Long-Acting Tacrolimus for the Treatment of Resistant Lupus Nephritis

Lupus Nephritis Clinical Trial

Official title:

Long-Acting Tacrolimus for the Treatment of Resistant Lupus Nephritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01206569
• Other study ID #: AFKLN
• Status: Completed
• Phase: Phase 4
• First received: September 21, 2010
• Last updated: December 3, 2012
• Start date: September 2010
• Est. completion date: February 2012

Study information

• Verified date: December 2012
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: February 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lupus Nephritis
• Nephritis

Intervention

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.

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Shatin

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall clinical response	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.	6 months	No
Secondary	change in SLEDAI score		6 months	No
Secondary	24-hour urinary protein excretion		6 months	No
Secondary	renal function		6 months	No
Secondary	development of lupus flare (renal or non-renal)		6 months	No