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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01288664
Recruitment Status : Withdrawn (sponsor withdraw from this study)
First Posted : February 2, 2011
Last Update Posted : February 12, 2014
Information provided by:
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).

Condition or disease Intervention/treatment Phase
Lupus Nephritis Drug: ADVAGRAF Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2011
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus

Arm Intervention/treatment
Experimental: ADVAGRAF
Tacrolimus Sustained-release Capsules (ADVAGRAF) treatment in induction phase for 6 months
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.
Other Name: ADVAGRAF:Tacrolimus Sustained-release Capsules

Primary Outcome Measures :
  1. Remission rate (complete or partial remission) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. proteinuria [ Time Frame: every 3 months,up to 6 months ]
  2. Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) scores [ Time Frame: every 3 months, up to 6 months ]
    SLEDAI (Systemic Lupus Erythematosus Disease Activity Index, Bombardier et al, 1992).

  3. Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: 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.

  4. renal function [ Time Frame: every 3 months, up to 6 months ]
  5. relapse [ Time Frame: every 3 months, up to 6 months ]

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Ages Eligible for Study:   14 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01288664

China, Guangdong
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510080
Sponsors and Collaborators
Sun Yat-sen University
Principal Investigator: Yu Xueqing, MD Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University

Responsible Party: Xueqing Yu, Sun Yat-sen University Identifier: NCT01288664     History of Changes
Other Study ID Numbers: SYSU-PRGLN-002
First Posted: February 2, 2011    Key Record Dates
Last Update Posted: February 12, 2014
Last Verified: December 2013

Keywords provided by Sun Yat-sen University:
Lupus Nephritis
Induction Phase

Additional relevant MeSH terms:
Lupus Nephritis
Kidney Diseases
Urologic Diseases
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action