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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 8 weeks
Awards & highlights
Study Summary
This trial tests the safety, effectiveness and how the body processes a drug for people with anemia and kidney disease.
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.Check my eligibility
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.See study design
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 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 8 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of abnormal laboratory test results
Incidence of clinically abnormal electrocardiograms
Incidence of clinically abnormal physical exam
+2 moreSecondary outcome measures
AUC-Area under the drug concentration time curve
CL/F-Apparent drug clearance
Change from baseline in concentration of hematologic laboratory parameters
+5 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Phase 1b Dose EscalationExperimental Treatment1 Intervention
Single ascending dose of DISC-0974
Group II: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
DISC-0974
2021
Completed Phase 1
~50
Find a Location
Who is running the clinical trial?
Disc Medicine, IncLead Sponsor
5 Previous Clinical Trials
437 Total Patients Enrolled
Will Savage, MD PhDStudy DirectorDisc Medicine
4 Previous Clinical Trials
395 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility 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.You have chronic kidney disease, stages 2-5, with a certain level of kidney function measured by a formula.You have had severe kidney problems or needed dialysis in the past 12 weeks, or you are expected to need dialysis in the next 12 weeks.You have an infection that is not getting better with treatment.Your bilirubin levels must be within a normal range when tested before the study.You had cancer in the last 3 years, except for certain types like skin or early stage prostate, breast, or cervical cancer. If you had early stage cancer and finished treatment, you might still be able to participate with approval.You have a positive test for antibodies that attack your own red blood cells, or active severe anemia caused by this type of reaction.You have a history of hereditary hemochromatosis.You have a history of a specific type of blood disorder that causes anemia.You have had your spleen removed in the past.You had a stem cell or organ transplant in the last 10 years.You have received a blood transfusion within the last 3 months.You have previously developed antibodies against a medication.Your blood ferritin level is 100 micrograms per liter or higher when tested at the beginning of the study.Your AST and ALT levels should be less than two times the upper limit of normal at the screening.You have HIV, active Hepatitis B, or active Hepatitis C.Your diabetes is not well controlled, or you started taking insulin for diabetes in the last 3 months.Women with hemoglobin below 10.5 g/dL and men with hemoglobin below 11.0 g/dL are not eligible.You were in the hospital for a heart, kidney, or combined heart-kidney condition within the last 30 days before screening.You have severe heart disease that hasn't been well managed, or a history of very low left ventricular ejection fraction.Your transferrin saturation level is less than or equal to 35%.Your weight is in the range of 18.5 to 45.0 kg/m2 based on your height.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1b Dose Escalation
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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