Contact information
Type
Scientific
Primary contact
Dr Braden Manns
ORCID ID
Contact details
Division of Nephrology
Foothills Hospital
1403-29th St NW
Calgary
T2N 2T9
Canada
+1 (0)403 944 1110
Braden.Manns@CalgaryHealthRegion.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
18864
Study information
Scientific title
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
Acronym
SIMPL
Study hypothesis
Comparison of flare of lupus rates in patients randomised to low-dose corticosteroids to those randomised to corticosteroid discontinuation.
Ethics approval
University of Calgary Conjoint Medical Ethics Committee (Canada)
Study design
Blinded randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Systemic lupus erythematosus and lupus nephritis
Intervention
Prednisone/Prednisilone 7.5 mg versus placebo
Intervention type
Drug
Phase
Not Applicable
Drug names
Corticosteroids
Primary outcome measure
Time to flare of SLE
Secondary outcome measures
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
Overall trial start date
30/09/2006
Overall trial end date
31/12/2007
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
30
Participant 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
Recruitment start date
30/09/2006
Recruitment end date
31/12/2007
Locations
Countries of recruitment
Canada, United Kingdom
Trial participating centre
Foothills Hospital
Calgary
T2N 2T9
Canada
Sponsor information
Organisation
University of Calgary (Canada)
Sponsor details
3330 Hospital Drive NW
Calgary
T2N 4N1
Canada
Sponsor type
University/education
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Centre for Advancement of Health (Canada)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Division of Nephrology (Canada)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2014 results in: https://www.ncbi.nlm.nih.gov/pubmed/25780619