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The purpose of this study is assess the long-term safety and tolerability of voclosporin compared with placebo for up to an additional 24 months following completion of treatment in the AURORA 1 study in subjects with lupus nephritis (LN).
The aim of the Phase 3 continuation study (AURORA 2) is to assess the long-term safety and tolerability of voclosporin, added to the standard of care treatment in LN, for an additional 24 months, following a treatment period of 52 weeks in the AURORA 1 study (AUR-VCS-2016-01). All subjects will continue to receive background therapy of mycophenolate mofetil (MMF) and/or oral corticosteroids starting at the same dose as at the end of the AURORA 1 study. Subjects with LN, who have completed 52 weeks of treatment with study drug in the AURORA 1 study, will be eligible to enter the study. The long-term safety and tolerability of the drug combination will be assessed from its safety profile while demonstrating the continued ability to achieve and maintain long-term renal response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Voclosporin | Experimental | Voclosporin |
|
| Placebo Oral Capsule | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Voclosporin | Drug | Calcineurin inhibitor, oral, 23.7 mg twice daily (BID) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events (AE) Profile and Routine Biochemical and Hematological Assessments. | Number (and percent) of adverse events experienced during the AURORA 2 treatment period. To assess the long-term safety and tolerability of voclosporin compared with placebo for up to an additional 24 months following completion of treatment in the AURORA 1 study in subjects with LN. | Month 12 (AURORA 2 baseline) to Month 36 |
| Measure | Description | Time Frame |
|---|---|---|
| Number (and Percent) of Subjects in Renal Response | Proportion of subjects in renal response defined as:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AURORA Investigative Center | Oklahoma City | Oklahoma | 73104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22879439 | Background | Rovin BH, Parikh SV, Hebert LA, Chan TM, Mok CC, Ginzler EM, Hooi LS, Brunetta P, Maciuca R, Solomons N. Lupus nephritis: induction therapy in severe lupus nephritis--should MMF be considered the drug of choice? Clin J Am Soc Nephrol. 2013 Jan;8(1):147-53. doi: 10.2215/CJN.03290412. Epub 2012 Aug 9. | |
| 22087680 | Background |
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| ID | Title | Description |
|---|---|---|
| FG000 | Voclosporin | Voclosporin 23.7 mg twice daily (BID) + Mycophenolate Mofetil + corticosteroid |
| FG001 | Placebo Oral Capsule | Placebo 23.7 mg twice daily (BID) + Mycophenolate Mofetil + corticosteroid |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Intent-to-Treat is comprised of all subjects who were randomized treatment during AURORA 1 AND who consented to continue their treatment in AURORA 2. Baseline values were collected at the start of AURORA 1 but only for subjects that continued in AURORA 2. Intent-to-Treat population was used for analysis of all Outcome Measures. Safety population comprised all randomized subjects who took at least one dose of study treatment, and was used for AE and SAE reporting.
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| ID | Title | Description |
|---|---|---|
| BG000 | Voclosporin | Voclosporin 23.7 mg twice daily (BID) + Mycophenolate Mofetil (MMF) + corticosteroid |
| BG001 | Placebo Oral Capsule | Placebo 23.7 mg twice daily (BID) + Mycophenolate Mofetil (MMF) + corticosteroid |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Adverse Events (AE) Profile and Routine Biochemical and Hematological Assessments. | Number (and percent) of adverse events experienced during the AURORA 2 treatment period. To assess the long-term safety and tolerability of voclosporin compared with placebo for up to an additional 24 months following completion of treatment in the AURORA 1 study in subjects with LN. | Posted | Count of Participants | Participants | Month 12 (AURORA 2 baseline) to Month 36 |
|
Treatment-emergent adverse events (TEAEs) are events occurring from Month 12 of treatment (AURORA 2 baseline) up to 30 days after study treatment end in AURORA 2 (Month 37).
