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
Secondary identifying numbers 18864
Submission date
18/09/2006
Registration date
12/10/2006
Last edited
28/03/2017
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

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

Study information

Study designBlinded randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleA 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 acronymSIMPL
Study objectivesComparison 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) studiedSystemic lupus erythematosus and lupus nephritis
InterventionPrednisone/Prednisilone 7.5 mg versus placebo
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Corticosteroids
Primary outcome measureTime to flare of SLE
Secondary outcome measures1. 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 study start date30/09/2006
Completion date31/12/2007

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants30
Key inclusion criteria1. 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 criteria1. 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 enrolment30/09/2006
Date of final enrolment31/12/2007

Locations

Countries of recruitment

  • Canada
  • United Kingdom

Study participating centre

Foothills Hospital
Calgary
T2N 2T9
Canada

Sponsor information

University of Calgary (Canada)
University/education

3330 Hospital Drive NW
Calgary
T2N 4N1
Canada

Website http://www.ucalgary.ca/
ROR logo "ROR" https://ror.org/03yjb2x39

Funders

Funder type

Hospital/treatment centre

Centre for Advancement of Health (Canada)

No information available

Division of Nephrology (Canada)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

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

Editorial Notes

28/03/2017: Publication reference added.