A Study of AND017 to Evaluate Efficacy and Safety in Patients With Anemia Due to Non-Dialysis-Dependent Chronic Kidney Disease (NDD-CKD)
Recruiting
Phase 3
Interventional Study
Anemia Due to Chronic Kidney Disease
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 240 (estimated)
- Sponsor
- Kind Pharmaceuticals LLC · Industry
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About This Trial
This is a Phase III, randomized, open-label, active-controlled study to evaluate the safety and efficacy of AND017 in non-dialysis-dependent (NDD)-CKD patients compared with the active control, ESA treatment
Trial Locations
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Eligibility Criteria
Key Inclusion Criteria:
* A diagnosis of CKD confirmed at screening, KDOQI CKD stage 3, 4, or 5 defined by estimated Glomerular Filtration Rate (eGFR) using the CKD Epidemiology Collaboration (EPI) formula.
* Not on dialysis and no clinical evidence of impending need to initiate dialysis during the…
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