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

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).

Study Overview

• Status: Completed
• Conditions: Nephritis, Lupus
• Intervention / Treatment: Drug: Tacrolimus Sustained-release Capsules (ADVAGRAF)

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • The First Affiliated Hospital of Sun Yat-sen University IRB

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ADVAGRAF; Tacrolimus Sustained-release Capsules (ADVAGRAF) treatment in induction phase	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.; Other Names: ADVAGRAF: Tacrolimus Sustained-release Capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Remission rate (complete or partial remission)	6 months after therapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The changes of proteinuria		every 3 months up to 6 months
SLEDAI scores	SLEDAI:Systemic Lupus Erythematosus Disease Activity Index (Bombardier et al, 1992).	every 3 months up to 6 months
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
The changes of renal function		every 3 months up to 6 months
Relapse		every 3 months up to 6 months

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: February 1, 2011
• First Submitted That Met QC Criteria: April 1, 2011
• First Posted (Estimate): April 5, 2011

Study Record Updates

• Last Update Posted (Estimate): November 3, 2011
• Last Update Submitted That Met QC Criteria: November 1, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: Tacrolimus; Nephritis, Lupus
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Kidney Diseases; Urologic Diseases; Connective Tissue Diseases; Glomerulonephritis; Lupus Erythematosus, Systemic; Nephritis; Lupus Nephritis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Immunosuppressive Agents; Immunologic Factors; Calcineurin Inhibitors; Tacrolimus
• Other Study ID Numbers: SYSU-PRGLN-003