A Study of AND017 to Treat Anemia in Non-dialysis-Dependent Chronic Kidney Disease (NDD-CKD) Patients
A Study of AND017 to Treat Anemia in Non-dialysis-Dependent Chronic Kidney Disease (NDD-CKD) Patients
Brief 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.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date: October 18, 2021
Estimated Primary Completion Date: September 2022
Estimated Study Completion Date: October 2022
Arm:
- Experimental: AND017 Dose A
- Experimental: AND017 Dose B
- Experimental: AND017 Dose C
- Placebo Comparator: Placebo
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Estimated enrolment | 88 |
| Actual Study start date | 18 October 2021 |
| Estimated Study Completion Date | 01 October 2022 |