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A randomised controlled trial evaluating the effects of long-term low-dose corticosteroid therapy compared to placebo on flare rates during maintenance therapy for proliferative lupus nephritis: a pilot study

A randomised controlled trial evaluating the effects of long-term low-dose corticosteroid therapy compared to placebo on flare rates during maintenance therapy for proliferative lupus nephritis: a pilot study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN31327267
Enrollment
30
Registered
2006-10-12
Start date
2006-09-30
Completion date
Unknown
Last updated
2017-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic lupus erythematosus and lupus nephritis Musculoskeletal Diseases Systemic lupus erythematosus

Interventions

Prednisone/Prednisilone 7.5 mg versus placebo

Sponsors

University of Calgary (Canada)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. 18 years of age or older 2. American College of Rheumatology defined systemic lupus erythematosus 3. International Society of Nephrology/Renal Pathology Society (ISN/RPS) class III or IV lupus nephritis on last renal biopsy 4. In complete or partial remission 5. Currently on corticosteroids 6. Informed consent

Exclusion criteria

Exclusion criteria: 1. Receiving steroids for a non-Systemic Lupus Erythematosus (SLE) indication 2. Currently pregnant 3. On a form of renal replacement therapy or having received a renal transplantation

Design outcomes

Primary

MeasureTime frame
Time to flare of SLE

Secondary

MeasureTime frame
1. Time to renal flare 2. Differences in quality of life as measured by Short Form - 36 and Euroquol 5D instrument 3. Differences in disease activity as measured by British Isles Lupus Activity Grade and Systemic Lupus Erythematosus Activity Index 4. Differences in disease damage as measured by the Systemic Lupus International Collaborative Clinics/American College of Rheumatology (SLICC/ACR) damage score 5. Differences in steroid-related adverse events

Countries

Canada, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 8, 2026