Chronic Kidney DiseasesPhase 1NCT05745883

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

A Phase 1 study testing DISC-0974 in people with Chronic Kidney Diseases and Anemia of Chronic Kidney Disease, run by Disc Medicine, Inc at 13 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Kidney Diseases, Anemia of Chronic Kidney Disease
What is being tested?: DISC-0974
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 55 participants
Where: 13 sitesUnited States
Study dates: 4 Apr 2023to 16 Jan 2026
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

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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)
Confirmed successful vasectomy in conjunction with a barrier method (eg, condom [male or female] or diaphragm)
Able to understand and provide written informed consent
Able to comply with all study procedures

Who cannot join

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

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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
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 known 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 (defined as 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

Trial locations and contacts

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

United States13 sites

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

Other trials in United States

About this study

Official title: 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

Conditions: Chronic Kidney Diseases, Anemia of Chronic Kidney Disease
Being tested: DISC-0974, Placebo
Keywords: Chronic Kidney Disease, Anemia
Medical subject headings: Renal Insufficiency, Chronic, Anemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DISC-0974Drug
DISC-0974 is administered subcutaneously
PlaceboDrug
Placebo is administered subcutaneously

Study groups in NCT05745883
Study group	Role	What they receive
Phase 1b Single Dose	Experimental	Single dose of DISC-0974
Single Dose of Placebo	Placebo comparator	Single dose of placebo Receives: Drug: Placebo
Phase 1b Multiple Doses	Experimental	Multiple doses of DISC-0974 Receives: Drug: DISC-0974
Multiple Doses of Placebo	Placebo comparator	Multiple doses of placebo Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (8)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Apr 202316 Jan 2026

First posted27 Feb 2023
Study start4 Apr 2023
Primary completion9 Oct 2025
Study completion16 Jan 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 55 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05745883
Sponsor's protocol ID: DISC-0974-103
Status last verified: Dec 2025
First submitted: 16 Feb 2023
Last updated: 22 Apr 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT05745883
Acronym / sponsor ID: DISC-0974-103
Conditions: Chronic Kidney Diseases, Anemia of Chronic Kidney Disease
Keywords: Chronic Kidney Disease, Anemia
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 55 participants (actual)
Lead sponsor: Disc Medicine, IncIndustry (pharma, biotech, devices)
Study start: 4 Apr 2023 (actual)
Primary completion: 9 Oct 2025 (actual)
Study completion: 16 Jan 2026 (actual)
First posted: 27 Feb 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Phase 1b Single Dose	Experimental	–Single dose of DISC-0974
Single Dose of Placebo	Placebo comparator	Drug: PlaceboSingle dose of placebo
Phase 1b Multiple Doses	Experimental	Drug: DISC-0974Multiple doses of DISC-0974
Multiple Doses of Placebo	Placebo comparator	Drug: PlaceboMultiple doses of placebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (18 listed)

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%

Key exclusion criteria (23 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DISC-0974DISC-0974 is administered subcutaneously	Drug	Phase 1b Multiple Doses
PlaceboPlacebo is administered subcutaneously	Drug	Multiple Doses of Placebo, Single Dose of Placebo

Primary outcome

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

8 secondary outcomes

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
Individual participant dataSharing planned: No

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End Stage Renal Disease
RecruitingPhase 3
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Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Will Savage, MD PhD study director

Disc Medicine

13 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing DISC-0974 in people with Chronic Kidney Diseases and Anemia of Chronic Kidney Disease, run by Disc Medicine, Inc at 13 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of treatment-emergent adverse events (time frame: up to 145 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05745883.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.