DISC-0974 for Anemia in Chronic Kidney Disease

Not currently recruiting at 13 trial locations

Overseen By Disc Medicine Clinical Trials

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Disc Medicine, Inc

Must not be taking: Oral iron, ESAs, IV iron

Disqualifiers: Dialysis, Hemolytic anemia, Hemochromatosis, others

Compensation: Varies

Number of Visits: Unknown

Duration: 4-8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effectiveness of a new treatment called DISC-0974 for anemia in people with chronic kidney disease who are not on dialysis. The study will examine how the body processes the treatment and its impact on anemia symptoms. Participants will receive either a single or multiple doses of DISC-0974 or a placebo (a substance with no active medication) to compare results. Individuals with chronic kidney disease and anemia, with hemoglobin levels lower than 11.0 g/dL, might be suitable candidates for this trial. As a Phase 1 trial, this research focuses on understanding how the new treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

Will I have to stop taking my current medications?

The trial requires a 2-day break from oral iron supplements and a 30-day break from certain anemia treatments like blood transfusions, ESAs, or IV iron before starting. Other medications are not specifically mentioned, so it's best to discuss with the study team.

Is there any evidence suggesting that DISC-0974 is likely to be safe for humans?

Research has shown that DISC-0974 is safe and well-tolerated. Patients have handled both single and multiple doses without major issues, and no serious safety problems have been reported. In earlier tests with healthy volunteers, DISC-0974 successfully lowered certain proteins in the blood, indicating it is working as expected. This boosts confidence in its safety. Although this treatment is still in the early stages, the results are promising for those considering joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for anemia?

DISC-0974 is unique because it targets anemia in chronic kidney disease differently than current treatments. Most standard treatments for this condition, like erythropoiesis-stimulating agents (ESAs), work by stimulating red blood cell production. However, DISC-0974 operates by inhibiting a protein called hemojuvelin, which helps regulate iron metabolism. This novel mechanism can potentially increase the availability of iron for red blood cell production without the risks associated with ESAs. Researchers are excited about DISC-0974 because it offers a promising alternative that could improve patient outcomes with fewer side effects.

What evidence suggests that DISC-0974 might be an effective treatment for anemia in chronic kidney disease?

Research shows that DISC-0974, which participants in this trial may receive, may help treat anemia in people with chronic kidney disease. Early studies found that DISC-0974 is generally safe and well-tolerated at different doses. Importantly, DISC-0974 lowers hepcidin, a protein that can worsen anemia. This decrease in hepcidin led to positive changes in patients' blood. These early results suggest that DISC-0974 could effectively improve anemia in this group of patients. ^{1 5 6 7 8}

Who Is on the Research Team?

Will Savage, MD PhD

Principal Investigator

Disc Medicine

Are You a Good Fit for This Trial?

Adults with non-dialysis chronic kidney disease stages 2-5 and anemia can join this trial. They must have specific levels of hemoglobin, bilirubin, ferritin, and transferrin saturation. BMI should be between 18.5 to 45 kg/m2. People with recent heart attacks, strokes, certain infections or surgeries, or those on recent iron supplements or anemia treatments cannot participate.

Inclusion Criteria

You have chronic kidney disease, stages 2-5, with a certain level of kidney function measured by a formula.

Your bilirubin levels must be within a normal range when tested before the study.

Your blood ferritin level is 100 micrograms per liter or higher when tested at the beginning of the study.

Exclusion Criteria

You have had anemia caused by low vitamin B12 or folate, infection, or bleeding in the 3 months before the screening.

You had a stroke, heart attack, blood clot, or lung blood clot in the past 6 months.

Participation in any other clinical protocol or investigational trial that involves administration of experimental therapy and/or therapeutic devices within 30 days of Screening

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive single or multiple doses of DISC-0974 or placebo

4-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• DISC-0974
• Placebo

Trial Overview The study is testing DISC-0974's safety and effects in adults with chronic kidney disease who are not on dialysis but have anemia. Participants will either receive DISC-0974 or a placebo to compare outcomes.

How Is the Trial Designed?

Group I: Phase 1b Single Dose Experimental Treatment 1 Intervention

Single dose of DISC-0974

Group II: Phase 1b Multiple Doses Experimental Treatment 1 Intervention

Multiple doses of DISC-0974

Group III: Single Dose of Placebo Placebo Group 1 Intervention

Single dose of placebo

Group IV: Multiple Doses of Placebo Placebo Group 1 Intervention

Multiple doses of placebo

Who Is Running the Clinical Trial?

Disc Medicine, Inc

Lead Sponsor

Trials

6

Recruited

580+

Published Research Related to This Trial

In a study of 53 patients with chronic kidney disease (CKD) and primary ESA-resistant anemia, serum alkaline phosphatase levels were found to be weakly associated with the severity of erythropoiesis stimulating agent (ESA) resistance, suggesting a potential biomarker for assessing ESA resistance.

