CompletedPhase 2

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

United States113 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

Age range20 Years – 74 Years

SexALL

See this in plain English?

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

✓. 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.

✕. 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.
✕. Uncontrolled hypertension defined as patients with hypertension having more than one of three diastolic blood pressure values \>95 mmHg and each test at least 5 min apart during the screening assessment.
✕. Concurrent congestive heart failure (New York Heart Association \[NYHA\] Class III or higher).
✕. History of stroke, transient ischemic attack, myocardial infarction, thromboembolic event, pulmonary embolism, or lung infarction within 24 weeks before the screening assessment.
✕. Concurrent anemia due to another cause other than renal anemia

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

NCT IDNCT05035641

SponsorKind Pharmaceuticals LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-07-05

Who can participate

Age range20 Years – 74 Years

SexALL

See this in plain English?

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

✓. 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.

✕. 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.
✕. Uncontrolled hypertension defined as patients with hypertension having more than one of three diastolic blood pressure values \>95 mmHg and each test at least 5 min apart during the screening assessment.
✕. Concurrent congestive heart failure (New York Heart Association \[NYHA\] Class III or higher).
✕. History of stroke, transient ischemic attack, myocardial infarction, thromboembolic event, pulmonary embolism, or lung infarction within 24 weeks before the screening assessment.
✕. Concurrent anemia due to another cause other than renal anemia