Subjects are counted once within a system organ class and once for each unique preferred term.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Voclosporin | Voclosporin Voclosporin: Calcineurin inhibitor, oral, 23.7 mg BID |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Corona virus infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Information | Aurinia Pharmaceuticals | 1 (250) 744-2487 | clinicaltrials@auriniapharma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: Protocol v1.0 | Oct 13, 2017 | Sep 26, 2022 | Prot_000.pdf |
| Prot | Yes | No | No | Study Protocol: Protocol v2.0 | Oct 10, 2018 | Sep 26, 2022 | Prot_001.pdf |
| Prot | Yes | No | No | Study Protocol: Protocol v3.0 | Dec 21, 2018 | Sep 26, 2022 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 11, 2021 | Sep 26, 2022 | SAP_003.pdf |
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| ID | Term |
|---|---|
| D008181 | Lupus Nephritis |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| C484071 | voclosporin |
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| Placebo Oral Capsule | Drug | Voclosporin placebo, oral, 3 capsules twice daily (BID) |
|
| Months 12 (AURORA 2 Baseline), 18, 24, 30 and 36 |
| Number (and Percent) of Subjects in Partial Renal Response | Partial renal response defined as a 50% reduction from baseline in urine protein creatinine ratio (UPCR). | Months 12 (AURORA 2 baseline), 18, 24, 30 and 36 |
| Renal Flare as Adjudicated by the Clinical Endpoints Committee (CEC). | A patient could experience a flare from the point they achieved a response (or recovery). Renal flares were judged according to the following criteria:
| Month 12 (AURORA 2 baseline) to Month 36 |
| Change From AURORA 1 Baseline (i.e., Month 0) in Safety of Estrogens in Lupus Erythematosus National Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) | Participants analyzed included all subjects who were randomized treatment during AURORA 1 AND who consented to continue their treatment in AURORA 2. Baseline values were collected at the start of AURORA 1 but only for those subjects that continued in AURORA 2. Assessment of Systemic Lupus Erythematosus (SLE) Disease Activity within the last 10 days. It scores 24 disease descriptors across 9 organ systems which are summed to a minimum of <2 (considered indicative of no activity) and maximum of 105 points. Scores are weighted and a score of 6 is considered clinically significant. Higher scores indicate worse disease activity. | Months 18, 24 and 36 |
| Change From AURORA 1 Baseline (i.e., Month 0) in Urine Protein to Creatinine Ratio (UPCR) | Participants analyzed included all subjects who were randomized treatment during AURORA 1 AND who consented to continue their treatment in AURORA 2. Baseline values were collected at the start of AURORA 1 but only for those subjects that continued in AURORA 2. Reductions in UPCR are indicative of better renal outcomes. | Months 12 (AURORA 2 baseline), 18, 24, 30 and 36 |
| Change From AURORA 1 Baseline (i.e., Month 0) in Estimated Glomerular Filtration Rate (eGFR) | Participants analyzed included all subjects who were randomized treatment during AURORA 1 AND who consented to continue their treatment in AURORA 2. Baseline values were collected at the start of AURORA 1 but only for those subjects that continued in AURORA 2. This endpoint incorporated Corrected eGFR values with a ceiling set to 90 mL/min/1.73 m^2 Increases in eGFR levels are indicative of better renal outcomes. | Months 12 (AURORA 2 baseline), 18, 24, 30 and 36 |
| Change From AURORA 1 Baseline (i.e., Month 0) in Urine Protein | Participants analyzed included all subjects who were randomized treatment during AURORA 1 AND who consented to continue their treatment in AURORA 2. Baseline values were collected at the start of AURORA 1 but only for those subjects that continued in AURORA 2. Reductions in Urine Protein levels are indicative of better renal outcomes. | Months 12 (AURORA 2 baseline), 18, 24, 30 and 36 |
| Change From AURORA 1 Baseline (i.e., Month 0) in Serum Creatinine (SCr) | Participants analyzed included all subjects who were randomized treatment during AURORA 1 AND who consented to continue their treatment in AURORA 2. Baseline values were collected at the start of AURORA 1 but only for those subjects that continued in AURORA 2. Decreases in SCr levels can be indicative of better renal outcomes. | Months 12 (AURORA 2 baseline), 18, 24, 30 and 36 |
