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

This study has been withdrawn prior to enrollment.
(sponsor withdraw from this study)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01288664
First Posted: February 2, 2011
Last Update Posted: February 12, 2014
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.
Information provided by:
Sun Yat-sen University
  Purpose
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 Intervention Phase
Lupus Nephritis Drug: ADVAGRAF Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

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

Secondary Outcome Measures:
  • proteinuria [ Time Frame: every 3 months,up to 6 months ]
  • 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).

  • 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.

  • renal function [ Time Frame: every 3 months, up to 6 months ]
  • relapse [ Time Frame: every 3 months, up to 6 months ]

Enrollment: 0
Study Start Date: January 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ADVAGRAF
Tacrolimus Sustained-release Capsules (ADVAGRAF) treatment in induction phase for 6 months
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.
Other Name: ADVAGRAF:Tacrolimus Sustained-release Capsules

  Eligibility

Information from the National Library of Medicine

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

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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01288664


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

Responsible Party: Xueqing Yu, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01288664     History of Changes
Other Study ID Numbers: SYSU-PRGLN-002
First Submitted: February 1, 2011
First Posted: February 2, 2011
Last Update Posted: February 12, 2014
Last Verified: December 2013

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

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