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.
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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…
Contacts

Yusha Zhu, MD, PhD

646-725-2552

yushazhu@kindpharmaceutical.com

CONTACT