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

Nephritis, Lupus Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01328834
• Other study ID #: SYSU-PRGLN-003
• Status: Completed
• Phase: Phase 3
• First received: February 1, 2011
• Last updated: November 1, 2011
• Start date: January 2011
• Est. completion date: October 2011

Study information

• Verified date: October 2011
• 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 a pilot study to evaluate the efficacy and safety of Tacrolimus Sustained-release Capsules (ADVAGRAF) treatment for the induction therapy of refractory lupus nephritis (LN).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• 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 SLE according to the ACR criteria (1997);

3. Kidney biopsy within the 6 months prior to study with a histologic diagnosis (ISN/RPS 2003 classification of LN) class IV, V, V+ III, V+ IV;

4. Usage of intravenous pulse cyclophosphamide for more than 3 times or immunosuppression therapy (AZA, MMF, oral cyclophosphamide, ect) for more than 6 months;

5. proteinuria > 1g/24hr or Scr > 1.3 mg/dl or active urinary sediment (erythrocyte cast, > 5 WBC/high power field (hpf) (excluding infection), > 5 RBC/hpf);

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, CTX, CysA, MTX etc) for more than 1 week within 1 month or intravenous MP Pulse treatment prior to entry;

3. Scr > 4mg/dl (354umol/L);

4. Needing pulse intravenous MP or intravenous immunoglobulin;

5. Lupus encephalopathy;

6. Diagnosed DM; Malignant tumors (except fully cured basal cell carcinoma);

7. History of significant gastrointestinal disorders (e.g. active peptic ulcer disease or pancreatitis) within 3 month prior to enter this study;

8. Known hypersensitivity or contraindication to tacrolimus, corticosteroids

9. Any Active systemic infection or history of serious infection within one month of entry or known infection with HIV, hepatitis B, or hepatitis C;

10. Participation in another clinic trial and/or receipt of investigational drugs within 4 weeks prior to screening;

11. 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
• Nephritis, Lupus

Intervention

Drug:
• Tacrolimus Sustained-release Capsules (ADVAGRAF)
Started: 0.05-0.1mg/kg/d, one time per day, the blood level 5-10ng/ml in the induction treatment.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Sun Yat-sen University IRB	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 after therapy	Yes
Secondary	The changes of proteinuria		every 3 months up to 6 months	Yes
Secondary	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	The changes of renal function		every 3 months up to 6 months	Yes
Secondary	Relapse		every 3 months up to 6 months	Yes