Slctr

SLCTR Registration Number

SLCTR/2015/001

Date of Registration

20 Jan 2015

The date of last modification

Jul 15, 2015

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Application Summary

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

Trial Details

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.
Diagnosis of systemic lupus erythematosus (SLE) according to the American College of Rheumatology criteria.
Kidney biopsy within 6 months prior to Screening (Visit 1) with a histologic diagnosis of lupus nephritis (International Society of 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.
Laboratory evidence of active nephritis at screening, defined as:

• Class III: Confirmed proteinuria ?2,000 mg/24 hours when assessed by 24 hour urine collection
• Class IV-S or Class IV-G: Confirmed proteinuria ?1,500 mg/24 hours when assessed by 24 hour urine collection
• 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

Exclusion criteria

Estimated glomerular filtration rate (eGFR) as calculated by the Chronic Kidney Disease Epidemiology Collaboration equation of <45 mL/min/1.73 m2.
Currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected to require dialysis during the study period.
A previous kidney transplant or planned transplant within study treatment period.
In the opinion of the Investigator, subject does not require long-term immunosuppressive treatment (in addition to corticosteroids).

Primary outcome(s)

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. Complete remission in the presence of low dose steroids at Week 24 and Week 48. 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). 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. Time to sustained partial remission, defined as the first occurrence of partial remission which is sustained through Week 48 Duration of complete remission (in months) Complete remission at 48 weeks Time to complete remission Partial remission, defined by 50% reduction in protein/creatinine ratio from baseline at Weeks 24 and 48.	[ 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

Approximately 21 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

Date of study completion

Recruitment status

Recruiting

Funding source

Aurinia Pharmaceuticals Inc. #1203 - 4464 Markham Street Victoria, BC V8Z 7X8 Canada

Regulatory approvals

State of Ethics Review Approval

Status

Date of Approval

Approval number

Details of Ethics Review Committee

Name:
Institutional Address:
Telephone:
Email:

Contact & Sponsor Information

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

Secondary study sponsor (If any)

None

Trial Completion details

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

Date of posting results

Date of study completion

Final sample size

Date of first publication

Link to results

Brief summary of results

Original TRDS for trail "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" created on Jul 15, 2015

Application Summary

Trial Details

State of Ethics Review Approval

Contact & Sponsor Information

Trial Completion details