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NCT04313153COMPLETEDanonymous

Phase 3b, Randomized, Open-label, Active-controlled Trial Evaluating the Efficacy and Safety of Oral Vadadustat Once Daily (QD) and Three Times Weekly (TIW) for the Maintenance Treatment of Anemia in Hemodialysis Subjects Converting From Erythropoiesis-Stimulating Agents (ESAs)

Sponsor

Source record

Akebia Therapeutics

Phase

Source record

Phase 3b

Modality

AI-normalized

small molecule

Target

AI-normalized

Anemia in Hemodialysis Patients

Indication / condition

AI-normalized

Anemia

Intervention

Source record

Vadadustat, Darbepoetin alfa

Source & freshness

Source record

NCT ID

NCT04313153

Original source

ClinicalTrials.gov

Source last updated

May 22, 2025

Ingested at

May 31, 2026

Internal sync

Jun 05, 2026

Model version

trialsignal-ai-v1

Normalized confidence

88%

Validation status

validated

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View original source fields

NCT ID

NCT04313153

Title

Phase 3b, Randomized, Open-label, Active-controlled Trial Evaluating the Efficacy and Safety of Oral Vadadustat Once Daily (QD) and Three Times Weekly (TIW) for the Maintenance Treatment of Anemia in Hemodialysis Subjects Converting From Erythropoiesis-Stimulating Agents (ESAs)

Sponsor

Akebia Therapeutics

Status

COMPLETED

Phase

Phase 3b

Condition raw

Anemia

Condition normalized

Anemia

Modality raw

Anemia

Modality normalized

small molecule

Target raw

Anemia in Hemodialysis Patients

Target normalized

Anemia in Hemodialysis Patients

Interventions

Vadadustat, Darbepoetin alfa

Public preview

Source record

This clinical trial evaluated the efficacy and safety of vadadustat, an oral medication, compared to darbepoetin alfa, an established erythropoiesis-stimulating agent (ESA), for maintaining hemoglobin levels in hemodialysis patients transitioning from ESA therapy. The study involved 319 participants and was conducted by Akebia Therapeutics in collaboration with Otsuka Pharmaceutical Development & Commercialization.

AI-generated analysis supports research triage only. Verify source records, publications, sponsor disclosures and IP databases before making diligence decisions. Model: trialsignal-ai-v1.

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TrialSignal

Clinical trial intelligence report

Phase 3b, Randomized, Open-label, Active-controlled Trial Evaluating the Efficacy and Safety of Oral Vadadustat Once Daily (QD) and Three Times Weekly (TIW) for the Maintenance Treatment of Anemia in Hemodialysis Subjects Converting From Erythropoiesis-Stimulating Agents (ESAs)

Source-linked diligence brief with registry provenance, taxonomy normalization and premium analytical context.

Generated

Jun 13, 2026

NCT ID

NCT04313153

Status

COMPLETED

Phase

Phase 3b

Sponsor

Akebia Therapeutics

Executive brief

Investment-Ready Snapshot

This clinical trial evaluated the efficacy and safety of vadadustat, an oral medication, compared to darbepoetin alfa, an established erythropoiesis-stimulating agent (ESA), for maintaining hemoglobin levels in hemodialysis patients transitioning from ESA therapy. The study involved 319 participants and was conducted by Akebia Therapeutics in collaboration with Otsuka Pharmaceutical Development & Commercialization.

Source & freshness

Provenance

SourceClinicalTrials.gov
Source updatedMay 22, 2025
Internal syncJun 05, 2026
Model versiontrialsignal-ai-v1

https://clinicaltrials.gov/study/NCT04313153

Indication

Anemia

Modality

small molecule

Target

Anemia in Hemodialysis Patients

Intervention

Vadadustat, Darbepoetin alfa

Source record

Protocol Description

Detailed source ingestion pending.

Source record

Outcome Measures

Detailed source ingestion pending.

Source record

Eligibility

Detailed source ingestion pending.

AI analysis

Known Results And Readout Context

Detailed source ingestion pending.

IP intelligence

Patent And IP Landscape

Detailed source ingestion pending.

Source record

Contacts

Detailed source ingestion pending.