| Dooley MA, Jayne D, Ginzler EM, Isenberg D, Olsen NJ, Wofsy D, Eitner F, Appel GB, Contreras G, Lisk L, Solomons N; ALMS Group. Mycophenolate versus azathioprine as maintenance therapy for lupus nephritis. N Engl J Med. 2011 Nov 17;365(20):1886-95. doi: 10.1056/NEJMoa1014460. |
| 24330024 | Background | Ling SY, Huizinga RB, Mayo PR, Larouche R, Freitag DG, Aspeslet LJ, Foster RT. Cytochrome P450 3A and P-glycoprotein drug-drug interactions with voclosporin. Br J Clin Pharmacol. 2014 Jun;77(6):1039-50. doi: 10.1111/bcp.12309. |
| 23996158 | Background | Ling SY, Huizinga RB, Mayo PR, Freitag DG, Aspeslet LJ, Foster RT. Pharmacokinetics of voclosporin in renal impairment and hepatic impairment. J Clin Pharmacol. 2013 Dec;53(12):1303-12. doi: 10.1002/jcph.166. Epub 2013 Oct 8. |
| 23736966 | Background | Mayo PR, Huizinga RB, Ling SY, Freitag DG, Aspeslet LJ, Foster RT. Voclosporin food effect and single oral ascending dose pharmacokinetic and pharmacodynamic studies in healthy human subjects. J Clin Pharmacol. 2013 Aug;53(8):819-26. doi: 10.1002/jcph.114. Epub 2013 Jun 4. |
| 21943027 | Background | Busque S, Cantarovich M, Mulgaonkar S, Gaston R, Gaber AO, Mayo PR, Ling S, Huizinga RB, Meier-Kriesche HU; PROMISE Investigators. The PROMISE study: a phase 2b multicenter study of voclosporin (ISA247) versus tacrolimus in de novo kidney transplantation. Am J Transplant. 2011 Dec;11(12):2675-84. doi: 10.1111/j.1600-6143.2011.03763.x. Epub 2011 Sep 22. |
| 37528520 | Derived | Avasare R, Drexler Y, Caster DJ, Mitrofanova A, Jefferson JA. Management of Lupus Nephritis: New Treatments and Updated Guidelines. Kidney360. 2023 Oct 1;4(10):1503-1511. doi: 10.34067/KID.0000000000000230. |
| Pregnancy |
|
| Lack of Efficacy |
|
| Physician Decision |
|
| Protocol Violation |
|
| Adverse Event |
|
| Death |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Southeast Asia ("Asia Pacific") includes Japan, Malaysia, Philippines, Thailand, Taiwan & Vietnam. Europe ("Europe") includes Belarus, Croatia, Netherlands, Russia, Serbia, Spain, Turkey, Ukraine as well as South Africa. South America ("Latin America") includes Argentina, Brazil, Chile, Colombia, Dominican Republic, Guatemala, Mexico & Peru. | Number | participants |
|
| Lupus Nephritis (LN) history | Number of years since diagnosis of systemic lupus erythematosus (SLE), lupus nephritis (LN) and first significant proteinuria | Mean | Standard Deviation | years |
|
| Baseline Urine Protein Creatinine Ratio (UPCR) | Baseline Urine Protein Creatinine Ratio (UPCR) (Average of pre-randomisation values) | Mean | Standard Deviation | mg/mg |
|
| Baseline estimated glomerular filtration rate (eGFR) | Baseline estimated Glomerular Filtration Rate Chronic Kidney Disease Epidemiology Collaboration (CKD-Epi formula) (lowest pre-randomisation value) | Mean | Standard Deviation | mL/min/1.73 m^2 |
|
|
|
| Secondary | Number (and Percent) of Subjects in Renal Response | Proportion of subjects in renal response defined as:
| Posted | Count of Participants | Participants | Months 12 (AURORA 2 Baseline), 18, 24, 30 and 36 |
|
|
|
|
| Secondary | Number (and Percent) of Subjects in Partial Renal Response | Partial renal response defined as a 50% reduction from baseline in urine protein creatinine ratio (UPCR). | Posted | Count of Participants | Participants | Months 12 (AURORA 2 baseline), 18, 24, 30 and 36 |
|
|
|
|
| Secondary | Renal Flare as Adjudicated by the Clinical Endpoints Committee (CEC). | A patient could experience a flare from the point they achieved a response (or recovery). Renal flares were judged according to the following criteria:
| Posted | Count of Participants | Participants | Month 12 (AURORA 2 baseline) to Month 36 |
|
|
|
|
| Secondary | Change From AURORA 1 Baseline (i.e., Month 0) in Safety of Estrogens in Lupus Erythematosus National Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) | Participants analyzed included all subjects who were randomized treatment during AURORA 1 AND who consented to continue their treatment in AURORA 2. Baseline values were collected at the start of AURORA 1 but only for those subjects that continued in AURORA 2. Assessment of Systemic Lupus Erythematosus (SLE) Disease Activity within the last 10 days. It scores 24 disease descriptors across 9 organ systems which are summed to a minimum of <2 (considered indicative of no activity) and maximum of 105 points. Scores are weighted and a score of 6 is considered clinically significant. Higher scores indicate worse disease activity. | The number of subjects analyzed may not be aligned with overall number analyzed due to subjects withdrawing from study and missed study visits | Posted | Least Squares Mean | 95% Confidence Interval | Scores on a scale | Months 18, 24 and 36 |
