Efficacy and Safety of Tacrolimus Sustained-release Capsules in Induction Phase Treatment in Lupus Nephritis

Sun Yat-sen University

Status and phase: Withdrawn; Phase 3

Conditions: Lupus Nephritis

Treatments: Drug: ADVAGRAF

Study type: Interventional

Funder types: Other

Identifiers

NCT01288664

SYSU-PRGLN-002

Details and patient eligibility

About

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).

Sex: All

Ages: 14 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

ADVAGRAF

Experimental group

Description:

Tacrolimus Sustained-release Capsules (ADVAGRAF) treatment in induction phase for 6 months

Treatment:

Drug: ADVAGRAF