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

NCT05265325 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 175

Last updated 2024-06-28

No results posted yet for this study

Summary

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

Conditions

  • Renal Anemia

Interventions

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

Sponsors & Collaborators

  • Kind Pharmaceuticals LLC

    lead INDUSTRY

Principal Investigators

  • Yusha Zhu, MD, PhD · Kind Pharmaceuticals LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-03
Primary Completion
2024-02-29
Completion
2024-04-25
FDA Drug
Yes

Countries

  • United States
  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05265325 on ClinicalTrials.gov