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Long-Acting Tacrolimus for the Treatment of Resistant Lupus Nephritis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01206569
First Posted: September 22, 2010
Last Update Posted: December 4, 2012
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 (Responsible Party):
Cheuk-Chun SZETO, Chinese University of Hong Kong
  Purpose
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.

Condition Intervention Phase
Lupus Nephritis Drug: Long-acting tacrolimus (Advagraf, Astellas Pharma) Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long-Acting Tacrolimus for the Treatment of Resistant Lupus Nephritis

Resource links provided by NLM:


Further study details as provided by Cheuk-Chun SZETO, Chinese University of Hong Kong:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 2
Study Start Date: September 2010
Study Completion Date: February 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

  Eligibility

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  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): NCT01206569


Locations
Hong Kong
Prince of Wales Hospital
Shatin, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong
  More Information

Responsible Party: Cheuk-Chun SZETO, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01206569     History of Changes
Other Study ID Numbers: AFKLN
First Submitted: September 21, 2010
First Posted: September 22, 2010
Last Update Posted: December 4, 2012
Last Verified: December 2012

Keywords provided by Cheuk-Chun SZETO, Chinese University of Hong Kong:
glomerulonephritis
systemic lupus erythematosus

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