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

Phase 3

Completed

• Conditions: Nephritis, Lupus
• Interventions: Drug: Tacrolimus Sustained-release Capsules (ADVAGRAF)

• Registration Number: NCT01328834
• Lead Sponsor: Sun Yat-sen University

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-02-01
• Study First Submitted QC: 2011-04-01
• Study First Posted: 2011-04-05
• Status Verified: 2011-10
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Last Update Submitted: 2011-11-01
• Last Update Posted: 2011-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
The changes of proteinuria	every 3 months up to 6 months
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.
The changes of renal function	every 3 months up to 6 months
Relapse	every 3 months up to 6 months

Trial Locations

Locations (1)

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