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

A Phase 1b Multicenter, Randomized, Double-Blind, Placebo-Controlled Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DISC-0974 in Participants With Non-Dialysis Dependent Chronic Kidney Disease and Anemia

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.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Diseases; Anemia of Chronic Kidney Disease
• Intervention / Treatment: Drug: DISC-0974; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • UCLA Clinical and Translational Research
  • Colorado
    • Lone Tree, Colorado, United States, 80124
      • US Renal Care Inc.
  • Florida
    • DeLand, Florida, United States, 32720
      • Accel Research
    • Miami, Florida, United States, 33126
      • Total Research Group
    • Winter Park, Florida, United States, 32789
      • Flourish Research
  • Georgia
    • Dalton, Georgia, United States, 30720
      • Nephrology and Hypertension Specialists, PC-Dalton
  • Idaho
    • Boise, Idaho, United States, 83706
      • CARE Institute - Boise Kidney
  • Michigan
    • Saint Clair Shores, Michigan, United States, 48081
      • Center for Advanced Kidney Research PLC
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Ohio
    • Columbus, Ohio, United States, 43213
      • Centricity Research
  • Texas
    • San Antonio, Texas, United States, 78212
      • Clinical Advancement Center, PLLC
    • San Antonio, Texas, United States, 78240
      • Endeavor Clinical Trials
  • Virginia
    • Alexandria, Virginia, United States, 22304
      • Washington Nephrology Associates, LLP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 <90 mL/min/1.73 m2 using the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula
3. Hgb <11.0 g/dL
4. Serum ferritin ≥50 μg/L at screening
5. Transferrin saturation ≤35%
6. AST and ALT <2× upper limit of normal (ULN) at screening
7. Total and direct bilirubin <ULN at screening

8. If female, then EITHER postmenopausal, defined as at least 12 months of natural, spontaneous amenorrhea and serum follicle-stimulating hormone >40 mIU/mL at screening, or at least 6 weeks following surgical menopause (bilateral oophorectomy or hysterectomy); OR agreeable to use of highly effective contraception (listed below) on Day 1 (or earlier) for at least 8 weeks after the last dose of study drug:

   • Stable hormonal contraceptive (≥3 months) in conjunction with a barrier method (eg, condom [male or female] or diaphragm)
   • Intrauterine device in place for at least 3 months
   • Tubal ligation or single male partner with vasectomy in conjunction with a barrier method (eg, condom [male or female] or diaphragm)

9. If male with female sexual partner(s) of childbearing potential, agrees to use one of the following acceptable methods of contraception during the study and for at least 8 weeks after the last study drug dose:

   1. Stable hormonal contraceptive (≥3 months; female partner) in conjunction with a barrier method (eg, condom or diaphragm [female partner])
   2. Intrauterine device in place for at least 3 months (female partner)
   3. Surgically sterile hysterectomy, bilateral oophorectomy, or bilateral tubal ligation (female partner) in conjunction with a barrier method (eg, condom [male or female] or diaphragm)
   4. Confirmed successful vasectomy in conjunction with a barrier method (eg, condom [male or female] or diaphragm)
10. Able to understand and provide written informed consent
11. Able to comply with all study procedures

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phase 1b Single Dose; Single dose of DISC-0974	Drug: DISC-0974; DISC-0974 is administered subcutaneously
Placebo Comparator: Single Dose of Placebo; Single dose of placebo	Drug: Placebo; Placebo is administered subcutaneously
Experimental: Phase 1b Multiple Doses; Multiple doses of DISC-0974	Drug: DISC-0974; DISC-0974 is administered subcutaneously
Placebo Comparator: Multiple Doses of Placebo; Multiple doses of placebo	Drug: Placebo; Placebo is administered subcutaneously

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Disc Medicine, Inc
• Investigators: Study Director: Will Savage, MD PhD, Disc Medicine

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2023
• Primary Completion (Actual): October 9, 2025
• Study Completion (Actual): January 16, 2026

Study Registration Dates

• First Submitted: February 16, 2023
• First Submitted That Met QC Criteria: February 16, 2023
• First Posted (Actual): February 27, 2023

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Anemia; Chronic Kidney Disease
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Hematologic Diseases; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Renal Insufficiency, Chronic; Anemia
• Other Study ID Numbers: DISC-0974-103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No