No significant differences were found in common factors like age, gender, or iron levels among different levels of ESA resistance, indicating that serum alkaline phosphatase may be a unique determinant in understanding ESA resistance in CKD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between serum alkaline phosphatase and primary resistance to erythropoiesis stimulating agents in chronic kidney disease: a secondary analysis of the HERO trial. Badve, SV., Zhang, L., Coombes, JS., et al.[2020]

Chronic kidney disease (CKD) often leads to anemia, which significantly affects patients' quality of life and poses a financial burden on the healthcare system; effective management is crucial.

Collaboration with clinical pharmacists is essential for optimizing treatment strategies for CKD-associated anemia, ensuring patient-centered care, and improving the selection and monitoring of erythropoiesis-stimulating agents (ESAs).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meeting new challenges in the management of anemia of chronic kidney disease through collaborative care with pharmacists. Bacchus, S., O'Mara, N., Manley, H., et al.[2009]

In a study of 848 patients with non-dialysis-dependent chronic kidney disease (CKD) receiving erythropoiesis-stimulating agent (ESA) therapy, it was found that while ESA initiation followed KDIGO guidelines, monitoring of hemoglobin and iron levels after treatment was inadequate.

Approximately 40% of patients did not receive iron therapy before starting ESA, and while hemoglobin levels improved to target ranges within 3-6 months, there was infrequent monitoring of key blood parameters, which could impact treatment efficacy and patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-Life Anemia Management Among Patients with Non-Dialysis-Dependent Chronic Kidney Disease in Three European Countries. Fliser, D., Mata Lorenzo, M., Houghton, K., et al.[2023]

Anemia is a common and serious complication of chronic kidney disease, affecting both the quality of life and prognosis of patients, especially as the population ages.

Recent advancements in treatment options, including recombinant erythropoietin, parenteral iron, and new hypoxia-inducible factor inhibitors, have improved the management of anemia in chronic kidney disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Anemia in Chronic Kidney Disease: The State of the Art]. Farinha, A., Robalo Nunes, A., Mairos, J., et al.[2023]

Anemia is a common and serious complication in chronic kidney disease (CKD) patients, affecting over 40% of this population, and is linked to increased risks of cardiovascular disease and higher hospitalization and mortality rates.

Erythropoiesis-stimulating proteins (ESPs) like epoetin alfa and darbepoetin alfa are effective treatments for anemia in CKD, but many patients still present with low hemoglobin levels when starting dialysis, highlighting the need for better recognition and management of anemia in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practical approach to the diagnosis and treatment of anemia associated with CKD in elderly. Agarwal, AK.[2015]

Citations

1. ir.discmedicine.com ir.discmedicine.com/news-releases/news-release-details/disc-medicine-present-data-phase-1b-trial-disc-0974-patients

Disc Medicine to Present Data from Phase 1b Trial of ... This study was designed to assess the safety, tolerability and pharmacokinetics of single ascending and multiple doses of DISC-0974, as well as ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05745883

NCT05745883 | Study of DISC-0974 to Assess the Safety, ... This Phase 1b study of DISC-0974 will assess the safety, tolerability, pharmacokinetics (PK) and Pharmacodynamics (PD) of DISC-0974 in adult participants.

3. coursesv4bbs.blob.core.windows.net coursesv4bbs.blob.core.windows.net/nkf/content-item/0ac9bb11-77a6-4ee5-80dd-4575351e0a97/nkf-2025_0974-ckd-final_03-26-2025.pdf

CONCLUSIONS INTRODUCTION RESULTS METHODS AIM DISC-0974 demonstrated acceptable safety and tolerability at all evaluated dose levels. • DISC-0974 dosing resulted in decreased.

4. ashpublications.org ashpublications.org/blood/article/144/Supplement%201/657/530242/A-Phase-1b-Study-of-DISC-0974-an-Anti-Hemojuvelin

A Phase 1b Study of DISC-0974, an Anti-Hemojuvelin ... Hematologic responses were achieved in nTD and TD participants, regardless of concomitant JAK inhibitor use. Sustained hepcidin reduction with ...

5. docwirenews.com docwirenews.com/post/fda-gives-fast-track-designation-to-anemia-treatment-for-ndd-ckd-patients

FDA Gives Fast Track Designation to Anemia Treatment for ... The FDA has granted Fast Track designation DISC-0974 for the treatment of anemia in patients with nondialysis-dependent chronic kidney ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05745883

NCT05745883 | Study of DISC-0974 to Assess the Safety, ... This Phase 1b study of DISC-0974 will assess the safety, tolerability, pharmacokinetics (PK) and Pharmacodynamics (PD) of DISC-0974 in adult participants with ...

7. discmedicine.com discmedicine.com/wp-content/uploads/2024/10/DISC-0974_Poster_ASN2024.pdf

DISC-0974 DISC-0974 demonstrated acceptable safety and tolerability at all ... ANTIBODY, IN PATIENTS WITH NON-DIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE AND ANEMIA.

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0006497123118374

A Phase 1b Double-Blind, Placebo-Controlled Study of ... In a healthy volunteer study, DISC-0974 demonstrated dose-dependent reductions in serum hepcidin, increases in serum iron with doses up to 56 mg ...