|
|
|
|
| Secondary | Change From AURORA 1 Baseline (i.e., Month 0) in Urine Protein to Creatinine Ratio (UPCR) | Participants analyzed included all subjects who were randomized treatment during AURORA 1 AND who consented to continue their treatment in AURORA 2. Baseline values were collected at the start of AURORA 1 but only for those subjects that continued in AURORA 2. Reductions in UPCR are indicative of better renal outcomes. | The number of subjects analyzed may not be aligned with overall number analyzed due to early withdrawals from study and missed study visits | Posted | Least Squares Mean | Standard Error | mg/mg | Months 12 (AURORA 2 baseline), 18, 24, 30 and 36 |
|
|
|
|
| Secondary | Change From AURORA 1 Baseline (i.e., Month 0) in Estimated Glomerular Filtration Rate (eGFR) | Participants analyzed included all subjects who were randomized treatment during AURORA 1 AND who consented to continue their treatment in AURORA 2. Baseline values were collected at the start of AURORA 1 but only for those subjects that continued in AURORA 2. This endpoint incorporated Corrected eGFR values with a ceiling set to 90 mL/min/1.73 m^2 Increases in eGFR levels are indicative of better renal outcomes. | The number of subjects analyzed may not be aligned with overall number analyzed due to early withdrawals from study and missed study visits | Posted | Least Squares Mean | Standard Error | mL/min/1.73 m^2 | Months 12 (AURORA 2 baseline), 18, 24, 30 and 36 |
|
|
|
|
| Secondary | Change From AURORA 1 Baseline (i.e., Month 0) in Urine Protein | Participants analyzed included all subjects who were randomized treatment during AURORA 1 AND who consented to continue their treatment in AURORA 2. Baseline values were collected at the start of AURORA 1 but only for those subjects that continued in AURORA 2. Reductions in Urine Protein levels are indicative of better renal outcomes. | The number of subjects analyzed may not be aligned with overall number analyzed due to early withdrawals from study and missed study visits | Posted | Least Squares Mean | Standard Error | mg/dL | Months 12 (AURORA 2 baseline), 18, 24, 30 and 36 |
|
|
|
|
| Secondary | Change From AURORA 1 Baseline (i.e., Month 0) in Serum Creatinine (SCr) | Participants analyzed included all subjects who were randomized treatment during AURORA 1 AND who consented to continue their treatment in AURORA 2. Baseline values were collected at the start of AURORA 1 but only for those subjects that continued in AURORA 2. Decreases in SCr levels can be indicative of better renal outcomes. | The number of subjects analyzed may not be aligned with overall number analyzed due to early withdrawals from study and missed study visits | Posted | Least Squares Mean | Standard Error | mg/dL | Months 12 (AURORA 2 baseline), 18, 24, 30 and 36 |
|
|
|
|
| 0 |
| 116 |
| 21 |
| 116 |
| 84 |
| 116 |
| EG001 | Placebo Oral Capsule | Placebo Placebo Oral Capsule: Voclosporin placebo, oral, 3 capsules BID | 3 | 100 | 23 | 100 | 60 | 100 |
| Urinary tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Pneumonia viral | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Disseminated tuberculosis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Lupus nephritis | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
|
| Systemic lupus erythematosus | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
|
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
|
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
|
| Nephropathy toxic | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
|
| Nephrotic syndrome | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA 20.0 | Systematic Assessment |
|
| Malignant glaucoma | Eye disorders | MedDRA 20.0 | Systematic Assessment |
|
| Hepatitis toxic | Hepatobiliary disorders | MedDRA 20.0 | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 20.0 | Systematic Assessment |
|
