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

NCT05745883 | Completed Phase 1 FDA Drug

• 1 other identifier: DISC-0974-103
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 13

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.

Conditions

Chronic Kidney Diseases; Anemia of Chronic Kidney Disease

Keywords

Chronic Kidney Disease; Anemia

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (8)

• 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

Study Arms (4)

Phase 1b Single Dose

EXPERIMENTAL

Single dose of DISC-0974

Single Dose of Placebo

PLACEBO COMPARATOR

Single dose of placebo

Drug: Placebo

Phase 1b Multiple Doses

EXPERIMENTAL

Multiple doses of DISC-0974

Drug: DISC-0974

Multiple Doses of Placebo

PLACEBO COMPARATOR

Multiple doses of placebo

Drug: Placebo

Interventions

DISC-0974 DRUG

DISC-0974 is administered subcutaneously

Phase 1b Multiple Doses

Placebo DRUG

Placebo is administered subcutaneously

Multiple Doses of Placebo; Single Dose of Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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/1.73 m2 using the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula
• Hgb \<11.0 g/dL
• Serum ferritin ≥50 μg/L at screening
• Transferrin saturation ≤35%
• AST and ALT \<2× upper limit of normal (ULN) at screening
• Total and direct bilirubin \<ULN at screening
• 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)
• 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:
• Stable hormonal contraceptive (≥3 months; female partner) in conjunction with a barrier method (eg, condom or diaphragm \[female partner\])
• Intrauterine device in place for at least 3 months (female partner)
• Surgically sterile hysterectomy, bilateral oophorectomy, or bilateral tubal ligation (female partner) in conjunction with a barrier method (eg, condom \[male or female\] or diaphragm)

You may not qualify if:

• 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
• 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
• Acute dialysis or acute kidney injury within 12 weeks prior to screening or expected need to start dialysis within 24 weeks of screening
• Hospitalization for a CV, renal, or cardiorenal condition within 30 days prior to screening
• 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
• 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 B12 or folate deficiency, infection, or bleeding in the 3 months prior to 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 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
• Participation in any other clinical protocol or investigational study that involves administration of experimental therapy and/or therapeutic devices within 30 days of screening

Sponsors & Collaborators

• Disc Medicine, Inc: lead

Study Sites (13)

UCLA Clinical and Translational Research

Los Angeles, California, 90095, United States

Location

US Renal Care Inc.

Lone Tree, Colorado, 80124, United States

Location

Accel Research

DeLand, Florida, 32720, United States

Location

Total Research Group

Miami, Florida, 33126, United States

Location

Flourish Research

Winter Park, Florida, 32789, United States

Location

Nephrology and Hypertension Specialists, PC-Dalton

Dalton, Georgia, 30720, United States

Location

CARE Institute - Boise Kidney

Boise, Idaho, 83706, United States

Location

Center for Advanced Kidney Research PLC

Saint Clair Shores, Michigan, 48081, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Centricity Research

Columbus, Ohio, 43213, United States

Location

Clinical Advancement Center, PLLC

San Antonio, Texas, 78212, United States

Location

Endeavor Clinical Trials

San Antonio, Texas, 78240, United States

Location

Washington Nephrology Associates, LLP

Alexandria, Virginia, 22304, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Anemia

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Will Savage, MD PhD

  Disc Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2023
• First Posted: February 27, 2023
• Study Start: April 4, 2023
• Primary Completion: October 9, 2025
• Study Completion: January 16, 2026
• Last Updated: April 22, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (13)