CompletedPhase 2

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

United States, China113 participantsStarted 2021-10-18

Plain-language summary

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

Who can participate

Age range

20 Years – 74 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Diagnosis of chronic kidney disease, not receiving dialysis, with an eGFR \<60 mL/min/1.73 m2.
. Baseline Hb level ≥ 7.5 g/dL and \<10.0 g/dL.
. TSAT ≥ 20% or ferritin ≥ 100 ng/mL at screening test
. Serum folate and vitamin B12 ≥ lower limit of normal at screening test
. AST and ALT ≤ 3×ULN.
. Total bilirubin ≤ 1.5×ULN.

Exclusion criteria

. Concurrent retinal neovascular lesions requiring treatment including proliferative diabetic retinopathy, exudative age-related macular degeneration, retinal vein occlusion, macular edema, etc.
. Anemia that is possibly mainly caused by concurrent autoimmune disease with inflammatory symptoms
. History of gastric/intestinal resection considered to affect the absorption of drugs in the gastrointestinal tract (excluding resection of gastric or colon polyps) or concurrent symptomatic gastroparesis despite being on treatment.
. Clinically significant bleeding (eg, requiring transfusion or drop in Hb of ≥ 2g/dL) within 4 weeks of first dose; no bleeding diathesis or risk of bleeding that has not been medically or surgically corrected at least 4 weeks prior to first dose of study drug.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety Evaluations

Timeframe: Up to 17 weeks

Rate of rise in hemoglobin for each of 3 dose levels as compared with placebo from baseline to 5 weeks after TIW oral dosing

Timeframe: Up to 5 weeks after dosing

Trial details

NCT IDNCT05035641

SponsorKind Pharmaceuticals LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-07-05

View on ClinicalTrials.gov More Renal Anemia trials