RecruitingPhase 4NCT05515367

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).


Sponsor

Zydus Lifesciences Limited

Enrollment

1,004 participants

Start Date

Apr 20, 2023

Study Type

INTERVENTIONAL

Conditions

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)


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This real-world surveillance study tracks the safety of desidustat — an oral medication recently approved in India for treating anemia in patients with chronic kidney disease (CKD). Anemia in CKD occurs because damaged kidneys produce less of a hormone (erythropoietin) that stimulates red blood cell production. This study monitors patients in real-world clinical practice. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with anemia caused by chronic kidney disease - Your hemoglobin (red blood cell level) is between 7.0 and 11.0 g/dL - You are able to understand the study and give informed consent - You do not have significant vitamin B12 or folate deficiency - If you are on dialysis, you have been receiving it at least twice a week for 12 weeks **You may NOT be eligible if...** - Your anemia is caused by something other than CKD (such as iron deficiency, B12 deficiency, or bleeding) - You have severe uncontrolled heart, liver, or blood pressure conditions - You are pregnant or breastfeeding - You are taking medications that could interfere with the study drug Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDesidustat

Oral tablet


Locations(1)

Indira Gandhi Institute of Medical Sciences

Sheikhpura, Bihar, India

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NCT05515367


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