Official Title: “Corticosteroids in the Maintenance Therapy of Proliferative Lupus Nephritis: a Randomized Pilot Study”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Long-term low-dose prednisolone (5 - 7.5 mg/day)
• Placebo Comparator: 2

Primary Measures

• Feasibility (recruitment rate and protocol adherence)
  • Time Frame: 12 months
    

Secondary Measures

• 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
  • Time Frame: 24 months
    

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust

Overall Clinical Trial Officials and Contacts

David Jayne, MD Principal Investigator Cambridge University Hospitals NHS Foundation Trust  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00539799

Study ID Number: A091040

ClinicalTrials.gov Identifier: NCT00539799

Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency