Aurinia Early Urinary Protein Reduction Predicts Response

• Register: ClinicalTrials.gov
• Last refreshed on: 29 March 2021
• Main ID: NCT02949973
• Date of registration: 26/10/2016
• Prospective Registration: No
• Primary sponsor: Aurinia Pharmaceuticals Inc.
• Public title: Aurinia Early Urinary Protein Reduction Predicts Response AURION
• Scientific title: An Exploratory Study Assessing the Short Term Predictors of Remission of Voclosporin 23.7mg Twice Daily (BID) in Combination With Standard of Care in Patients With Active Lupus Nephritis
• Date of first enrolment: June 2015
• Target sample size: 10
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02949973
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Malaysia

Key inclusion & exclusion criteria

Key Inclusion Criteria:

- 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).

Key Exclusion Criteria:

- 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:

- Severe cardiovascular disease including congestive heart failure, history of cardiac
dysrhythmia or congenital long QT syndrome. QT interval duration corrected for heart
rate using method of Fridericia (QTcF) exceeding 480 msec in the presence of a normal
QRS interval (<110 msec) at time of screening will result in exclusion.

- 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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Lupus Nephritis

Intervention(s)

Drug: voclosporin

Primary Outcome(s)

Number of Participants With Reduction or Normalization of C4 [Time Frame: 24 weeks]

Number of Participants With Reduction or Normalization of Anti ds DNA [Time Frame: 24 weeks]

Number of Participants With Reduction or Normalization of Urine Protein/Creatinine Ratio (UPCR) [Time Frame: 24 weeks]

Number of Participants With Reduction or Normalization of C3 [Time Frame: 24 weeks]

Secondary Outcome(s)

Number of Participants With Complete Remission at Week 24 [Time Frame: week 24]

Number of Participants With Complete Remission at Week 48 [Time Frame: week 48]

Secondary ID(s)

AUR-VCS-2014-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 19/03/2021
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02949973