NCT05035641

A Study of AND017 to Treat Anemia in Non-dialysis-Dependent Chronic Kidney Disease (NDD-CKD) Patients

A Pilot Phase II Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled, Dose-Ranging, Safety and Efficacy Study of Oral AND017 to Treat Anemia in Nondialysis-Dependent Chronic Kidney Disease (NDD-CKD) Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 113 (actual)
• Sponsor: Kind Pharmaceuticals LLC · Industry
• Sex: All
• Age: 20 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

This is a pilot phase II study to evaluate the safety and efficacy of AND017 in NDD-CKD patients

Detailed description

This is a pilot phase 2, multicenter, randomized, parallel-group, double-blind, placebo-controlled, dose-ranging, safety and efficacy study of oral AND017 to treat anemia in non-dialysis-dependent chronic kidney disease patients.

Conditions

• Renal Anemia

Interventions

Type	Name	Description
DRUG	AND017	Orally, 3 times per week in Period 1 and randomize to TIW or QW group at the same dose in Period 2
DRUG	Placebo	Orally, 3 times per week

Timeline

• Start date: 2021-10-18
• Primary completion: 2023-07-05
• Completion: 2023-07-24
• First posted: 2021-09-05
• Last updated: 2023-10-04

Locations

8 sites across 2 countries: United States, China

Regulatory

• FDA-regulated drug study