Clinical trial NCT01206569: Long-Acting Tacrolimus for the Treatment of Resistant Lupus Nephritis
Official title: Long-Acting Tacrolimus for the Treatment of Resistant Lupus Nephritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Lupus Nephritis
Keywords: glomerulonephritis
systemic lupus erythematosus
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2010-09-22
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: overall clinical response
timeFrame: 6 months
Secondary outcomes:
measure: change in SLEDAI score
timeFrame: 6 months
measure: 24-hour urinary protein excretion
timeFrame: 6 months
measure: renal function
timeFrame: 6 months
measure: development of lupus flare (renal or non-renal)
timeFrame: 6 months
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: Prince of Wales Hospital
Study officials:
References: