Nephritis, Lupus
Conditions
Keywords
Nephritis, Lupus, Tacrolimus
Brief summary
This a pilot study to evaluate the efficacy and safety of Tacrolimus Sustained-release Capsules (ADVAGRAF) treatment for the induction therapy of refractory lupus nephritis (LN).
Interventions
Started: 0.05-0.1mg/kg/d, one time per day, the blood level 5-10ng/ml in the induction treatment.
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 SLE according to the ACR criteria (1997); 3. Kidney biopsy within the 6 months prior to study with a histologic diagnosis (ISN/RPS 2003 classification of LN) class IV, V, V+ III, V+ IV; 4. Usage of intravenous pulse cyclophosphamide for more than 3 times or immunosuppression therapy (AZA, MMF, oral cyclophosphamide, ect) for more than 6 months; 5. proteinuria \> 1g/24hr or Scr \> 1.3 mg/dl or active urinary sediment (erythrocyte cast, \> 5 WBC/high power field (hpf) (excluding infection), \> 5 RBC/hpf); 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, CTX, CysA, MTX etc) for more than 1 week within 1 month or intravenous MP Pulse treatment prior to entry; 3. Scr \> 4mg/dl (354umol/L); 4. Needing pulse intravenous MP or intravenous immunoglobulin; 5. Lupus encephalopathy; 6. Diagnosed DM; Malignant tumors (except fully cured basal cell carcinoma); 7. History of significant gastrointestinal disorders (e.g. active peptic ulcer disease or pancreatitis) within 3 month prior to enter this study; 8. Known hypersensitivity or contraindication to tacrolimus, corticosteroids 9. Any Active systemic infection or history of serious infection within one month of entry or known infection with HIV, hepatitis B, or hepatitis C; 10. Participation in another clinic trial and/or receipt of investigational drugs within 4 weeks prior to screening; 11. 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 after therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The changes of proteinuria | every 3 months up to 6 months | — |
| 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. |
| The changes of renal function | every 3 months up to 6 months | — |
| Relapse | every 3 months up to 6 months | — |
Countries
China
Outcome results
None listed