Home » Trials » SLCTR/2015/001
A Randomized, controlled double blind study comparing the efficacy and safety of voclosporin (23.7 mg BID, or 39.5 mg BID) with placebo in achieving remission in patients with active lupus nephritis
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SLCTR Registration Number
SLCTR/2015/001
Date of Registration
The date of last modification
Mar 03, 2019
View original TRDS
Trial Status
Scientific Title of Trial
A Randomized, controlled double blind study comparing the efficacy and safety of voclosporin (23.7 mg BID, or 39.5 mg BID) with placebo in achieving remission in patients with active lupus nephritis
Public Title of Trial
Clinical study comparing the efficacy in the achievement of the remission (measured as reduction of proteinuria) and safety of two different doses of voclosporin and non active drug (placebo) in patients suffering from active lupus nephritis
Disease or Health Condition(s) Studied
Active Lupus Nephritis
Scientific Acronym
AURA-LV: Aurinia Urinary Protein Reduction Active - Lupus With Voclosporin
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
Eudra CT number : EUCTR2012-003364-51-ES , Clinicaltrials.gov identifier: NCT02141672
What is the research question being addressed?
Is adding voclosporin to standard of care in patients with active lupus nephritis safe and effective in achieving complete disease remission after 24 weeks of treatment?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded
Control
Active
Assignment
Parallel
Purpose
Treatment
Study Phase
Phase 2
Intervention(s) planned
Study setting: Specialist tertiary care centres
Number of arms: Three
1. Voclosporin 23.7 mg twice daily for 48 weeks
2. Voclosporin 39.5 mg twice daily for 48 weeks
3. Matching placebo twice daily for 48 weeks
All subjects will receive initial treatment with intravenous (IV) methylprednisolone, followed by a reducing taper of oral corticosteroid. Additionally, all subjects will receive background therapy with mycophenolatemofetil (MMF).
Inclusion criteria
Male or female subjects aged 18 to 75 years inclusive at the time of screening.
Diagnosis of systemic lupus erythematosus (SLE) according to the American College of Rheumatology criteria (1997; see Appendix 7)
Kidney biopsy within 6 months prior to screening (Visit I) with a histologic diagnosis of lupus nephritis (Nephrology/Renal Pathology Society 2003 classification of lupus nephritis) Classes III, IV-S or IV-G (A) or (A/C): or Class V, alone or in combination with Class III or IV: see Appendix 5.
4.Subjects with laboratory evidence of active nephritis at screening, defined as follows:
• Class III, IV-S or IV-G: Confirmed proteinuria ? 1,500 mg/24 hours when assessed by 24- hour urine collection, defined by a urine protein/creatinine ratio (UPCR) of ?1.5 mg/mg assessed in a first morning void urine specimen (2 samples). • Class V (alone or in combination with class III or IV) Confirmed proteinuria ?2,000 mg/24 hours when assessed by 24-hour urine collection, defined by a UPCR of ?2 mg/mg assed in a first morning void urine collection specimen (2 samples)
Exclusion criteria
Primary outcome(s)
|
1.
The number of subjects achieving complete remission at 24 Weeks. Complete remission is defined as: Confirmed protein/creatinine ratio of ?0.5 mg/mg and no confirmed decrease from baseline in eGFR of ?20%. Subjects who receive rescue medication for lupus or ?10 mg prednisone after Week 16 will not be considered as achieving complete remission. |
[ Week 24 ] |
Secondary outcome(s)
|
1.
Complete remission as per the primary endpoint analyzed at Week 48 compared to placebo in subjects with active lupus nephritis. |
[ At 24 and 48 weeks. ] |
|
2.
Complete remission in the presence of low dose steroids at Week 24 and Week 48. |
[ At 24 and 48 weeks. ] |
|
3.
Complete remission in the presence of low dose steroids at Week 24 (defined as confirmed complete remission and ?5 mg prednisone for ?8 weeks) and Week 48 (defined as confirmed complete remission and ?5 mg prednisone for ?12 weeks). |
[ At 24 and 48 weeks. ] |
|
4.
Time to (and proportion achieving) early, sustained complete remission, defined as complete remission which occurs on or before Week 24 which is sustained through Week 48. |
[ At 24 and 48 weeks. ] |
|
5.
Time to sustained partial remission, defined as the first occurrence of partial remission which is sustained through Week 48 |
[ At 24 and 48 weeks. ] |
|
6.
Duration of complete remission (in months) |
[ At 24 and 48 weeks. ] |
|
7.
Time to complete remission |
[ At 24 and 48 weeks. ] |
|
8.
Partial remission, defined by 50% reduction in protein/creatinine ratio from baseline at Weeks 24 and 48 |
[ At 24 and 48 weeks. ] |
Target number/sample size
258 patients from Sri Lanka (total recruitment)
Countries of recruitment
Argentina, Belarus, Bulgaria, Ecuador, Georgia, Guatemala, Mexico, Poland, Russian Federation, Serbia, Spain, Sri Lanka, Ukraine, United States
Anticipated start date
2015-01-20
Anticipated end date
2016-04-29
Date of first enrollment
2015-05-15
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
Aurinia Pharmaceuticals Inc. #1203 - 4464 Markham Street Victoria, BC V8Z 7X8 Canada
Regulatory approvals
Approved (MTS/CP/P4/CT23/2014)
Status
Approved
Date of Approval
2014-07-09
Approval number
P111/07/2014
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Kelaniya |
| Institutional Address: | PO Box 6, Thalagolla Road, Ragama Sri Lanka |
| Telephone: | +94-11-2961267 |
| Email: | erckelaniya@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr Chula Herath
Consultant Nephrologist
Nephrology dialysis and Transplant unit,
Sri Jayewardenepura General Hospital, Thalapathpitiya,
Nugegoda.
Sri Lanka 10250
+94112778610
+94773017025
chulaherath@gmail.com
Contact Person for Public Queries
Prof. Asita de Silva
Director
Clinical Trials Unit,
Faculty of Medicine, University of Kelaniya
Thalagolla Road, Ragama, Sri Lanka
+94 112665266
asita@remediumone.com
Primary study sponsor/organization
Aurinia Pharmaceuticals Inc.
#1203 - 4464 Markham Street
Victoria, BC
V8Z 7X8
Canada
Phone: +250-708-4272
Fax: +250-744-2498
http://www.auriniapharma.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
