NCT01203709

Brief Summary

A trial of combination of two drugs for the treatment of refractory lupus nephritis.

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 Aug 2010

Typical duration 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

August 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 16, 2010

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

March 4, 2014

Status Verified

March 1, 2014

Enrollment Period

2.3 years

First QC Date

September 15, 2010

Last Update Submit

March 3, 2014

Conditions

Lupus Nephritis

Keywords

lupusnephritisglomerulonephritisnephropathyrefractory

Outcome Measures

Primary Outcomes (1)

  • Clinical remission rate

    12 months

Secondary Outcomes (1)

  • Adverse events

    12 months

Study Arms (1)

Combination treatment

EXPERIMENTAL

treatment arm

Drug: low dose combination of MMF and Tac

Interventions

low dose combination of MMF and TacDRUG

mycophenolate mofetil 500mg BID + tacrolimus 2mg BID

Also known as: Cellcept and Prograf
Combination treatment

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Active nephritis documented by renal biopsy within 24 months of entry;
  • Failure to respond to 2 or more immunosuppressive regimens which consisted of high-dose prednisolone combined with other non-corticosteroid immunosuppressive agents together with ACE inhibitors plus or minus angiotensin receptor blockers (ARB) for at least 4 months for each regimen at the maximally tolerated drug dosages;
  • Serum creatinine (Scr) less than 200umol/L.

You may not qualify if:

  • Previous intolerance to either MMF/Tac;
  • Scr \>200umol/L;
  • Informed consent unavailable.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tuen Mun Hospital

Hong Kong, China

Location

MeSH Terms

Conditions

Lupus NephritisNephritisGlomerulonephritisKidney Diseases

Interventions

TriamcinoloneMycophenolic AcidTacrolimus

Condition Hierarchy (Ancestors)

Urologic 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)

PregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedCaproatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty AcidsLipidsMacrolidesLactones

Study Officials

  • CC Mok, MD, FRCP

    Tuen Mun Hospital, Hong Kong China

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 15, 2010

First Posted

September 16, 2010

Study Start

August 1, 2010

Primary Completion

December 1, 2012

Study Completion

February 1, 2013

Last Updated

March 4, 2014

Record last verified: 2014-03

Locations

CN(1)