Clinical Trials

Inclusion Criteria:

1. Aged ≥ 18 years of age at the time of signing informed consent.

2. Non-dialysis dependent chronic kidney disease, stages 2-5, defined as eGFR < 90mL/min/1.73m2 using the 2021 CKD-EPI formula

3. Women: Hemoglobin < 10.5 g/dL; Men: Hemoglobin < 11.0 g/dL

4. Serum ferritin ≥ 100 μg/L at Screening

5. Transferrin saturation ≤ 35%

6. Body mass index (BMI) of 18.5 to 45.0 kg/m2, inclusive, at screening

7. Aspartate aminotransferase (AST) and alanine transaminase (ALT) < 2× upper limit of normal (ULN) at Screening.

8. Total and direct bilirubin < ULN at Screening.

Exclusion Criteria:

1. Treatment within 2 days prior to screening with oral iron or iron-containing
supplements. Participants may be considered for the study if they undergo a 2-day
washout period prior to signing the informed consent form (ICF) and screening for oral
iron or iron-containing supplements.

2. Treatment within 30 days prior to screening with one of the following anemia
treatments: erythropoietin-stimulating agent or IV iron. Participants may be
considered for the study if they undergo a 30-day washout period prior to signing the
informed consent form (ICF) and screening for erythropoietin-stimulating agent or IV
iron.

3. Acute dialysis or acute kidney injury within 12 weeks prior to screening or expected
need to start dialysis within 12 weeks of screening.

4. Hospitalization for a cardiovascular, renal, or cardiorenal condition within 30 days
prior to screening.

5. Positive direct antiglobulin test with reactive eluate at screening or active
hemolytic anemia.

6. History of hereditary hemochromatosis.

7. History of hemoglobinopathy or intrinsic red blood cell defect associated with anemia.

8. History of total splenectomy.

9. Hematopoietic stem cell or solid organ transplant within the past 10 years.

10. Medical history of anemia from Vitamin B12 or folate deficiency, infection, or
bleeding in the 3 months prior to screening

11. Blood transfusion within 3 months of screening

12. Stroke, myocardial infarction, deep venous thrombosis, pulmonary or arterial embolism
within 6 months prior to Screening

13. If female, pregnant or breastfeeding.

14. Any major surgery within 8 weeks before Screening or incomplete recovery from any
previous surgery.

15. History of malignancy within the last 3 years. The following history/concurrent
conditions are allowed: basal or squamous cell carcinoma, carcinoma in situ of the
cervix, carcinoma in situ of the breast, histologic finding of prostate cancer (T1a or
T1b using the tumor, nodes, metastasis [TNM] clinical staging system). A history of
completed treatment (medical or surgical) of Stage 1-2 cancers may be permitted with
prior Sponsor agreement.

16. Participation in any other clinical protocol or investigational trial that involves
administration of experimental therapy and/or therapeutic devices within 30 days of
Screening

17. A history or known allergic reaction to any investigational product excipients or
history of anaphylaxis to any food or drug

18. History of anti-drug antibody formation

19. History of inadequately controlled heart disease (New York Heart Association
Classification 3 or 4) and/or have a history of left ventricular ejection fraction
< 35%

20. Uncontrolled fungal, bacterial, or viral infection (defined as ongoing signs/symptoms
related to the infection without improvement, despite appropriate treatment)

21. Human immunodeficiency virus positive, active Hepatitis B, or active Hepatitis C.

22. Uncontrolled diabetes mellitus or diabetes mellitus requiring initiation of insulin
therapy within 3 months of screening

23. Significant medical condition, laboratory abnormality, or psychiatric condition that
would prevent the patient from participating in the study.

24. Any condition or concomitant medication that would confound the ability to interpret
data from the study.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 3/14/2024. Questions regarding updates should be directed to the study team contact.