NCT05265325

A Study of AND017 to Treat Anemia in Chronic Kidney Disease Patients on Dialysis

A Phase 2, Multicenter, Open-label, Randomized, Active-Controlled Study of Efficacy and Safety of AND017 in the Treatment of Anemia in Patients With Chronic Kidney Disease on Dialysis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 175 (actual)
• Sponsor: Kind Pharmaceuticals LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II study to evaluate the safety and efficacy of AND017 in renal anemia patients on dialysis

Detailed description

This is a Phase II study to assess the safety and efficacy of AND017 in patients with CKD who are anemic and on dialysis.

Conditions

• Renal Anemia

Interventions

Type	Name	Description
DRUG	AND017 capsules TIW	Orally, 3 times per week in Period 1 and dose adjustment in Period 2 at 2 mg/4 mg and 2-weeks interval according to Hb levels
DRUG	AND017 capsules QW	Orally, once per week in Period 1 and dose adjustment in Period 2 at 4 mg/8 mg and 2-weeks interval according to Hb levels
DRUG	epoetin alfa, darbepoetin alfa, Mircera®, or their biosimilars	Dose regimen and adjustment rules according to the USPI or SmPC or local practice

Timeline

• Start date: 2023-05-03
• Primary completion: 2024-02-29
• Completion: 2024-04-25
• First posted: 2022-03-03
• Last updated: 2024-06-28

Locations

25 sites across 2 countries: United States, China

Regulatory

• FDA-regulated drug study