Study of DISC-0974 to Assess the Safety, Tolerability, PK and PD of DISC-0974 in Participants with CKD and Anemia

Phase 1

Recruiting

• Conditions: Chronic Kidney Diseases; Anemia of Chronic Kidney Disease
• Interventions: Drug: DISC-0974; Drug: Placebo

• Registration Number: NCT05745883
• Lead Sponsor: Disc Medicine, Inc

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-16
• Study First Submitted QC: 2023-02-16
• Study First Posted: 2023-02-27
• Study Start: 2023-04-04
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-13
• Last Update Posted: 2024-11-15
• Primary Completion: 2025-09
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

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. Between screening and 2 days prior to baseline visit, participants may continue oral iron or iron-containing supplements at the discretion of the Investigator, but any study-related lab draws will require a 48-hour washout from oral iron
2. Treatment within 30 days prior to screening with one of the following anemia treatments: blood transfusion, ESAs, or IV iron. Participants may be considered for the study if they undergo a 30-day washout period prior to signing the ICF and screening for erythropoietin-stimulating agents or IV iron
3. Acute dialysis or acute kidney injury within 12 weeks prior to screening or expected need to start dialysis within 24 weeks of screening
4. Hospitalization for a CV, renal, or cardiorenal condition within 30 days prior to screening
5. Positive direct antiglobulin test with reactive eluate at screening or active hemolytic anemia. This test can be performed prior to other screening procedures after the participant is consented for the prescreening testing
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 B12 or folate deficiency, infection, or bleeding in the 3 months prior to screening
11. Stroke, myocardial infarction, deep venous thrombosis, pulmonary or arterial embolism within 6 months prior to screening
12. If female, pregnant or breastfeeding
13. Any major surgery within 8 weeks before screening or incomplete recovery from any previous surgery
14. History of malignancy within the last 3 years. The following history/concurrent conditions are allowed: basal or squamous cell carcinoma skin cancer, 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
15. Participation in any other clinical protocol or investigational study that involves administration of experimental therapy and/or therapeutic devices within 30 days of screening
16. A history or known allergic reaction to any investigational product excipients or history of anaphylaxis to any food or drug
17. History of anti-drug antibody formation
18. History of inadequately controlled heart disease (New York Heart Association Classification 3 or 4) and/or have a known left ventricular ejection fraction <35%
19. Uncontrolled fungal, bacterial, or viral infection (defined as ongoing signs/symptoms related to the infection without improvement, despite appropriate treatment)
20. Human immunodeficiency virus positive, active hepatitis B, or active hepatitis C
21. Uncontrolled diabetes mellitus (defined as diabetes mellitus requiring initiation of insulin therapy within 3 months of screening)
22. Significant medical condition, laboratory abnormality, or psychiatric condition that would prevent the patient from participating in the study
23. Any condition or concomitant medication that would confound the ability to interpret data from the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Phase 1b Single Dose	DISC-0974	Single dose of DISC-0974
Single Dose of Placebo	Placebo	Single dose of placebo
Phase 1b Multiple Doses	DISC-0974	Multiple doses of DISC-0974
Multiple Doses of Placebo	Placebo	Multiple doses of placebo

Primary Outcome Measures

Name	Time	Method
Incidence of treatment-emergent adverse events	up to 145 days
Incidence of clinically abnormal vital signs	up to 145 days
Incidence of abnormal laboratory test results	up to 145 days
Incidence of clinically abnormal physical exam	up to 145 days
Incidence of clinically abnormal electrocardiograms	up to 145 days

Secondary Outcome Measures

Name	Time	Method
Change from baseline in concentration of iron laboratory parameter	up to 145 days
Change from baseline in concentration of hematologic laboratory parameters	up to 145 days
Cmax-Maximum drug concentration measured in plasma	up to 145 days
Tmax-Time of maximum drug concentration	up to 145 days
AUC-Area under the drug concentration time curve	up to 145 days
T½ - Elimination half life of the drug	up to 145 days
CL/F-Apparent drug clearance (only for single-dose portion)	up to 57 days
Vz/F; Vss/F -Apparent volume of distribution of the drug (only for single-dose portion)	up to 57 days

Trial Locations

Locations (12)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Rocky Mountain Kidney Care - Lone Tree; 🇺🇸 Lone Tree, Colorado, United States

Accel Research; 🇺🇸 DeLand, Florida, United States

Total Research Group; 🇺🇸 Miami, Florida, United States

Flourish Research; 🇺🇸 Winter Park, Florida, United States

Nephrology and Hypertension Specialists, PC-Dalton; 🇺🇸 Dalton, Georgia, United States

Boise Kidney & Hypertension PLLC; 🇺🇸 Nampa, Idaho, United States

Center for Advanced Kidney Research PLC; 🇺🇸 Saint Clair Shores, Michigan, United States

Centricity Research; 🇺🇸 Columbus, Ohio, United States

Clinical Advancement Center, PLLC; 🇺🇸 San Antonio, Texas, United States

Endeavor Clinical Trials; 🇺🇸 San Antonio, Texas, United States

Washington Nephrology Associates, LLP; 🇺🇸 Alexandria, Virginia, United States