NCT00539799

Brief Summary

There is debate as to whether long-term low-dose steroids such as prednisolone help to suppress relapses of systemic lupus erythematosus (SLE) in patients who are in remission from their lupus nephritis. If low-dose prednisolone reduces relapses, these beneficial effects may be counter-balanced by the long-term side-effects associated with prednisolone. This pilot study will determine the feasibility of conducting a larger randomized control trial that will answer the question of whether or not long-term low-dose prednisolone (5 - 7.5 mg/day) reduces the flares of SLE in patients with previous lupus nephritis.

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for phase_3

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

October 4, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 5, 2007

Completed
Last Updated

May 29, 2008

Status Verified

May 1, 2008

First QC Date

October 4, 2007

Last Update Submit

May 28, 2008

Conditions

Lupus Nephritis

Keywords

systemic lupus erythematosuslupus nephritis

Outcome Measures

Primary Outcomes (1)

  • Feasibility (recruitment rate and protocol adherence)

    12 months

Secondary Outcomes (1)

  • 1) time to major renal and non-renal relapses of SLE 2) time to minor relapses of SLE 3) health related quality of life 4) adverse events/side-effects 5) accrual of SLE related organ damage 6) renal function

    24 months

Study Arms (2)

1

ACTIVE COMPARATOR

Long-term low-dose prednisolone (5 - 7.5 mg/day)

Drug: prednisolone

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

prednisoloneDRUG

5 - 7.5 mg/day

1
PlaceboDRUG

Matched placebo to prednisolone

2

Eligibility Criteria

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

You may qualify if:

  • age at least 18 years
  • diagnosis of SLE by ACR criteria
  • diagnosis of proliferative lupus nephritis (ISN/RPS class III or IV)
  • currently on prednisolone (5 to 20 mg/day)
  • in partial or complete remission for at least 3 months

You may not qualify if:

  • currently pregnant
  • in end-stage renal failure
  • receiving corticosteroids for an indication other than lupus nephritis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Addenbrooke's Hospital

Cambridge, Cambridgeshire, United Kingdom

Location

MeSH Terms

Conditions

Lupus NephritisLupus Erythematosus, Systemic

Interventions

Prednisolone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • David Jayne, MD

    Cambridge University Hospitals NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

  • Michael Walsh, MD

    Cambridge University Hospitals NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 4, 2007

First Posted

October 5, 2007

Last Updated

May 29, 2008

Record last verified: 2008-05

Locations

GB(1)