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

Seoul National University

Status and phase: Unknown; Phase 2

Conditions: Lupus Nephritis

Treatments: Drug: tacrolimus

Study type: Interventional

Funder types: Other

Identifiers

NCT00569101

20070217867

H-0706-049-211

Details and patient eligibility

About

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

Enrollment: 9 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

9 participants in 1 patient group

single

Experimental group

Description:

single arm study (tacrolimus trial group)

Treatment:

Drug: tacrolimus