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

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Sponsor:
Information provided by:
Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01288664
First received: February 1, 2011
Last updated: February 10, 2014
Last verified: December 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • proteinuria [ Time Frame: every 3 months,up to 6 months ] [ Designated as safety issue: Yes ]
  • Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) scores [ Time Frame: every 3 months, up to 6 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
  • relapse [ Time Frame: every 3 months, up to 6 months ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   14 Years to 65 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Xueqing Yu, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01288664     History of Changes
Other Study ID Numbers: SYSU-PRGLN-002
Study First Received: February 1, 2011
Last Updated: February 10, 2014
Health Authority: China: Food and Drug Administration

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

Additional relevant MeSH terms:
Lupus Nephritis
Nephritis
Glomerulonephritis
Kidney Diseases
Urologic Diseases
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014