To study the efficacy and safety of tacrolimus in the treatment of membranous nephritis secondary to systemic lupus erythematosus.

Condition	Intervention	Phase
type V (membranous) lupus nephritis	Drug: tacrolimus	Phase IV

Further Study Details: 

Primary Outcomes: Change in 24-hour urinary protein excretion
Secondary Outcomes: Development of renal flare; Development of non-renal flare
Expected Total Enrollment:  20

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 cell, for example, tacrolimus, may be effective in the treatment of primary membranous nephropathy. We plan to an open-label single-arm study 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 steroid 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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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 agree to maintain effective birth control practice during the study

Exclusion Criteria:

• Patient with abnormal liver function tests
• Patient who is hepatitis B surface antigen or hepatitis C antibody positive
• Patient who is diabetic
• Patient who is receiving NSAID or other agents known to influence urinary protein excretion
• Patient is allergic or intolerant to macrolide antibiotics or tacrolimus

Please refer to this study by ClinicalTrials.gov identifier  NCT00125307

Cheuk-Chun Szeto, MD      852-2632-3593    ccszeto@cuhk.edu.hk

Hong Kong
      Department of Medicine & Therapeutics, Prince of Wales Hospital, Shatin,  Hong Kong; Recruiting

Study chairs or principal investigators

Cheuk-Chun Szeto, MD,  Principal Investigator,  The Chinese University of Hong Kong   

Study ID Numbers:  CRE-2004.229-T; CRE-2004.229-T
Last Updated:  August 1, 2005
Record first received:  July 29, 2005
ClinicalTrials.gov Identifier:  NCT00125307
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee; Hong Kong: Department of Health
ClinicalTrials.gov processed this record on 2005-08-02