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Long-Acting Tacrolimus for the Treatment of Resistant Lupus Nephritis

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ClinicalTrials.gov Identifier: NCT01206569
Recruitment Status : Completed
First Posted : September 22, 2010
Last Update Posted : December 4, 2012
Sponsor:
Information provided by (Responsible Party):
Cheuk-Chun SZETO, Chinese University of Hong Kong

Tracking Information
First Submitted Date  ICMJE September 21, 2010
First Posted Date  ICMJE September 22, 2010
Last Update Posted Date December 4, 2012
Study Start Date  ICMJE September 2010
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 21, 2010)
overall clinical response [ Time Frame: 6 months ]
complete response is defined as urinary protein < 0.5 g/day, with normal urinary sediment, normal serum albumin, and serum creatinine < 15% above the base-line value. Partial response is defined as urinary protein between 0.6 and 2.9 g/day, with a serum albumin > 30 g/dL, and stable renal function. No response is defined as urinary protein > 3 g/day or a value of 0.6 to 2.9 g/day but serum albumin < 30 g/dL, an increase in serum creatinine ≥ 50 µmol/l or 15% above the base-line value, or the discontinuation of treatment due to side effects.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01206569 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 21, 2010)
  • change in SLEDAI score [ Time Frame: 6 months ]
  • 24-hour urinary protein excretion [ Time Frame: 6 months ]
  • renal function [ Time Frame: 6 months ]
  • development of lupus flare (renal or non-renal) [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Long-Acting Tacrolimus for the Treatment of Resistant Lupus Nephritis
Official Title  ICMJE Long-Acting Tacrolimus for the Treatment of Resistant Lupus Nephritis
Brief Summary Glomerulonephritis is one of the major disease manifestations of systemic lupus erythematosus (SLE). Around one-third of the patients, however, do not respond to conventional immunosuppressive therapy, and they have a high risk of progressing to dialysis-dependent renal failure. Recent studies suggest that immunosuppressive therapy targeted against the calcineurin pathway of T-helper cell, for example, tacrolimus, may be effective in the treatment of primary glomerulonephritis. The investigators plan to an open-label single-arm study the efficacy and safety of long-acting tacrolimus in the treatment of treatment-resistant lupus nephritis. Twenty-five patients with biopsy-proven lupus nephritis will be recruited. They will be treated with oral prednisolone and long-acting tacrolimus for 6 months, followed by 6 months of maintenance steroid and azathioprine. Proteinuria, renal function, clinical and serologic lupus activity will be monitored. This study will explore the potential role of long-acting tacrolimus in resistant lupus nephritis, which has a poor prognosis and no effective treatment at the moment.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lupus Nephritis
Intervention  ICMJE Drug: Long-acting tacrolimus (Advagraf, Astellas Pharma)
Long-acting tacrolimus (Advagraf, Astellas Pharma) will be started at single daily dose of 0.15-0.2 mg/kg/day for 6 months.
Study Arms  ICMJE Experimental: advagraf
Long-acting tacrolimus (Advagraf, Astellas Pharma) will be started at single daily dose of 0.15-0.2 mg/kg/day for 6 months.
Intervention: Drug: Long-acting tacrolimus (Advagraf, Astellas Pharma)
Publications * Not Provided

*   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: December 3, 2012)
2
Original Estimated Enrollment  ICMJE
 (submitted: September 21, 2010)
25
Actual Study Completion Date  ICMJE February 2012
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age over 18 with informed consent.
  • Fulfill the revised American College of Rheumatology criteria for SLE
  • Biopsy-proven class III, IV, or V lupus nephritis within the past 24 months.
  • Could not achieve complete remission after at least 4 months of conventional therapy (oral steroid plus cyclosphosphamide or mycophenolate mofetil).
  • NB. Complete response is defined as proteinuria less than 0.5 g/day, with normal urinary sediment, a normal serum albumin concentration, and serum creatinine <15% above the base-line value.
  • Female patients of child-bearing age and male patients agree to maintain effective birth control practice during the study.

Exclusion Criteria:

  • Abnormal liver function tests
  • Hepatitis B surface antigen or hepatitis C antibody positive
  • Diabetic
  • Receiving NSAID or other agents known to influence urinary
  • Protein excretion
  • Allergic or intolerant to macrolide antibiotics or tacrolimus
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (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 Hong Kong
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01206569
Other Study ID Numbers  ICMJE AFKLN
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cheuk-Chun SZETO, Chinese University of Hong Kong
Study Sponsor  ICMJE Chinese University of Hong Kong
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Chinese University of Hong Kong
Verification Date December 2012

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