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This is a phase III, multicenter, multi-country, open-label, randomized, active-controlled clinical trial to evaluate the efficacy and safety of Desidustat versus Darbepoetin for the treatment of anemia in patients with CKD who are not on dialysis. The study will be conducted over a period of up to 30 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Darbepoetin Alfa Injection | Experimental | Randomly assigned to receive Darbepoetin in a 1:1 ratio for 24 weeks. |
|
| Desidustat oral tablet | Active Comparator | Randomly assigned to receive Desidustat 100 mg in a 1:1 ratio for 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Desidustat Oral Tablet | Drug | Desidustat tablet |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin level | Change in Hb levels from baseline | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin Response | No. of subjects with Hb response | 24 weeks |
| Hemoglobin target range | Time to achieve target range Hb level | 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| DrDeven Parmar, MD | Zydus Lifesciences Limited | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sunrise Hospital | Vijayawada | Andhra Pradesh | 520002 | India | ||
| HCG Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36005278 | Derived | 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. |
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| Darbepoetin Alfa |
| Drug |
Darbepoetin injection |
|
| Ahmedabad |
| Gujarat |
| 380006 |
| India |
| Sangini Hospital | Ahmedabad | Gujarat | 380015 | India |
| GSC Medical College and Research Centre | Ahmedabad | Gujarat | 380025 | India |
| Thakershey Charitable trust Hospital | Ahmedabad | Gujarat | India |
| BAPS Pramukh Swami Hospital | Surat | Gujarat | 395009 | India |
| Sterling Hospital | Vadodara | Gujarat | 390007 | India |
| Dhiraj General Hospital | Vadodara | Gujarat | 391760 | India |
| Sapthagiri Institute of Medical Sciences | Bangalore | Karnataka | 560090 | India |
| Kasturba Medical College | Mangalore | Karnataka | 575001 | India |
| Amrita Institute of Medical Science | Kochi | Kerala | 682041 | India |
| Government Medical College | Kozhikode | Kerala | 673008 | India |
| Mahatma Gandhi Mission Medical College & Hospital | Aurangabad | Maharashtra | 431003 | India |
| Nav Sanjeevani Hospital (Sankalp Speciality Healthcare Pvt. Ltd) | Nashik | Maharashtra | 422002 | India |
| Noble Hospital | Pune | Maharashtra | 411013 | India |
| Bhaktivedanta Hospital and Research Institute | Thane | Maharashtra | 401107 | India |
| Asian Institute Of Medical Sciences (AIMS) Hospital | Thane | Maharashtra | 421203 | India |
| Max Super Specialty Hospital | New Delhi | National Capital Territory of Delhi | 110017 | India |
| Fortis Hospital | Delhi | New Delhi | 110070 | India |
| Apollo Hospital | Bhubaneswar | Odisha | 751005 | India |
| Sardar Patel Medical College | Bikaner | Rajasthan | 334003 | India |
| Sawai Man Singh (SMS) Medical College and Hospital | Jaipur | Rajasthan | 302004 | India |
| Eternal Hospital | Jaipur | Rajasthan | 302017 | India |
| Rukmani Birla Hospital | Jaipur | Rajasthan | 302018 | India |
| Osmania General Hospital | Hyderabad | Telangana | 500012 | India |
| Apollo Hospital | Hyderabad | Telangana | 500058 | India |
| Nizams Institute of Medical Sciences | Hyderabad | Telangana | 500082 | India |
| Nizams Institute of Medical Sciences | Hyderabad | Telangana | 524001 | India |
| Heritage Hospitals Limited | Varanasi | Uttar Pradesh | 221311 | India |
| Shri Mahant Indiresh Hospital | Dehradun | Uttarakhand | 248001 | India |
| Medica Superspecialty Hospital | Kolkata | West Bangal | 700099 | India |
| Peerless Hospital | Kolkata | West Bengal | 700094 | India |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D000740 | Anemia |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C000623340 | desidustat |
| D000068256 | Darbepoetin alfa |
| ID | Term |
|---|---|
| D004921 | Erythropoietin |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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