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Comparing the Efficacy of Tacrolimus and Mycophenolate Mofetil for the Initial Therapy of Active Lupus Nephritis

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ClinicalTrials.gov Identifier: NCT00371319
Recruitment Status : Completed
First Posted : September 4, 2006
Last Update Posted : July 2, 2014
Sponsor:
Information provided by (Responsible Party):
Chi Chiu Mok, Tuen Mun Hospital

Tracking Information
First Submitted Date  ICMJE September 1, 2006
First Posted Date  ICMJE September 4, 2006
Last Update Posted Date July 2, 2014
Study Start Date  ICMJE September 2005
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2011)
remission rate [ Time Frame: month 6 ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 1, 2006)
remission rate
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2011)
renal function deterioration, relapse and mortality [ Time Frame: month 60 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 1, 2006)
renal function deterioration, relapse and mortality
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparing the Efficacy of Tacrolimus and Mycophenolate Mofetil for the Initial Therapy of Active Lupus Nephritis
Official Title  ICMJE To Compare the Efficacy of Tacrolimus and Mycophenolate Mofetil for the Initial Therapy of Active Lupus Nephritis
Brief Summary The purpose of this study is comparing the efficacy of tacrolimus and mycophenolate mofetil for the initial therapy of active lupus glomerulonephritis.
Detailed Description Patients with biopsy proven active lupus nephritis will be randomized to receive tacrolimus or mycophenolate mofetil, on top of corticosteroids, for initial treatment. Efficacy and adverse effects will be compared.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lupus Nephritis
Intervention  ICMJE
  • Drug: tacrolimus
    0.06-0.1 mg/kg/day
    Other Name: Prograf
  • Drug: mycophenolate mofetil
    2-3 gm/day
    Other Name: Cellcept
Study Arms  ICMJE
  • Active Comparator: Tacrolimus
    Tacrolimus treatment
    Intervention: Drug: tacrolimus
  • Active Comparator: mycophenolate mofetil
    mycophenolate mofetil
    Intervention: Drug: mycophenolate mofetil
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 1, 2014)
150
Original Enrollment  ICMJE
 (submitted: September 1, 2006)
100
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients who fulfill at least 4 of the ACR criteria for SLE
  2. Age >= 18 years
  3. Biopsy proven active lupus glomerulonephritis (ISN/RPS class III/IV/V)
  4. Serum creatinine < 200 umol/L at the time of randomization

Exclusion Criteria:

  1. Patients who refuse to be randomized for treatment
  2. Patients who prefer treatment with conventional agents such as oral or intravenous CYC for various reasons
  3. Serum creatinine >= 200 umol/L at the time of randomization
  4. Patients without renal biopsy or those who have lupus nephritis ISN/RPS class I,II,VI
  5. Patients who are pregnant or plan for pregnancy within 12 months after randomization
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00371319
Other Study ID Numbers  ICMJE HARECCTR0500018
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chi Chiu Mok, Tuen Mun Hospital
Study Sponsor  ICMJE Tuen Mun Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: CC MOK, MD, FRCP Tuen Mun Hospital Hong Kong
PRS Account Tuen Mun Hospital
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP