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DISC-0974 for Anemia in Chronic Kidney Disease
Study Summary
This trial tests the safety, effectiveness and how the body processes a drug for people with anemia and kidney disease.
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- 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.
- Group 1: Phase 1b Dose Escalation
- Group 2: Placebo
- 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.
Frequently Asked Questions
Does this clinical trial accommodate individuals under the age of 65?
"According to the trial's prerequisites, only individuals aged between 18 and 75 are eligible for enrollment."
How many individuals have volunteered to participate in this experiment?
"Affirmative. The latest data available on clinicaltrials.gov reveals that this medical trial is currently looking for 32 volunteers from 5 different locations. The study was initially posted on February 1st 2023 and has since been updated as recently as the 27th of February in the same year."
Are there specific qualifications for participants of this research study?
"The requirements for this trial are anemia of chronic kidney disease and ages between 18 and 75. Approximately 32 participants will be accepted into the study."
Has the FDA sanctioned Phase 1b Dose Escalation?
"Our team at Power assessed the safety of Phase 1b Dose Escalation to be a 1 due to the limited amount of clinical evidence supporting both efficacy and security."
In how many distinct locations is this investigation being conducted?
"A range of research centres are currently running this trial, such as Total Research Group in Miami, Florida Pulmonary Research Institute in Winter Park and Aventiv Research Inc. in Columbus. Additionally there are 5 other locations contributing to the study's success."
Is this trial open to recruitment at the present moment?
"This clinical trial is actively recruiting, as confirmed by information hosted on the clinicaltrials.gov website; it was initially posted in early February of 2023 and has been updated within that same month."
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