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

Lupus Nephritis Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01288664
• Other study ID #: SYSU-PRGLN-002
• Status: Withdrawn
• Phase: Phase 3
• First received: February 1, 2011
• Last updated: February 10, 2014
• Start date: January 2011
• Est. completion date: December 2012

Study information

• Verified date: December 2013
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 65 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lupus Nephritis
• Nephritis

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Remission rate (complete or partial remission)		6 months	Yes
Secondary	proteinuria		every 3 months,up to 6 months	Yes
Secondary	Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) scores	SLEDAI (Systemic Lupus Erythematosus Disease Activity Index, Bombardier et al, 1992).	every 3 months, up to 6 months	Yes
Secondary	Number of participants with adverse events as a measure of safety and tolerability	Adverse events,including infections, transient increases in serum creatinine, gastrointestinal complaints, liver function disorder and glucose intolerance, etc.	every 3 months, up to 6 months	Yes
Secondary	renal function		every 3 months, up to 6 months	Yes
Secondary	relapse		every 3 months, up to 6 months	Yes