NCT00371319

Brief Summary

The purpose of this study is comparing the efficacy of tacrolimus and mycophenolate mofetil for the initial therapy of active lupus glomerulonephritis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2005

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 1, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 4, 2006

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

July 2, 2014

Status Verified

July 1, 2014

Enrollment Period

8.7 years

First QC Date

September 1, 2006

Last Update Submit

July 1, 2014

Conditions

Lupus Nephritis

Keywords

lupusnephritistacrolimusmycophenolate mofetil

Outcome Measures

Primary Outcomes (1)

  • remission rate

    month 6

Secondary Outcomes (1)

  • renal function deterioration, relapse and mortality

    month 60

Study Arms (2)

Tacrolimus

ACTIVE COMPARATOR

Tacrolimus treatment

Drug: tacrolimus

mycophenolate mofetil

ACTIVE COMPARATOR

mycophenolate mofetil

Drug: mycophenolate mofetil

Interventions

tacrolimusDRUG

0.06-0.1 mg/kg/day

Also known as: Prograf
Tacrolimus
mycophenolate mofetilDRUG

2-3 gm/day

Also known as: Cellcept
mycophenolate mofetil

Eligibility Criteria

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

You may qualify if:

  • Patients who fulfill at least 4 of the ACR criteria for SLE
  • Age \>= 18 years
  • Biopsy proven active lupus glomerulonephritis (ISN/RPS class III/IV/V)
  • Serum creatinine \< 200 umol/L at the time of randomization

You may not qualify if:

  • Patients who refuse to be randomized for treatment
  • Patients who prefer treatment with conventional agents such as oral or intravenous CYC for various reasons
  • Serum creatinine \>= 200 umol/L at the time of randomization
  • Patients without renal biopsy or those who have lupus nephritis ISN/RPS class I,II,VI
  • Patients who are pregnant or plan for pregnancy within 12 months after randomization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tuen Mun Hospital

Hong Kong, China

Location

Related Publications (2)

  • Mok CC, Ho LY, Ying SKY, Leung MC, To CH, Ng WL. Long-term outcome of a randomised controlled trial comparing tacrolimus with mycophenolate mofetil as induction therapy for active lupus nephritis. Ann Rheum Dis. 2020 Aug;79(8):1070-1076. doi: 10.1136/annrheumdis-2020-217178. Epub 2020 May 24.

    PMID: 32448782DERIVED

  • Mok CC, Ying KY, Yim CW, Siu YP, Tong KH, To CH, Ng WL. Tacrolimus versus mycophenolate mofetil for induction therapy of lupus nephritis: a randomised controlled trial and long-term follow-up. Ann Rheum Dis. 2016 Jan;75(1):30-6. doi: 10.1136/annrheumdis-2014-206456. Epub 2014 Dec 30.

    PMID: 25550339DERIVED

MeSH Terms

Conditions

Lupus NephritisNephritis

Interventions

TacrolimusMycophenolic Acid

Condition Hierarchy (Ancestors)

GlomerulonephritisKidney 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

  • CC MOK, MD, FRCP

    Tuen Mun Hospital Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant

Study Record Dates

First Submitted

September 1, 2006

First Posted

September 4, 2006

Study Start

September 1, 2005

Primary Completion

May 1, 2014

Study Completion

June 1, 2014

Last Updated

July 2, 2014

Record last verified: 2014-07

Locations

CN(1)