Trial Outcomes & Findings for Aurinia Early Urinary Protein Reduction Predicts Response (NCT NCT02949973)
NCT ID: NCT02949973
Last Updated: 2021-03-19
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
24 weeks
Results posted on
2021-03-19
Participant Flow
Participant milestones
| Measure |
Voclosporin 23.7 mg Twice Daily (BID) in Combination With Standard of Care
Voclosporin 23.7 mg twice daily (BID)
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Voclosporin 23.7 mg Twice Daily (BID) in Combination With Standard of Care
Voclosporin 23.7 mg twice daily (BID)
|
|---|---|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
Aurinia Early Urinary Protein Reduction Predicts Response
Baseline characteristics by cohort
| Measure |
Voclosporin 23.7 mg Twice Daily (BID) in Combination With Standard of Care
n=10 Participants
Voclosporin 23.7 mg Twice Daily (BID)
|
|---|---|
|
Age, Continuous
|
28.7 years
STANDARD_DEVIATION 5.14 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Malaysia
|
10 Participants
n=5 Participants
|
|
Duration of systemic lupus erythematosus, proteinuria and lupus nephritis
Duration of systemic lupus erythematosus (SLE)
|
7.3 years
STANDARD_DEVIATION 3.23 • n=5 Participants
|
|
Duration of systemic lupus erythematosus, proteinuria and lupus nephritis
Duration of proteinuria
|
5.9 years
STANDARD_DEVIATION 3.38 • n=5 Participants
|
|
Duration of systemic lupus erythematosus, proteinuria and lupus nephritis
Duration of Lupus Nephritis (LN)
|
5.8 years
STANDARD_DEVIATION 3.49 • n=5 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: Safety Population
Outcome measures
| Measure |
Voclosporin 23.7 mg Twice Daily (BID) in Combination With Standard of Care
n=10 Participants
Voclosporin 23.7 mg Twice Daily (BID)
|
|---|---|
|
Number of Participants With Reduction or Normalization of Urine Protein/Creatinine Ratio (UPCR)
|
7 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: Safety Population
Outcome measures
| Measure |
Voclosporin 23.7 mg Twice Daily (BID) in Combination With Standard of Care
n=10 Participants
Voclosporin 23.7 mg Twice Daily (BID)
|
|---|---|
|
Number of Participants With Reduction or Normalization of Anti ds DNA
|
4 Participants
|
PRIMARY outcome
Timeframe: 24 weeksOutcome measures
| Measure |
Voclosporin 23.7 mg Twice Daily (BID) in Combination With Standard of Care
n=10 Participants
Voclosporin 23.7 mg Twice Daily (BID)
|
|---|---|
|
Number of Participants With Reduction or Normalization of C3
|
2 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: Safety Population
Outcome measures
| Measure |
Voclosporin 23.7 mg Twice Daily (BID) in Combination With Standard of Care
n=10 Participants
Voclosporin 23.7 mg Twice Daily (BID)
|
|---|---|
|
Number of Participants With Reduction or Normalization of C4
|
2 Participants
|
SECONDARY outcome
Timeframe: week 24Population: Safety Population
* Confirmed Protein/creatinine ratio of ≤0.5 mg/mg and * eGFR ≥ 60 mL/min/1.73 m2 or no confirmed decrease from baseline in eGFR of ≥20%
Outcome measures
| Measure |
Voclosporin 23.7 mg Twice Daily (BID) in Combination With Standard of Care
n=10 Participants
Voclosporin 23.7 mg Twice Daily (BID)
|
|---|---|
|
Number of Participants With Complete Remission at Week 24
|
7 Participants
|
SECONDARY outcome
Timeframe: week 48Population: Safety Population
* Confirmed Protein/creatinine ratio of ≤0.5 mg/mg and * eGFR ≥ 60 mL/min/1.73 m2 or no confirmed decrease from baseline in eGFR of ≥20% Safety Population - 2 subjects failed to provide sufficient data to ascertain week 48 response
Outcome measures
| Measure |
Voclosporin 23.7 mg Twice Daily (BID) in Combination With Standard of Care
n=8 Participants
Voclosporin 23.7 mg Twice Daily (BID)
|
|---|---|
|
Number of Participants With Complete Remission at Week 48
|
4 Participants
|
Adverse Events
Voclosporin 23.7 mg Twice Daily (BID) in Combination With Standard of Care
Serious events: 3 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Voclosporin 23.7 mg Twice Daily (BID) in Combination With Standard of Care
n=10 participants at risk
Voclosporin 23.7 mg Twice Daily (BID)
|
|---|---|
|
Infections and infestations
Acute Tonsilitis
|
10.0%
1/10 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
10.0%
