Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2026-02-26 @ 12:03 PM
Study NCT ID:
NCT02021318
Status:
COMPLETED
Last Update Posted:
2024-11-14
First Post:
2013-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Roxadustat in the Treatment of Anemia in Chronic Kidney Disease (CKD) Patients, Not on Dialysis, in Comparison to Darbepoetin Alfa
Sponsor:
Astellas Pharma Europe B.V.
Organization:
Study Overview
Official Title:
A Phase 3, Randomized, Open-Label, Active-Controlled Study to Evaluate the Efficacy and Safety of Roxadustat in the Treatment of Anemia in Chronic Kidney Disease Patients Not on Dialysis
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Dolomites
Brief Summary:
The primary objective of this study was to evaluate the efficacy of roxadustat compared to darbepoetin alfa in the treatment of anemia in nondialysis-dependent chronic kidney disease (NDD CKD) participants.
Detailed Description:
This was a phase 3, multicenter, randomized, open-label, active-controlled study. The study was planned to provide key efficacy and safety data for the approval of roxadustat in the treatment of anemia associated with CKD. Participants assigned to roxadustat treatment were administered roxadustat orally as a combination of tablets of different strengths. Participants assigned to darbepoetin alfa treatment were administered darbepoetin alfa subcutaneously or intravenously.
The study consisted of 3 study periods:
* Screening period: up to 6 weeks
* Treatment period: 104 weeks
* Follow-up period: 4 weeks until planned study end (end of year 2)
The study consisted of 3 study periods:
* Screening period: up to 6 weeks
* Treatment period: 104 weeks
* Follow-up period: 4 weeks until planned study end (end of year 2)
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2013-000951-42 | EUDRACT_NUMBER | None | View |