Clinical trial NCT00125307: Tacrolimus for the Treatment of Systemic Lupus Erythematosus With Membranous Nephritis
Official title: Tacrolimus for the Treatment of Systemic Lupus Erythematosus With Membranous Nephritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Lupus Nephritis
Lupus Erythematosus, Systemic
Keywords: SLE
glomerulonephritis
immunosuppressive therapy
type V (membranous) lupus nephritis
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2005-08-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators study the efficacy and safety of tacrolimus in the treatment of membranous nephritis secondary to systemic lupus erythematosus.

Detailed description: Glomerulonephritis is one of the major disease manifestations of systemic lupus erythematosus (SLE). The treatment of membranous (type V) lupus nephritis, a subset that carries a high morbidity, remains unsatisfactory. Recent studies suggest that immunosuppressive therapy targeted against the calcineurin pathway of T-helper cells, for example, tacrolimus, may be effective in the treatment of primary membranous nephropathy. The investigators plan to conduct an open-label single-arm study of the efficacy and safety of tacrolimus in the treatment of membranous nephropathy secondary to SLE. Twenty patients with biopsy-proven membranous nephropathy secondary to SLE will be recruited. They will be treated with oral prednisolone and tacrolimus for 6 months, followed by 6 months of maintenance steroids alone. Proteinuria, renal function, clinical and serologic lupus activity will be monitored. Complete remission is defined as 24-hour urinary protein excretion to less than 0.5 gm/day. This study will explore the potential role of tacrolimus in the treatment of membranous lupus nephritis, which is usually resistant to conventional therapy.

Eligibility criteria: Inclusion Criteria:

* Fulfill the revised American College of Rheumatology criteria for SLE
* Have biopsy-proven membranous nephropathy secondary to SLE
* Nephrotic syndrome with proteinuria (\> 3 g/day) and serum albumin \< 30 g/dl, with or without active urinary sediments despite steroid therapy (with or without cytotoxic agents)
* Age over 18 with informed consent
* Female patients of child-bearing age and male patients who agree to maintain effective birth control practice during the study

Exclusion Criteria:

* Patient with abnormal liver function tests
* Patient with hepatitis B surface antigen or who is hepatitis C antibody positive
* Patient who is diabetic
* Patient who is receiving non-steroidal anti-inflammatory drugs (NSAIDs) or other agents known to influence urinary protein excretion
* Patient is allergic or intolerant to macrolide antibiotics or tacrolimus

Primary outcomes:
measure: Change in 24-hour urinary protein excretion
Secondary outcomes:
measure: Development of renal flare
measure: Development of non-renal flare
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: Department of Medicine & Therapeutics, Prince of Wales Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Cheuk-Chun Szeto, MD
role: PRINCIPAL_INVESTIGATOR
References: