Lupus Nephritis
Conditions
Keywords
Lupus Nephritis, Tacrolimus, Induction Phase
Brief summary
This is a pilot study to evaluate the efficacy and safety of Tacrolimus Sustained-release Capsules (ADVAGRAF) for the induction therapy of Lupus Nephritis (LN) (V, III +V, IV+V).
Interventions
DRUGADVAGRAF
Tacrolimus Sustained-release Capsules (ADVAGRAF) Started: 0.05-0.1mg/kg/d, one time per day, the blood level:5-10ng/ml in induction phase.
Sponsors
Sun Yat-sen University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects of either sex, 14-65 years of age; 2. Diagnosis of systemic lupus erythematosus (SLE) according to the albumin-creatinine ratio (ACR) criteria (1997); 3. Kidney biopsy within the 6 months prior to study with a histologic diagnosis (ISN/RPS 2003 classification of LN) class V, III +V, IV+V; 4. LN (Class IV+V): proteinuria \> 1g/24hr or Scr \> 1.3 mg/dl or active urinary sediment (erythrocyte cast, \> 5 white blood cell count (WBC) /high power field (hpf)(excluding infection ), \> 5 red blood cell count (RBC)/hpf; 5. LN (Class V or III +V ): proteinuria \> 2g/24hr or Scr \> 1.3 mg/dl; 6. Provision of written informed consent by subject or guardian
Exclusion criteria
1. Inability or unwillingness to provide written informed consent 2. Usage of immunosuppression therapy (MMF, Cyclophosphamide (CTX), Cyclosporine A (CysA), methotrexate (MTX) ect) for more than 1 week within 1 month or Pulse intravenous MP treatment prior to recruitment 3. Scr \> 4mg/dl (354umol/L) 4. Needing pulse intravenous Methylprednisolone (MP) or intravenous immunoglobulin 5. Lupus encephalopathy 6. Diagnosed diabetes mellitus (DM); Malignant tumors (except fully cured basal cell carcinoma) 7. History of significant gastrointestinal disorders (e.g. severe chronic diarrhea or active peptic ulcer disease) within 3 month prior to enter this study 8. Any Active systemic infection or history of serious infection within one month of entry 9. known infection with HIV, hepatitis B, or hepatitis C 10. Known hypersensitivity or contraindication to tacrolimus, corticosteroids 11. Participation in another clinic trial and/or receipt of investigational drugs within 4 weeks prior to screening 12. Pregnancy, nursing or use of a non-reliable method of contraception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Remission rate (complete or partial remission) | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| proteinuria | every 3 months,up to 6 months | — |
| Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) scores | every 3 months, up to 6 months | SLEDAI (Systemic Lupus Erythematosus Disease Activity Index, Bombardier et al, 1992). |
| Number of participants with adverse events as a measure of safety and tolerability | every 3 months, up to 6 months | Adverse events,including infections, transient increases in serum creatinine, gastrointestinal complaints, liver function disorder and glucose intolerance, etc. |
| renal function | every 3 months, up to 6 months | — |
| relapse | every 3 months, up to 6 months | — |
Countries
China
Outcome results
None listed