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

• Status: Recruiting
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kind Pharmaceuticals LLC

Criteria

Important Inclusion Criteria:

1. Non-dialysis-dependent renal anemia patients who are naïve to ESA and prolyl-hydroxylase inhibitors.

2. Baseline Hb level ≥ 8 g/dL and <10.0 g/dL.

3. No iron deficiency and no other cause for anemia other than CKD.

4. TSAT ≥ 20% and ferritin ≥ 100 ng/mL at screening test

5. Serum folate and vitamin B12 ≥ lower limit of normal at screening test

Important Exclusion Criteria:

1. Concurrent retinal neovascular lesions requiring treatment including proliferative diabetic retinopathy, exudative age-related macular degeneration, retinal vein occlusion, macular edema, etc.

2. Concurrent autoimmune disease with inflammatory symptoms that is possibly the principal cause of anemia.

3. History of gastric/intestinal resection considered influential on the absorption of drugs in the gastrointestinal tract or concurrent gastroparesis.

4. 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.

5. Uncontrolled hypertension (more than one-third of identifiable diastolic blood pressure values >90 mmHg within 16 weeks prior to and including the screening assessment).

6. Concurrent congestive heart failure (New York Heart Association [NYHA] Class III or higher).

7. History of stroke, transient ischemic attack, myocardial infarction, thromboembolic event, pulmonary embolism, or lung infarction within 24 weeks before the screening assessment.

8. Concurrent anemia due to another cause other than renal anemia

9. Known hemosiderosis, hemochromatosis or hyper-coagulable condition

10. Patients that have major surgery planned during the study period.

11. Having undergone blood transfusion and/or a surgical procedure within 8 weeks before the screening assessment.

12. Having undergone a kidney transplantation.

13. History of a seizure disorder or any occurrence of seizures in the past