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)
Recruiting
Phase 4
Interventional Study
Chronic Kidney Diseases
Anemia of Chronic Kidney Disease
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 85
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 1,004 (estimated)
- Sponsor
- Zydus Lifesciences Limited · Industry
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About This Trial
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)
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Male or female, ≥ 18 years of age.
2. Current clinical diagnosis of anemia due to CKD, baseline hemoglobin concentrations must be 7.0-11.0 g/dL (both inclusive) before the enrolment.
3. Ability to understand and give informed consent for participation.
4. No significant folat…
Contacts