DISC-0974 for Anemia in Chronic Kidney Disease

Recruiting at13 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Disc Medicine, Inc

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

Disqualifiers: Dialysis, Hemolytic anemia, Hemochromatosis, others

Trial Summary

What is the purpose of this trial?

This trial tests a new drug called DISC-0974 in adults with chronic kidney disease who are not on dialysis and have anemia. It aims to see if the drug is safe and how it behaves in and affects the body.

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.

How is the drug DISC-0974 different from other treatments for anemia in chronic kidney disease?

DISC-0974 is unique because it may offer a new approach to treating anemia in chronic kidney disease, potentially addressing limitations of current treatments like erythropoiesis-stimulating agents (ESAs), which some patients are resistant to. While existing treatments focus on stimulating red blood cell production, DISC-0974 might work through a different mechanism, although specific details about its action are not provided in the available research. ^{1 2 3 4 5}

Research Team

Will Savage, MD PhD

Principal Investigator

Disc Medicine

Eligibility Criteria

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.

Aged ≥18 years of age at the time of signing informed consent

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

Trial Timeline

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

Treatment Details

Interventions

• DISC-0974 (Other)
• Placebo (Other)

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

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

2. Portugal pubmed.ncbi.nlm.nih.gov

[Anemia in Chronic Kidney Disease: The State of the Art]. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Meeting new challenges in the management of anemia of chronic kidney disease through collaborative care with pharmacists. [2009]

4. England 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. [2020]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Real-Life Anemia Management Among Patients with Non-Dialysis-Dependent Chronic Kidney Disease in Three European Countries. [2023]