| Trial ID: | L0146 |
| Source ID: | NCT05515367
|
| Associated Drug: |
Desidustat
|
| 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)
|
| Acronym: |
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Kidney Diseases|Anemia of Chronic Kidney Disease
|
| Interventions: |
DRUG: Desidustat
|
| Outcome Measures: |
Primary: To asses the Proportion of Subjects with treatment emergent adverse events., Baseline (week 0) to Week 52 (end of treatment)|To asses the Proportion of Subjects with treatment emergent Serious adverse events., Baseline (week 0) to Week 52 (end of treatment) | Secondary: Mean change in hemoglobin level, Baseline (week 0) to Week 52 (end of treatment)|Mean change in Lipid profile including Small dense LDL from baseline, Baseline (week 0) to Week 52 (end of treatment)|Mean change in VEGF, Baseline (week 0) to Week 52 (end of treatment)|Mean change in serum Hepcidin, Baseline (week 0) to Week 52 (end of treatment)
|
| Sponsor/Collaborators: |
Sponsor: Zydus Lifesciences Limited
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
1004
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2023-04-20
|
| Completion Date: |
2025-11-30
|
| Results First Posted: |
|
| Last Update Posted: |
2025-01-22
|
| Locations: |
Indira Gandhi Institute of Medical Sciences, Sheikhpura, Bihar, 800014, India
|
| URL: |
https://clinicaltrials.gov/show/NCT05515367
|
