Steroids in the Maintenance of Remission of Proliferative Lupus Nephritis

Lupus Nephritis Clinical Trial

— SIMPL  

Official title:

Corticosteroids in the Maintenance Therapy of Proliferative Lupus Nephritis: a Randomized Pilot Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00539799
• Other study ID #: A091040
• Secondary ID: EUDRACT: 2007-00
• Status: Withdrawn
• Phase: Phase 3
• First received: October 4, 2007
• Last updated: May 28, 2008

Study information

• Verified date: May 2008
• Source: Cambridge University Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 15
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lupus Nephritis
• Nephritis

Intervention

Drug:
• prednisolone
5 - 7.5 mg/day
• Placebo
Matched placebo to prednisolone

Locations

Country	Name	City	State
United Kingdom	Addenbrooke's Hospital	Cambridge	Cambridgeshire

Sponsors (1)

Lead Sponsor	Collaborator
Cambridge University Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility (recruitment rate and protocol adherence)		12 months
Secondary	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