Desidustat in the Treatment of Chemotherapy Induced Anemia (NCT04667533) | Clinical Trial Compass
CompletedPhase 1
Desidustat in the Treatment of Chemotherapy Induced Anemia
India24 participantsStarted 2020-11-11
Plain-language summary
This is a Phase 1, Open-label, Single Dose, Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Desidustat for treatment of anemia in patients receiving chemotherapy.
Who can participate
Age range
19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Diagnosis of non-myeloid malignancy.
. Ability to comprehend and willingness to sign a written ICF for the study.
. Male and Female patients at least 18 years old at the time of signing the ICF.
. Anemia caused by cancer treatment (chemotherapy) defined as Hb ≤11.0 g/dL at screening.
. Subjects with eGFR \>60 mL/min/1.73 meter sequre at screening.
. Weight should be ≥50 kg.
. Willingness to participate after informed consent.
. Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception.
Exclusion criteria
. Known hypersensitivity to Desidustat and excipients in the investigational drug product.
. History or presence of significant alcoholism, smoking or drug of abuse within 30 days at the time of screening.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To evaluate Adverse event of Desidustat following a single oral dose of 100 or 150 or 200 mg in patients with chemotherapy induced anemia.
Timeframe: Change from Baseline to Day 7 and Day 30
. History of RBC transfusion \<4 weeks prior enrollment.
. History or presence of any clinically significant electrocardiogram abnormalities during screening.
. Cardiovascular risks, such as myocardial infarction, stroke, heart failure or thromboembolic event (e.g., deep vein thrombosis (DVT) or pulmonary embolism) within previous 6 months of screening
. Major illness and/or major surgery in the last 3 months.
. Planned elective surgery during the study
. Receiving or has received any investigational drug within the 30 days before receiving Desidustat.