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

NCT ID: NCT00569101

Last Updated: 2007-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2008-03-31

Brief Summary

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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

Detailed Description

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Conditions

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Lupus Nephritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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single

single arm study (tacrolimus trial group)

Group Type EXPERIMENTAL

tacrolimus

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Seoul National University Hospital

Principal Investigators

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Suhnggwon Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Korea : Seoul National University Hospital

Locations

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SeoulNUH

Seoul, Chongno-gu, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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20070217867

Identifier Type: -

Identifier Source: secondary_id

H-0706-049-211

Identifier Type: -

Identifier Source: org_study_id