NCT00125307

Brief Summary

The investigators study the efficacy and safety of tacrolimus in the treatment of membranous nephritis secondary to systemic lupus erythematosus.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2004

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 29, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 1, 2005

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

August 3, 2015

Status Verified

May 1, 2008

Enrollment Period

3.8 years

First QC Date

July 29, 2005

Last Update Submit

July 31, 2015

Conditions

Lupus NephritisLupus Erythematosus, Systemic

Keywords

SLEglomerulonephritisimmunosuppressive therapytype V (membranous) lupus nephritis

Outcome Measures

Primary Outcomes (1)

  • Change in 24-hour urinary protein excretion

Secondary Outcomes (2)

  • Development of renal flare

  • Development of non-renal flare

Interventions

tacrolimusDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Fulfill the revised American College of Rheumatology criteria for SLE
  • Have biopsy-proven membranous nephropathy secondary to SLE
  • Nephrotic syndrome with proteinuria (\> 3 g/day) and serum albumin \< 30 g/dl, with or without active urinary sediments despite steroid therapy (with or without cytotoxic agents)
  • Age over 18 with informed consent
  • Female patients of child-bearing age and male patients who agree to maintain effective birth control practice during the study

You may not qualify if:

  • Patient with abnormal liver function tests
  • Patient with hepatitis B surface antigen or who is hepatitis C antibody positive
  • Patient who is diabetic
  • Patient who is receiving non-steroidal anti-inflammatory drugs (NSAIDs) or other agents known to influence urinary protein excretion
  • Patient is allergic or intolerant to macrolide antibiotics or tacrolimus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medicine & Therapeutics, Prince of Wales Hospital

Shatin, Hong Kong

Location

MeSH Terms

Conditions

Lupus NephritisLupus Erythematosus, SystemicGlomerulonephritis

Interventions

Tacrolimus

Condition Hierarchy (Ancestors)

NephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Cheuk-Chun Szeto, MD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 29, 2005

First Posted

August 1, 2005

Study Start

January 1, 2004

Primary Completion

October 1, 2007

Study Completion

February 1, 2008

Last Updated

August 3, 2015

Record last verified: 2008-05

Locations

HK(1)