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

• Register: SLCTR
• Last refreshed on: 1 April 2024
• Main ID: SLCTR/2015/001
• Date of registration: 2015-01-20
• Prospective Registration: Yes
• Primary sponsor: Aurinia Pharmaceuticals Inc.
• Public title: 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
• Scientific title: 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
• Date of first enrolment: 2015-01-20
• Target sample size: 258 patients from Sri Lanka (total recruitment)
• Recruitment status: Complete: follow up complete
• URL: https://slctr.lk/trials/slctr-2015-001
• Study type: Interventional
• Study design: Randomized controlled trial
• Phase: Phase 2

Countries of recruitment

Argentina,Belarus,Bulgaria,Ecuador,Georgia,Guatemala,Mexico,Poland,Russian Federation,Serbia,Spain,Sri Lanka,Ukraine,United States

Contacts

• Name: Prof. Asita de Silva
• Affiliation: Director

• Name: Dr Chula Herath
• Affiliation: Consultant Nephrologist

Key inclusion & exclusion criteria

Inclusion criteria: 1. Male or female subjects aged 18 to 75 years inclusive at the time of screening.

2. Diagnosis of systemic lupus erythematosus (SLE) according to the American College of Rheumatology criteria (1997; see Appendix 7)

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


Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Active Lupus Nephritis

Intervention(s)

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).

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)

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

Source(s) of Monetary Support

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

Ethics review

Status: Approved
Approval date: 09/07/2014
Contact:

[e-mail]

Ethics Review Committee, Faculty of Medicine, University of Kelaniya

[phone]

[e-mail]