Aurinia Early Urinary Protein Reduction Predicts Response

NCT02949973 | Completed Phase 2 Results

• 1 other identifier: AUR-VCS-2014-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

An exploratory study assessing the ability of biomarkers measured at 8 weeks to predict clinical response over 24 and 48 weeks in subjects taking voclosporin 23.7 mg twice daily (BID) in combination with standard of care in patients with active lupus nephritis

Conditions

Lupus Nephritis

Keywords

lupus nephritis; calcineurin inhibitors; voclosporin

Outcome Measures

Primary Outcomes (4)

• Number of Participants With Reduction or Normalization of Urine Protein/Creatinine Ratio (UPCR)

  24 weeks

• Number of Participants With Reduction or Normalization of Anti ds DNA

  24 weeks

• Number of Participants With Reduction or Normalization of C3

  24 weeks

• Number of Participants With Reduction or Normalization of C4

  24 weeks

Secondary Outcomes (2)

• Number of Participants With Complete Remission at Week 24

  week 24

• Number of Participants With Complete Remission at Week 48

  week 48

Study Arms (1)

Voclosporin

EXPERIMENTAL

Voclosporin, oral, 23.7 mg twice daily (BID)

Drug: voclosporin

Interventions

voclosporin DRUG

Also known as: ISA247

Voclosporin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of systemic lupus erythematosus (SLE) according to the American College of Rheumatology criteria (1997; see Appendix 6).
• Kidney biopsy within 24 months prior to screening with a histologic diagnosis of lupus nephritis International Society of Nephrology/Renal Pathology Society 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, IV-S or Class IV-G (proteinuria ≥1000 mg/24 hours when assessed by 24 hour urine collection, defined by a urine protein/creatinine ratio (UPCR) of ≥1.0 mg/mg assessed in a first morning void urine specimen). Class V, alone or in combination with Class III or IV, (proteinuria ≥1,500 mg/24 hours when assessed by 24 hour urine collection, defined by a UPCR of ≥1.5 mg/mg assessed in a first morning void urine specimen).

You may not qualify if:

• Estimated glomerular filtration rate (eGFR) as calculated by the Chronic Kidney Disease Epidemiology Collaboration equation of ≤45 mL/min/1.73 m2 at screening
• 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.
• Malignancy within 5 years of screening, with the exception of basal and squamous cell carcinomas treated by complete excision. Subjects with cervical dysplasia that is cervical intraepithelial neoplasia 1, but have been treated with conization or loop electrosurgical excision procedure, and have had a normal repeat Papanicolaou smear test (PAP) are allowed.
• Lymphoproliferative disease or previous total lymphoid irradiation.
• Severe viral infection (such as Cytomegalovirus (CMV), Hepatitis B virus (HBV), Hepatitis C virus (HCV)) within 3 months of screening; or known human immunodeficiency virus infection.
• Active tuberculosis (TB), or known history of TB/evidence of old TB if not taking prophylaxis with isoniazid.
• Other known clinically significant active medical conditions, such as:
• Liver dysfunction (aspartate aminotransferase, alanine aminotransferase, or bilirubin greater than 2.5 times the upper limit of normal) at screening and confirmed before enrollment.
• Chronic obstructive pulmonary disease or asthma requiring oral steroids.
• Bone marrow insufficiency unrelated to active systemic lupus erythematosus (SLE) (according to Investigator judgment) with white blood cell count \<2,500/mm3; absolute neutrophil count \<1.3 × 103/μL; thrombocytopenia (platelet count \<50,000/mm3).
• Active bleeding disorders.
• Current infection requiring IV antibiotics.

Sponsors & Collaborators

• Aurinia Pharmaceuticals Inc.: lead

Study Sites (2)

AURION Site

Kuala Lumpur, 50586, Malaysia

Location

AURION Site

Kuala Lumpur, 56000, Malaysia

Location

MeSH Terms

Conditions

Lupus Nephritis

Interventions

voclosporin

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Rashieda Gluck
• Organization: Aurinia Pharmaceuticals

clinicaltrials@auriniapharma.com

1 (250) 744-2487

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2016
• First Posted: October 31, 2016
• Study Start: June 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: February 17, 2017
• Last Updated: March 19, 2021
• Results First Posted: March 19, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

MY (2)