Clinical Trial Details
| Trial ID: | L1478 |
| Source ID: | NCT05510323 |
| Associated Drug: | Prednisolone |
| Title: | Efficacy of Immunosuppressive Therapy for IgA Nephropathy With Stage 3 or 4 CKD |
| Acronym: | |
| Status: | RECRUITING |
| Study Results: | NO |
| Results: | |
| Conditions: | Glomerulonephritis, IGA |
| Interventions: | DRUG: Prednisolone|DRUG: Prednisolone plus Cyclophosphamide |
| Outcome Measures: | Primary: Combined event, 40% decrease in eGFR, ESRD or death due to kidney disease, up to 6 years | Secondary: Proteinuria remission at 6, 12 months and total follow-up period, Proteinuria remission, up to 6 years|Hematuria remission at 6, 12 months and total follow-up period, Hematuria remission, up to 6 years|The composite of 30% decrease in eGFR, ESRD and all cause death, up to 6 years|The composite of 40% decrease in eGFR, ESRD and all cause death, up to 6 years|The composite of 50% decrease in eGFR, ESRD and all cause death, up to 6 years|Annual eGFR decline rate, up to 6 years|30% decrease in eGFR, up to 6 years|40% decrease in eGFR, up to 6 years|50% decrease in eGFR, up to 6 years|ESRD, up to 6 years|All cause death, up to 6 years |
| Sponsor/Collaborators: | Sponsor: Air Force Military Medical University, China |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 208 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2024-02-01 |
| Completion Date: | 2028-08 |
| Results First Posted: | |
| Last Update Posted: | 2024-05-06 |
| Locations: | AFMMU, Xi'an, China |
| URL: | https://clinicaltrials.gov/show/NCT05510323 |
