rhEPO (i.e., epoetin alfa or darbepoetin alfa). Sufficient participants will be enrolled such that at least 12 participants comprise the Evaluable Population. The study will compare the fractional iron absorption between treatment arms (daprodustat and rhEPO \[i.e., epoetin alfa or darbepoetin alfa\]) and will evaluate the difference is equal/not equal to zero.
Interventions
- DRUG Daprodustat
- DRUG rhEPO
- DRUG Ferrous sulfate containing the stable iron isotope (57Fe)
- DRUG Ferrous sulfate containing the stable iron isotope (58Fe)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2019-07-30 |
| Est. Completion | 2022-07-05 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03457701
The ClinicalTrials.gov registry entry for NCT03457701 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Daprodustat is the first listed.
NCT03457701 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03457701 about?
NCT03457701 is a clinical study titled "Anemia Studies in CKD: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat- Iron (ASCEND: Fe)". Daprodustat administration has the potential, by virtue of increasing hypoxia-inducible factor (HIF) levels, to increase oral iron absorption and incorporation into hemoglobin (Hgb). Therefore, the purpose of this study is to compare the effect of daprodustat to rhEPO (i.e., epoetin alfa or darbepoe...
What is the current status of trial NCT03457701?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2019-07-30. Estimated completion is 2022-07-05.
What interventions are being tested in trial NCT03457701?
The interventions under investigation include: Daprodustat (DRUG), rhEPO (DRUG), Ferrous sulfate containing the stable iron isotope (57Fe) (DRUG), Ferrous sulfate containing the stable iron isotope (58Fe) (DRUG).
Who is sponsoring clinical trial NCT03457701?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.