A Study of AND017 to Treat Anemia in Non-dialysis-Dependent Chronic Kidney Disease (NDD-CKD) Patients
Recruiting at 7 trial locations
QZ
YZ
Overseen ByYusha Zhu
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Kind Pharmaceuticals LLC
Prior Safety DataThis treatment has passed at least one previous human trial
Trial Summary
What is the purpose of this trial?
This trial is testing a new oral medication called AND017 to see if it can safely and effectively treat anemia in patients with chronic kidney disease who are not on dialysis.
Research Team
YZ
Yusha Zhu, MD PhD
Principal Investigator
Kind Pharmaceuticals LLC
Eligibility Criteria
Inclusion Criteria
TSAT ≥ 20% or ferritin ≥ 100 ng/mL at screening test
AST and ALT ≤ 3×ULN
You have chronic kidney disease, not receiving dialysis, with an eGFR <60 mL/min/1.
See 6 more
Exclusion Criteria
Anemia that is possibly mainly caused by concurrent autoimmune disease with inflammatory symptoms
Total bilirubin >1.5xULN, or AST>3xULN, or ALT>3xULN, or ALP>3xULN, or previous or concurrent serious liver disease (acute or active chronic hepatitis, cirrhosis, etc.) thought to be caused by ESAs.
Patients that have major surgery planned during the study period.
See 14 more
Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive oral AND017 or placebo to treat anemia in NDD-CKD patients
13 weeks
Weekly visits for monitoring
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Treatment Details
Interventions
- AND017
- Placebo
Participant Groups
4Treatment groups
Experimental Treatment
Placebo Group
Group I: AND017 Dose CExperimental Treatment1 Intervention
AND017 will be administrated orally at dose C
Group II: AND017 Dose BExperimental Treatment1 Intervention
AND017 will be administrated orally at dose B
Group III: AND017 Dose AExperimental Treatment1 Intervention
AND017 will be administrated orally at dose A
Group IV: PlaceboPlacebo Group1 Intervention
Placebo will be administrated orally
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Who Is Running the Clinical Trial?
Kind Pharmaceuticals LLC
Lead Sponsor
Trials
9
Recruited
640+
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