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

NCT ID: NCT01288664

Last Updated: 2014-02-12

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2012-12-31

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).

Conditions

Lupus Nephritis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ADVAGRAF

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

Group Type: EXPERIMENTAL

ADVAGRAF

Intervention Type: DRUG

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.

Interventions

ADVAGRAF

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.

Intervention Type: DRUG

Other Intervention Names

ADVAGRAF:Tacrolimus Sustained-release Capsules

Eligibility 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.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Sun Yat-sen University

Principal Investigators

Yu Xueqing, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University

Locations

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

SYSU-PRGLN-002

Identifier Type: -

Identifier Source: org_study_id