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Steroids in the Maintenance of Remission of Proliferative Lupus Nephritis

NCT ID: NCT00539799

Last Updated: 2008-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Lupus Nephritis

Keywords

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systemic lupus erythematosus lupus nephritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

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

Group Type ACTIVE_COMPARATOR

prednisolone

Intervention Type DRUG

5 - 7.5 mg/day

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matched placebo to prednisolone

Interventions

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prednisolone

5 - 7.5 mg/day

Intervention Type DRUG

Placebo

Matched placebo to prednisolone

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* currently pregnant
* in end-stage renal failure
* receiving corticosteroids for an indication other than lupus nephritis
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cambridge University Hospitals NHS Foundation Trust

OTHER

Sponsor Role lead

Principal Investigators

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David Jayne, MD

Role: PRINCIPAL_INVESTIGATOR

Cambridge University Hospitals NHS Foundation Trust

Michael Walsh, MD

Role: PRINCIPAL_INVESTIGATOR

Cambridge University Hospitals NHS Foundation Trust

Locations

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Addenbrooke's Hospital

Cambridge, Cambridgeshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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EUDRACT: 2007-003923-20

Identifier Type: -

Identifier Source: secondary_id

A091040

Identifier Type: -

Identifier Source: org_study_id