Steroids in the Maintenance of Remission of Proliferative Lupus Nephritis (SIMPL)

NHS Foundation Trust

Status and phase: Withdrawn; Phase 3

Conditions: Lupus Nephritis

Treatments: Drug: prednisolone; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00539799

EUDRACT: 2007-003923-20

A091040

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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15 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

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

Treatment:

Drug: prednisolone

2

Placebo Comparator group

Treatment:

Drug: Placebo