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

Phase 3

Withdrawn

• Conditions: Lupus Nephritis
• Interventions: Drug: ADVAGRAF

• Registration Number: NCT01288664
• Lead Sponsor: Sun Yat-sen University

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-02-01
• Study First Submitted QC: 2011-02-01
• Study First Posted: 2011-02-02
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-12
• Last Update Submitted: 2014-02-10
• Last Update Posted: 2014-02-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Remission rate (complete or partial remission)	6 months

Secondary Outcome Measures

Name	Time	Method
renal function	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.
relapse	every 3 months, up to 6 months
proteinuria	every 3 months,up to 6 months

Trial Locations

Locations (1)

The First Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China