Actively Recruiting
A Phase 4, 52 Week, Single Arm, Multicentre Post Marketing Surveillance to Evaluate the Safety of Desidustat for the Treatment of Anemia in Subjects With Chronic Kidney Disease (CKD)
Led by Zydus Lifesciences Limited · Updated on 2025-01-22
1004
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the long-term safety of Desidustat for treating anemia in people with chronic kidney disease (CKD). This Phase 4, single-arm study includes both participants who are dependent on dialysis and those who are not, aiming to gather real-world evidence on the treatment's safety over one year. Participants will take oral Desidustat tablets from the start of the study up to 52 weeks. The study group includes 1004 individuals, split evenly between those on dialysis and those who are not. The treatment is monitored closely to assess any adverse events and serious adverse events throughout the duration. During the year-long study, participants will undergo regular assessments including blood tests to monitor hemoglobin levels, lipid profiles, VEGF, and serum Hepcidin. Researchers will track side effects and serious adverse events to evaluate safety. The study ends at week 52, after which participants' treatment and health status will be reviewed.
CONDITIONS
Brief 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 to 85 years of age
- Clinical diagnosis of anemia due to chronic kidney disease with baseline hemoglobin 7.0-11.0 g/dL
- Ability to understand and provide informed consent
- No significant folate or Vitamin B12 deficiency
- Females of childbearing potential must use approved contraception from screening until end of study
- For hemodialysis-dependent subjects: receiving hemodialysis at least twice weekly for 12 weeks and having appropriate vascular access
- Subjects not treated with erythropoietin analogue for at least 4 weeks and Mircera for at least 8 weeks prior to screening or on stable ESA dose for 4 weeks prior to enrollment
You will not qualify if you...
- Received red blood cell transfusion within 8 weeks prior to enrollment
- Pre-dialysis subjects exposed to ESA agents within 6 weeks prior to enrollment
- Diabetes with HbA1c > 9%
- Uncontrolled hypertension with BP >160/100 mm Hg
- History of cancer, renal transplant, severe allergies, or chronic inflammatory diseases
- Active Hepatitis B, C, or HIV infection
- History of uncontrolled autoimmune hemolytic anemia, ITP, thalassemia, bleeding disorders, or use of anticoagulants that may risk bleeding
- Major surgery within 90 days or minor surgery within 30 days prior to enrollment
- Unable to swallow tablets or significant gastrointestinal dysfunction
- Recent myocardial infarction, stroke, or intracranial hemorrhage within 6 months
- Active significant cardiovascular disease (NYHA class 3 or 4)
- Life-threatening illnesses or medical conditions compromising safety
- History of significant alcoholism, drug abuse, or heavy smoking
- History of blood donation difficulties
- Clinically significant ECG abnormalities
- Participation in other drug studies within 3 months
- Female volunteers pregnant, breastfeeding, or with recent pregnancy or lactation within 3 months
- Abnormal lab values including low WBC or platelet counts, high bilirubin, or elevated liver enzymes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 52 weeks
Participants receive oral Desidustat from baseline to Week 52 to treat anemia associated with chronic kidney disease.
Regular visits throughout 52 weeks for treatment monitoring
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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