A Pilot Study for the Efficacy and Safety of Tacrolimus in the Treatment of Refractory Lupus Nephritis

Lupus Nephritis Clinical Trial

Official title:

A Pilot Study for the Efficacy and Safety of Tacrolimus in the Treatment of Refractory Lupus Nephritis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00569101
• Other study ID #: H-0706-049-211
• Secondary ID: 20070217867
• Status: Active, not recruiting
• Phase: Phase 2
• First received: December 4, 2007
• Last updated: December 4, 2007
• Start date: September 2007
• Est. completion date: March 2008

Study information

• Verified date: December 2007
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this protocol is to determine whether Tacrolimus and Prednisolone are effective and safe in the treatment of the cyclophosphamide-resistant, refractory diffuse proliferative lupus nephritis

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 9
• Est. completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Biopsy-proven lupus nephritis WHO Class IV , IV+V

• Previously treated by three times over of i.v. cyclophosphamide or 6 months more duration of immunosuppressive treatments (azathioprine, MMF, cyclophosphamide p.o.) for the lupus nephritis

• spot urine Protein creatinine raio > 1.0

• RBC > 5 /HPF on microscopic examination of urine

Exclusion Criteria:

• previous treatment of cyclosporine A or tacrolimus

• serum Creatinine lever : over 300 mmol/dl

• allergy to the macrolide antibiotics

• other systemic organ damage

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lupus Nephritis
• Nephritis

Intervention

Drug:
• tacrolimus
during the first 2 months : tacrolimus 0.1 mg/kg + prednisolone 0.8 mg/kg p.o. ,then after : tacrolimus 0.1 mg ~0.02 mg/kg + prednisolone tapering

Locations

Country	Name	City	State
Korea, Republic of	SeoulNUH	Seoul	Chongno-gu

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reducing proteinuria		6 months	Yes