Actively Recruiting
Post-Marketing Safety Study of Desidustat for Anemia in Chronic Kidney Disease A 52-Week, Single-Arm, Multicenter Study Evaluating Long-Term Safety
Led by Zydus Lifesciences Limited · Updated on 2025-01-22
1004
Participants Needed
1
Research Sites
136 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the long-term safety of Desidustat, an oral medication, for treating anemia in adults with chronic kidney disease (CKD). This Phase 4 study includes both dialysis-dependent and dialysis-independent patients, aiming to gather real-world safety data over a one-year period. A total of 1004 participants are planned, equally divided between those on dialysis and those not requiring dialysis. Participants will receive Desidustat tablets and be monitored for 52 weeks in this single-arm, multicenter trial. The study includes a comprehensive assessment of treatment-emergent adverse events and serious adverse events throughout the treatment period. The research aims to provide extended safety information after Desidustat's market approval. During the study, participants will undergo regular evaluations including clinical assessments, laboratory tests, and safety monitoring. Researchers will track changes in hemoglobin levels and watch for any side effects or complications. The study also involves periodic follow-up visits to ensure ongoing safety and to measure the overall impact of Desidustat treatment over the full year.
CONDITIONS
Official Title
A Post Marketing Surveillance to Evaluate the Safety of Desidustat for the Treatment of Anemia in Subjects With Chronic Kidney Disease (CKD).(Real World Evidence Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, 18 years of age or older
- Diagnosed with anemia due to chronic kidney disease with hemoglobin levels between 7.0 and 11.0 g/dL
- Able to understand and provide informed consent
- No significant folate or Vitamin B12 deficiency
- Females of childbearing potential agree to use approved contraception from screening until the end of the study
- For dialysis-dependent subjects: receiving hemodialysis sessions at least twice a week for 12 weeks before screening and have vascular access (arteriovenous fistula, graft, or catheter)
- Subjects not treated with erythropoietin analogues for specified durations or on stable ESA therapy doses for 4 weeks prior to enrollment
You will not qualify if you...
- Received red blood cell transfusion within 8 weeks before enrollment
- Pre-dialysis subjects exposed to ESA agents within 6 weeks before enrollment
- Diabetes patients with HbA1c greater than 9%
- Hypertensive patients with systolic BP over 160 mm Hg or diastolic BP over 100 mm Hg or uncontrolled blood pressure
- History of cancer, renal transplant, severe allergy to investigational products, or chronic inflammatory diseases like rheumatoid arthritis, celiac disease, ulcerative colitis, Crohn's disease, or systemic lupus erythematosus
- Active Hepatitis B or C, or HIV infection
- History of uncontrolled autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura, thalassemia, bleeding disorders, or conditions increasing bleeding risk, or recent use of anticoagulants compromising safety
- Major surgery within 90 days or minor surgery within 30 days before enrollment
- Unable to swallow tablets or having gastrointestinal conditions affecting absorption
- History of myocardial infarction, stroke, or intracranial hemorrhage within 6 months before enrollment
- Active significant cardiovascular disease including uncontrolled arrhythmia or severe heart failure
- Life-threatening illnesses or medical conditions compromising safety
- Significant alcoholism or drug abuse in the past year, heavy smoking or tobacco use
- History of difficulty donating blood
- Clinically significant ECG abnormalities at screening
- Participation in other drug studies within the past 3 months
- Females with recent pregnancy or lactation, inadequate contraception, hormone therapy, positive pregnancy test, or currently pregnant or breastfeeding
- Abnormal baseline laboratory values including low white blood cell or platelet counts, elevated bilirubin, or high liver enzymes
AI-Screening
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Trial Site Locations
Total: 1 location
1
Indira Gandhi Institute of Medical Sciences
Sheikhpura, Bihar, India, 800014
Actively Recruiting
Research Team
D
Dr Kevin Kansagra, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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