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

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00569101
• Collaborator: (none)
• Enrollment: 9
• Location: 1
• Arm: 1
• Duration (Months): 6
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Lupus Nephritis	Drug: tacrolimus	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 9 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Pilot Study for the Efficacy and Safety of Tacrolimus in the Treatment of Refractory Lupus Nephritis
• Study Start Date: Sep 1, 2007
• Anticipated Study Completion Date: Mar 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: single single arm study (tacrolimus trial group)	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

Outcome Measures

Primary Outcome Measures

1. Reducing proteinuria [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	SeoulNUH	Seoul	Chongno-gu	Korea, Republic of	110-744

Sponsors and Collaborators

• Seoul National University Hospital

Investigators

• Principal Investigator: Suhnggwon Kim, MD, PhD, Korea : Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00569101
• Other Study ID Numbers: H-0706-049-211; 20070217867
• First Posted: Dec 6, 2007
• Last Update Posted: Dec 6, 2007
• Last Verified: Dec 1, 2007

• Additional relevant MeSH terms: Nephritis; Lupus Nephritis; Tacrolimus

Study Results

No Results Posted as of Dec 6, 2007