What side effects are associated with this type of intervention?

Common treatments for anemia in Chronic Kidney Disease (CKD) include erythropoiesis-stimulating agents (ESAs) and iron chelation therapy. ESAs can increase the risk of thrombosis, hypertension, and cardiovascular events. Iron chelation therapy, used to manage iron overload from chronic transfusions, can cause gastrointestinal symptoms and impaired kidney function. Monitoring and managing these side effects are crucial for patient safety.

What prior FDA approvals exist?

The FDA has approved several treatments for anemia in Chronic Kidney Disease (CKD) that focus on erythropoiesis and iron metabolism. Erythropoiesis-stimulating agents (ESAs) such as epoetin alfa and darbepoetin alfa are commonly used to stimulate red blood cell production. Additionally, iron supplements, both oral and intravenous, are used to manage iron deficiency, which is often associated with anemia in CKD. These treatments aim to improve hemoglobin levels and reduce the need for blood transfusions in CKD patients.

What other types of research exist?

Promising alternatives to DISC-0974 for treating anemia in CKD patients include roxadustat, which has shown efficacy in increasing hemoglobin levels in both nondialysis-dependent and dialysis-dependent CKD patients. Additionally, erythropoiesis-stimulating agents (ESAs) like epoetin alfa and novel agents such as luspatercept, which targets ineffective erythropoiesis, are also potential options.

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DISC-0974 for Anemia in Chronic Kidney Disease

Phase 1

Recruiting

Research Sponsored by Disc Medicine, Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include reactions at the injection site, changes in blood pressure or heart rate, fatigue, headache, nausea and potential allergic reactions among others that will be closely monitored throughout the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Phase 1b Single DoseExperimental Treatment1 Intervention

Single dose of DISC-0974

Group II: Phase 1b Multiple DosesExperimental Treatment1 Intervention

Multiple doses of DISC-0974

Group III: Single Dose of PlaceboPlacebo Group1 Intervention

Single dose of placebo

Group IV: Multiple Doses of PlaceboPlacebo Group1 Intervention

Multiple doses of placebo

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

DISC-0974

2021

Completed Phase 1

~50

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Chronic Kidney Disease (CKD) related anemia include erythropoiesis-stimulating agents (ESAs) and iron supplementation. ESAs stimulate the bone marrow to increase red blood cell production, counteracting the reduced erythropoietin levels due to kidney damage. Iron supplements, either oral or intravenous, ensure adequate iron availability for hemoglobin synthesis. These treatments are vital for managing anemia in CKD patients, improving their quality of life and reducing the risk of cardiovascular complications. The trial DISC-0974 likely explores new mechanisms in erythropoiesis or iron metabolism, potentially offering enhanced efficacy or safety profiles.