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

ISRCTN	ISRCTN31327267
DOI	https://doi.org/10.1186/ISRCTN31327267
Protocol serial number	18864
Sponsor	University of Calgary (Canada)
Funders	Centre for Advancement of Health (Canada), Division of Nephrology (Canada)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Braden Manns
Scientific

Division of Nephrology
Foothills Hospital
1403-29th St NW
Calgary
T2N 2T9
Canada

Phone	+1 (0)403 944 1110
Email	Braden.Manns@CalgaryHealthRegion.ca

Primary study design	Interventional
Study design	Blinded randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study acronym	SIMPL
Study objectives	Comparison of flare of lupus rates in patients randomised to low-dose corticosteroids to those randomised to corticosteroid discontinuation.
Ethics approval(s)	University of Calgary Conjoint Medical Ethics Committee (Canada)
Health condition(s) or problem(s) studied	Systemic lupus erythematosus and lupus nephritis
Intervention	Prednisone/Prednisilone 7.5 mg versus placebo
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Corticosteroids
Primary outcome measure(s)	Time to flare of SLE
Key secondary outcome measure(s)	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
Completion date	31/12/2007

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	30
Key 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
Key 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
Date of first enrolment	30/09/2006
Date of final enrolment	31/12/2007

Foothills Hospital

Calgary
T2N 2T9
Canada

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	28/11/2014		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

28/03/2017: Publication reference added.