Clinical Trial Details
| Trial ID: | L1455 |
| Source ID: | NCT01207297 |
| Associated Drug: | Tacrolimus |
| Title: | Tacrolimus Versus Cyclophosphamide as Treatment for Lupus Nephritis |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | SLE|Lupus Nephritis|Renal Insufficiency|End-stage Renal Disease |
| Interventions: | DRUG: Tacrolimus|DRUG: cyclophosphamide |
| Outcome Measures: | Primary: Tacrolimus versus cyclophosphamide as treatment for diffuse proliferative or membranous lupus nephritis, The primary study outcome measure was the cumulative rate of complete remission (CR)., one year | Secondary: Evaluating the effective and safety of TAC for severe lupus nephritis compared CYC protocol., The secondary outcome measure were time required for CR, cumulative rate of sustained remission, relapse rate, immunological parameters, side effects, renal function during treatment and followed-up, and compliance with therapy and TAC dosing and serum levels., one year |
| Sponsor/Collaborators: | Sponsor: Zhejiang University |
| Gender: | ALL |
| Age: | CHILD, ADULT |
| Phases: | PHASE1 |
| Enrollment: | 40 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2003-03 |
| Completion Date: | 2010-06 |
| Results First Posted: | |
| Last Update Posted: | 2011-08-23 |
| Locations: | |
| URL: | https://clinicaltrials.gov/show/NCT01207297 |
