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Study of DISC-0974 to Assess the Safety, Tolerability, PK and PD of DISC-0974 in Participants With CKD and Anemia
About
Brief Summary
This Phase 1b study of DISC-0974 will assess the safety, tolerability, pharmacokinetics (PK) and Pharmacodynamics (PD) of DISC-0974 in adult participants with Non-Dialysis Dependent Chronic Kidney Disease and Anemia.
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
Inclusion criteria:
- Aged ≥18 years of age at the time of signing informed consent.
- Non-dialysis dependent chronic kidney disease, stages 2-5, defined as eGFR <90 mL/min/1.73m2 using the 2021 CKD-EPI formula
- Hemoglobin ≤11.0 g/dL
- Serum ferritin ≥75 μg/L at Screening
- Transferrin saturation ≤35%
- Body mass index (BMI) of 18.5 to 45.0 kg/m2, inclusive, at screening
- Aspartate aminotransferase (AST) and alanine transaminase (ALT) <2× upper limit of normal (ULN) at Screening.
- Total and direct bilirubin <ULN at Screening.
Exclusion Criteria:
- 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.
- 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.
- Acute dialysis or acute kidney injury within 12 weeks prior to screening or expected need to start dialysis within 12 weeks of screening.
- Hospitalization for a cardiovascular, renal, or cardiorenal condition within 30 days prior to screening.
- Positive direct antiglobulin test with reactive eluate at screening or active hemolytic anemia.
- History of hereditary hemochromatosis.
- History of hemoglobinopathy or intrinsic red blood cell defect associated with anemia.
- History of total splenectomy.
- Hematopoietic stem cell or solid organ transplant within the past 10 years.
- Medical history of anemia from Vitamin B12 or folate deficiency, infection, or bleeding in the 3 months prior to screening
- Blood transfusion within 3 months of screening
- Stroke, myocardial infarction, deep venous thrombosis, pulmonary or arterial embolism within 6 months prior to Screening
- If female, pregnant or breastfeeding.
- Any major surgery within 8 weeks before Screening or incomplete recovery from any previous surgery.
- 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.
- Participation in any other clinical protocol or investigational trial that involves administration of experimental therapy and/or therapeutic devices within 30 days of Screening
- A history or known allergic reaction to any investigational product excipients or history of anaphylaxis to any food or drug
- History of anti-drug antibody formation
- 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%
- Uncontrolled fungal, bacterial, or viral infection (defined as ongoing signs/symptoms related to the infection without improvement, despite appropriate treatment)
- Human immunodeficiency virus positive, active Hepatitis B, or active Hepatitis C.
- Uncontrolled diabetes mellitus or diabetes mellitus requiring initiation of insulin therapy within 3 months of screening
- Significant medical condition, laboratory abnormality, or psychiatric condition that would prevent the patient from participating in the study.
- Any condition or concomitant medication that would confound the ability to interpret data from the study.
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Study Stats
Protocol No.
23-5147
Category
Genitourinary Disorders
Principal Investigator
Contact
Location
- UCLA Westwood