Clinical Trial Details
| Trial ID: | L1216 |
| Source ID: | NCT04215120 |
| Associated Drug: | Desidustat Oral Tablet |
| Title: | Desidustat in the Treatment of Anemia in CKD on Dialysis Patients |
| Acronym: | DREAM-D |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Chronic Kidney Disease Stage 5 on Dialysis |
| Interventions: | DRUG: Desidustat Oral Tablet|DRUG: Epoetin 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: | 392 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2020-01-04 |
| Completion Date: | 2021-09-02 |
| Results First Posted: | |
| Last Update Posted: | 2021-11-24 |
| Locations: | Karnavati Hospital Pvt.Ltd, Ahmedabad, Gujarat, 380006, India|Shalby Hospital,, Ahmedabad, Gujarat, 380015, India|DHS Multispecialty Hospital, Ahmedabad, Gujarat, 380054, India|Chopda Medicare & Research Centre Pvt. Ltd, Nashik, Maharashtra, 422005, India|Aditya Birla Memorial Hospital, Pune, Maharashtra, 411033, India|Eternal Hospital, Jaipur, Rajasthan, 302017, India|Star Hospital, Hyderabad, Telangana, 500034, India |
| URL: | https://clinicaltrials.gov/show/NCT04215120 |

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