Overview

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

Status:
Withdrawn

Trial end date:
2012-12-01

Target enrollment:
0

Participant gender:
All

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).

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Sun Yat-sen University

Treatments:

Tacrolimus

Criteria

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.