1/10 • Number of events 1
|
|
Blood and lymphatic system disorders
Anaemia
|
10.0%
1/10 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Pyrexia
|
10.0%
1/10 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
10.0%
1/10 • Number of events 1
|
Other adverse events
| Measure |
Voclosporin 23.7 mg Twice Daily (BID) in Combination With Standard of Care
n=10 participants at risk
Voclosporin 23.7 mg Twice Daily (BID)
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
10.0%
1/10 • Number of events 1
|
|
Cardiac disorders
Palpitations
|
10.0%
1/10 • Number of events 1
|
|
Ear and labyrinth disorders
Otorrhoea
|
10.0%
1/10 • Number of events 2
|
|
Endocrine disorders
Cushingoid
|
10.0%
1/10 • Number of events 1
|
|
Eye disorders
Chalazion
|
10.0%
1/10 • Number of events 1
|
|
Eye disorders
Conjunctival Haemorrhage
|
10.0%
1/10 • Number of events 1
|
|
Eye disorders
Eyelid Oedema
|
10.0%
1/10 • Number of events 1
|
|
Eye disorders
Vision Blurred
|
20.0%
2/10 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhoea
|
40.0%
4/10 • Number of events 6
|
|
Gastrointestinal disorders
Dyspepsia
|
20.0%
2/10 • Number of events 2
|
|
Gastrointestinal disorders
Gingival Bleeding
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Gingival Pain
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Gingival Swelling
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Tongue Ulceration
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Toothache
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Chest Pain
|
20.0%
2/10 • Number of events 2
|
|
General disorders
Local Swelling
|
20.0%
2/10 • Number of events 2
|
|
General disorders
Oedema
|
20.0%
2/10 • Number of events 2
|
|
General disorders
Oedema Peripheral
|
10.0%
1/10 • Number of events 2
|
|
General disorders
Pyrexia
|
50.0%
5/10 • Number of events 10
|
|
Infections and infestations
Herpes Zoster
|
10.0%
1/10 • Number of events 1
|
|
Infections and infestations
Nasopharyngitis
|
20.0%
2/10 • Number of events 2
|
|
Infections and infestations
Tonsillitis
|
10.0%
1/10 • Number of events 1
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
50.0%
5/10 • Number of events 7
|
|
Infections and infestations
Urinary Tract Infection
|
10.0%
1/10 • Number of events 1
|
|
Infections and infestations
Viral Pharyngitis
|
10.0%
1/10 • Number of events 1
|
|
Investigations
Breath Sounds Abnormal
|
10.0%
1/10 • Number of events 1
|
|
Investigations
Glomerular Filtration Rate Decreased
|
40.0%
4/10 • Number of events 4
|
|
Metabolism and nutrition disorders
Dehydration
|
10.0%
1/10 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.0%
2/10 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
10.0%
1/10 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
1/10 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Joint Effusion
|
10.0%
1/10 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
10.0%
1/10 • Number of events 1
|
|
Nervous system disorders
Burning Sensation
|
10.0%
1/10 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
20.0%
2/10 • Number of events 3
|
|
Nervous system disorders
Headache
|
10.0%
1/10 • Number of events 1
|
|
Nervous system disorders
Lethargy
|
10.0%
1/10 • Number of events 1
|
|
Nervous system disorders
Tremor
|
10.0%
1/10 • Number of events 1
|
|
Renal and urinary disorders
Renal Failure Acute
|
10.0%
1/10 • Number of events 1
|
|
Reproductive system and breast disorders
Menstruation Irregular
|
10.0%
1/10 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
30.0%
3/10 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
10.0%
1/10 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
10.0%
1/10 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Eczema
|
10.0%
1/10 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hirsutism
|
10.0%
1/10 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Photosensitivity Reaction
|
10.0%
1/10 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash Macular
|
10.0%
1/10 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash Papular
|
10.0%
1/10 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Swelling Face
|
10.0%
1/10 • Number of events 1
|
|
Vascular disorders
Hypertension
|
40.0%
4/10 • Number of events 8
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place