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Clinical Trial Details

Trial ID: L0555
Source ID: NCT04012957
Associated Drug: Desidustat Oral Tablet
Title: Desidustat in the Treatment of Anemia in CKD
Acronym: DREAM-ND
Status: COMPLETED
Study Results: NO
Results:
Conditions: Chronic Kidney Disease Stage 3|Anemia|Chronic Kidney Disease Stage 4|Chronic Kidney Disease Stage 5
Interventions: DRUG: Desidustat Oral Tablet|DRUG: Darbepoetin Alfa
Outcome Measures: Primary: Hemoglobin level, Change in Hb levels from baseline, 24 weeks | Secondary: Hemoglobin Response, No. of subjects with Hb response, 24 weeks|Hemoglobin target range, Time to achieve target range Hb level, 24 weeks
Sponsor/Collaborators: Sponsor: Zydus Lifesciences Limited
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 588
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2019-07-20
Completion Date: 2021-08-25
Results First Posted:
Last Update Posted: 2021-11-24
Locations: Sunrise Hospital, Vijayawada, Andhra Pradesh, 520002, India|Max Super Specialty Hospital, New Delhi, Delhi, 110017, India|Thakershey Charitable trust Hospital, Ahmadabad, Gujarat, India|HCG Hospital, Ahmedabad, Gujarat, 380006, India|Sangini Hospital, Ahmedabad, Gujarat, 380015, India|GSC Medical College and Research Centre, Ahmedabad, Gujarat, 380025, India|BAPS Pramukh Swami Hospital, Sūrat, 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, Thāne, Maharashtra, 401107, India|Asian Institute Of Medical Sciences (AIMS) Hospital, Thāne, Maharashtra, 421203, India|Fortis Hospital, Delhi, New Delhi, 110070, India|Apollo Hospital, Bhubaneswar, Orissa, 751005, India|Sardar Patel Medical College, Bīkaner, 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, Uttaranchal, 248001, India|Medica Superspecialty Hospital, Kolkata, West Bangal, 700099, India|Peerless Hospital, Kolkata, WEST Bengal, 700094, India
URL: https://clinicaltrials.gov/show/NCT04012957