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
Scientific
Division of Nephrology
Foothills Hospital
1403-29th St NW
Calgary
T2N 2T9
Canada
| Phone | +1 (0)403 944 1110 |
|---|---|
| Braden.Manns@CalgaryHealthRegion.ca |
Study information
| Study design | Blinded randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 30/09/2006 |
| Completion date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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 |
Locations
Countries of recruitment
- Canada
- United Kingdom
Study participating centre
Foothills Hospital
Calgary
T2N 2T9
Canada
T2N 2T9
Canada
Sponsor information
University of Calgary (Canada)
University/education
University/education
3330 Hospital Drive NW
Calgary
T2N 4N1
Canada
| Website | http://www.ucalgary.ca/ |
|---|---|
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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.
