NCT05515367

A Post Marketing Surveillance to Evaluate the Safety of Desidustat for the Treatment of Anemia in Subjects With Chronic Kidney Disease (CKD).(Real World Evidence Study)

A Phase 4,52 Week, Single Arm,Multicentre Post Marketing Surveillance to Evaluate the Safety of Desidustat for the Treatment of Anemia in Subjects With Chronic Kidney Disease (CKD).

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,004 (estimated)
• Sponsor: Zydus Lifesciences Limited · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

A Phase 4, 52 week, single arm, multicentre post marketing surveillance to evaluate the safety of Desidustat for the treatment of anemia in subjects with chronic kidney disease (CKD)

Detailed description

The study is being planned to evaluate long term safety of Desidustat with CKD patient. Total 1004 population i.e 502 dialysis dependent, 502 dialysis independent.

Conditions

• Chronic Kidney Diseases
• Anemia of Chronic Kidney Disease

Interventions

Type	Name	Description
DRUG	Desidustat	Oral tablet

Timeline

• Start date: 2023-04-20
• Primary completion: 2025-06-30
• Completion: 2025-11-30
• First posted: 2022-08-25
• Last updated: 2025-01-22

Locations

1 site across 1 country: India