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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified December 2007 by Seoul National University Hospital.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT00569101

First received: December 4, 2007

Last updated: NA

Last verified: December 2007

History: No changes posted

Tracking Information

First Received Date ^ICMJE

December 4, 2007

Last Updated Date

December 4, 2007

Start Date ^ICMJE

September 2007

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Reducing proteinuria [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Lupus Nephritis

Intervention ^ICMJE

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

Study Arm (s)

Experimental: single

single arm study (tacrolimus trial group)

Intervention: Drug: tacrolimus

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

March 2008

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT00569101

Other Study ID Numbers ^ICMJE

H-0706-049-211, 20070217867

Has Data Monitoring Committee

Yes

Responsible Party

Suhnggwon Kim, Seoul National University Hospital

Study Sponsor ^ICMJE

Seoul National University Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Suhnggwon Kim, MD, PhD

Korea : Seoul National University Hospital

Information Provided By

Seoul National University Hospital

Verification Date

December 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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