Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
588 participants
INTERVENTIONAL
2019-07-20
2021-08-25
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Darbepoetin Alfa Injection
Randomly assigned to receive Darbepoetin in a 1:1 ratio for 24 weeks.
Darbepoetin Alfa
Darbepoetin injection
Desidustat oral tablet
Randomly assigned to receive Desidustat 100 mg in a 1:1 ratio for 24 weeks.
Desidustat Oral Tablet
Desidustat tablet
Interventions
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Desidustat Oral Tablet
Desidustat tablet
Darbepoetin Alfa
Darbepoetin injection
Eligibility Criteria
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Inclusion Criteria
2. Ability to understand and give informed consent for participation.
3. Male or female patients diagnosed with CKD (stage III to V, not receiving dialysis) defined by estimated glomerular filtration rate (eGFR) using the CKD Epidemiology Collaboration (CKD-EPI) formula.
4. Male or female, 18 to 80 years of age.
5. Body weight \> 40 kg.
6. Subjects not on dialysis and not expected to start dialysis during the study period.
7. Patients must not be treated with erythropoiesis-stimulating agent (ESA) therapy within 6 weeks prior to enrollment.
8. Estimated GFR ≥10 mL/min/1.73 m2.
9. Serum ferritin ≥100 ng/mL and/or Transferrin Saturation \>20%.
10. No iron, folate or Vitamin B12 deficiency.
11. Females of childbearing potential, must agree to use one of the approved contraception methods, from screening until completion of the follow-up visit.
Exclusion Criteria
2. Intravenous iron within 14 days prior to enrollment.
3. Prior exposure of rhEPO analogues less than 04 weeks.
4. Red blood cell transfusion within 8 weeks prior to enrollment.
5. History of previous or concurrent cancer.
6. Serologic status reflecting active hepatitis B or C infection or Human immunodeficiency virus (HIV) infection.
7. Active infection prior to enrollment.
8. History of renal transplant.
9. Major surgery within 90 days of the first day of study drug dosing, and minor surgery within 30 days of the first day of study drug dosing.
10. Unable to swallow tablets or disease significantly affecting gastrointestinal function and/or inhibiting small intestine absorption such as; mal-absorption syndrome, resection of the small bowel or poorly controlled inflammatory bowel disease affecting the small intestine.
11. History of uncontrolled autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura (ITP) or thalassemia.
12. Presence or a history of bleeding disorders or clinical conditions (e.g. gastrointestinal \[GI\] bleeding or constitutional disorders) that may increase risk of life-threatening bleeding.
13. History of stroke or intracranial hemorrhage within 6 months prior to enrollment.
14. History of severe allergic or hypersensitivity to investigational products and its excipients.
15. Requires or is receiving anticoagulation with warfarin or equivalent vitamin K antagonists or other medications within 28 days of the first dose of study drug that in the investigator's opinion, could compromise patient safety.
16. Pregnant and breastfeeding women.
17. Current life-threatening illness, medical condition or organ system dysfunction which, in the Investigator's opinion, could compromise the patient's safety.
18. Other laboratory abnormalities that, in the opinion of the investigator, would compromise the patient's safety or interfere with data interpretation.
19. Presence of other systemic disorders or diseases (e.g., respiratory, gastrointestinal, endocrine, immunological, dermatological, neurological, psychiatric disease or any other body system involvement) which, in the Investigator's opinion, could compromise the patient's safety.
20. History of significant alcoholism or drug abuse within the past 1 year. History or presence of significant smoking (more than 10 cigarettes per day) or consumption of tobacco/nicotine products (more than 10 times per day).
21. History of difficulty with donating blood.
22. History or presence of any clinically significant ECG abnormalities during screening.
23. Participants who have participated in any drug research study other than the present trial within past 3 months.
24. Participants who have donated one unit (350 ml) of blood in the past 3 months or history of whole blood transfusion in last 120 days prior to enrollment.
25. History of chronic inflammatory disease (RA, Celiac disease, UC, Crohns disease, Systemic Lupus Erythematosus \[SLE\]).
26. In case of Diabetes mellitus patients, glycosylated haemoglobin (HbA1c) \>9 %.
18 Years
80 Years
ALL
No
Sponsors
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Zydus Lifesciences Limited
INDUSTRY
Responsible Party
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Principal Investigators
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DrDeven Parmar, MD
Role: STUDY_DIRECTOR
Zydus Lifesciences Limited
Locations
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Sunrise Hospital
Vijayawada, Andhra Pradesh, India
HCG Hospital
Ahmedabad, Gujarat, India
Sangini Hospital
Ahmedabad, Gujarat, India
GSC Medical College and Research Centre
Ahmedabad, Gujarat, India
Thakershey Charitable trust Hospital
Ahmedabad, Gujarat, India
BAPS Pramukh Swami Hospital
Surat, Gujarat, India
Sterling Hospital
Vadodara, Gujarat, India
Dhiraj General Hospital
Vadodara, Gujarat, India
Sapthagiri Institute of Medical Sciences
Bangalore, Karnataka, India
Kasturba Medical College
Mangalore, Karnataka, India
Amrita Institute of Medical Science
Kochi, Kerala, India
Government Medical College
Kozhikode, Kerala, India
Mahatma Gandhi Mission Medical College & Hospital
Aurangabad, Maharashtra, India
Nav Sanjeevani Hospital (Sankalp Speciality Healthcare Pvt. Ltd)
Nashik, Maharashtra, India
Noble Hospital
Pune, Maharashtra, India
Bhaktivedanta Hospital and Research Institute
Thāne, Maharashtra, India
Asian Institute Of Medical Sciences (AIMS) Hospital
Thāne, Maharashtra, India
Max Super Specialty Hospital
New Delhi, National Capital Territory of Delhi, India
Fortis Hospital
Delhi, New Delhi, India
Apollo Hospital
Bhubaneswar, Odisha, India
Sardar Patel Medical College
Bikaner, Rajasthan, India
Sawai Man Singh (SMS) Medical College and Hospital
Jaipur, Rajasthan, India
Eternal Hospital
Jaipur, Rajasthan, India
Rukmani Birla Hospital
Jaipur, Rajasthan, India
Osmania General Hospital
Hyderabad, Telangana, India
Apollo Hospital
Hyderabad, Telangana, India
Nizams Institute of Medical Sciences
Hyderabad, Telangana, India
Nizams Institute of Medical Sciences
Hyderabad, Telangana, India
Heritage Hospitals Limited
Varanasi, Uttar Pradesh, India
Shri Mahant Indiresh Hospital
Dehradun, Uttarakhand, India
Medica Superspecialty Hospital
Kolkata, West Bangal, India
Peerless Hospital
Kolkata, West Bengal, India
Countries
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References
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Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.
Other Identifiers
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DESI.18.001
Identifier Type: -
Identifier Source: org_study_id