NCT00298506

Brief Summary

This is an open, prospective study to assess the efficacy and safety of Tacrolimus (FK506) combined with MMF in the treatment of class III, IV, V + IV or V + III lupus nephritis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2006

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

September 29, 2011

Status Verified

September 1, 2011

Enrollment Period

3.3 years

First QC Date

March 1, 2006

Last Update Submit

September 28, 2011

Conditions

Lupus Nephritis

Keywords

TacrolimusMycophenolate mofetilCyclophosphamideLupus nephritisTreatment

Outcome Measures

Primary Outcomes (1)

  • To assess the efficacy of FK506 combined with MMF versus intravenous CTX pulses in treatment of LN

    18 months

Secondary Outcomes (1)

  • To investigate the safety and tolerability of FK506 combined with MMF versus intravenous CTX pulses

    18 months

Study Arms (1)

FK506+MMF

ACTIVE COMPARATOR
Drug: Multitherapy

Interventions

MultitherapyDRUG

Tacrolimus,4mg/d, MMF 1.0g/d

Also known as: FK506,Prograf,Tacrolimus, MMF,cellcept,mycophenolate mofetil
FK506+MMF

Eligibility Criteria

Age12 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Female patients with a diagnosis of systemic lupus erythematosus (SLE) according to the criteria of American Rheumatic Association, 1982, aged between 12-50 years, with score of SLE-DAI (Disease Active Index) of more than 12 (not including class V LN).
  • Patients diagnosed according to ISN/RPS 2003 classification criteria: class Ⅲ, Ⅳ, Ⅳ + Ⅴ, Ⅲ + Ⅴ LN by renal biopsy within 3 months, CI\< 4，Scr\< 3 mg/dl.
  • Patients with a proteinuria ≥ 1.5 g/24h, or active urine sediment.
  • Patients who signed written informed consent forms (patients less than 18 years old with their parents/legal representative' signatures), and have given their consent to follow all study procedures and follow-ups.

You may not qualify if:

  • Patients who have received treatment of cytotoxic drugs such as cyclophosphamide (CTX), cyclosporine A for more than 1 week within three months.
  • Patients with serum creatinine ≥ 3 mg/dl（265 μmol/L).
  • Patients with severe infection or central nervous system symptoms.
  • Patients who have impaired liver function, with ALT/GPT or AST/GOT twice more than the normal upper limit or who have active hepatitis.
  • Patients who have abnormal blood glucose, with a fasting blood glucose \> 6.2 mmol/L or post meal blood glucose \> 11.2 mmol/L.
  • Patients who are pregnant or lactating.
  • Patients who are known to be allergic to a macrolide.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine

Nanjing, Jiangsu, 210002, China

Location

Research Institute of Nephrology, Jinling Hospital

Nanjing, Jiangsu, 210002, China

Location

Related Publications (1)

  • Bao H, Liu ZH, Xie HL, Hu WX, Zhang HT, Li LS. Successful treatment of class V+IV lupus nephritis with multitarget therapy. J Am Soc Nephrol. 2008 Oct;19(10):2001-10. doi: 10.1681/ASN.2007121272. Epub 2008 Jul 2.

    PMID: 18596121DERIVED

MeSH Terms

Conditions

Lupus Nephritis

Interventions

TacrolimusMycophenolic Acid

Condition Hierarchy (Ancestors)

GlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLupus Erythematosus, SystemicConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic ChemicalsCaproatesAcids, AcyclicCarboxylic AcidsFatty AcidsLipids

Study Officials

  • Lei-Shi Li, M.D.

    Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Institute of Nephrology

Study Record Dates

First Submitted

March 1, 2006

First Posted

March 2, 2006

Study Start

September 1, 2005

Primary Completion

December 1, 2008

Study Completion

June 1, 2009

Last Updated

September 29, 2011

Record last verified: 2011-09

Locations

CN(2)