| Pericarditis lupus | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Glomerular filtration rate decreased | Investigations | MedDRA 20.0 | Systematic Assessment |
|
| Endometriosis | Reproductive system and breast disorders | MedDRA 20.0 | Systematic Assessment |
|
| Abortion induced | Surgical and medical procedures | MedDRA 20.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
|
| Venous thrombosis limb | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Corona virus infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Systemic lupus erythematosus | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Lupus nephritis | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Glomerular filtration rate decreased | Investigations | MedDRA 20.0 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 20.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA 20.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
|
Not provided
Not provided
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D008180 | Lupus Erythematosus, Systemic |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| Renal Response - Month 24 |
|
| Renal Response - Month 30 |
|
| Renal Response - Month 36 |
|
Month 18 |
| Regression, Logistic |
| 0.006 |
| Odds Ratio (OR) |
| 2.19 |
| 2-Sided |
| 95 |
| 1.25 |
| 3.83 |
| Other |
The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and region. Subjects who withdrew from the study prior to the visit assessments and thus provide insufficient visit data were defined as non-responders. |
| Month 24 | Regression, Logistic | 0.035 | Odds Ratio (OR) | 1.81 | 2-Sided | 95 | 1.04 | 3.16 | Other | The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and region. Subjects who withdrew from the study prior to the visit assessments and thus provide insufficient visit data were defined as non-responders. |
| Month 30 | Regression, Logistic | 0.005 | Odds Ratio (OR) | 2.24 | 2-Sided | 95 | 1.28 | 3.92 | Other | The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and region. Subjects who withdrew from the study prior to the visit assessments and thus provide insufficient visit data were defined as non-responders. |
| Month 36 | Regression, Logistic | 0.051 | Odds Ratio (OR) | 1.74 | 2-Sided | 95 | 1.00 | 3.03 | Other | The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and region. Subjects who withdrew from the study prior to the visit assessments and thus provide insufficient visit data were defined as non-responders. |
| Partial Renal Response - Month 24 |
|
| Partial Renal Response - Month 30 |
|
| Partial Renal Response - Month 36 |
|
Month 18 |
| Regression, Logistic |
| 0.008 |
| Odds Ratio (OR) |
| 2.50 |
| 2-Sided |
| 95 |
| 1.28 |
| 4.88 |
| Other |
The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and region. Subjects who withdrew from the study prior to the visit assessments and thus provide insufficient visit data were defined as non-responders. |
| Month 24 | Regression, Logistic | 0.001 | Odds Ratio (OR) | 2.68 | 2-Sided | 95 | 1.46 | 4.91 | Other | The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and region. Subjects who withdrew from the study prior to the visit assessments and thus provide insufficient visit data were defined as non-responders. |
| Month 30 | Regression, Logistic | 0.040 | Odds Ratio (OR) | 1.86 | 2-Sided | 95 | 1.03 | 3.34 | Other | The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and region. Subjects who withdrew from the study prior to the visit assessments and thus provide insufficient visit data were defined as non-responders. |
| Month 36 | Regression, Logistic | 0.290 | Odds Ratio (OR) | 1.39 | 2-Sided | 95 | 0.75 | 2.58 | Other | The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and region. Subjects who withdrew from the study prior to the visit assessments and thus provide insufficient visit data were defined as non-responders. |
| Month 24 |
|
|
| Month 36 |
|
|
| 0.215 |
| Least Squares Mean difference |
| -0.7 |
| 2-Sided |
| 95 |
| -1.8 |
| 0.4 |
| Superiority |
| Month 36 | Mixed Models Analysis | 0.246 | Least Squares Mean difference | -0.7 | 2-Sided | 95 | -1.8 | 0.5 | Superiority |
| Month 18 |
|
|
| Month 24 |
|
|
| Month 30 |
|
|
| Month 36 |
|
|
| 0.029 |
| Least Squares Mean difference |
| -0.63 |
| 2-Sided |
| 95 |
| -1.20 |
| -0.07 |
| Superiority |
| Month 24 | Mixed Models Analysis | 0.002 | Least Squares Mean difference | -0.77 | 2-Sided | 95 | -1.24 | -0.29 | Superiority |
| Month 30 | Mixed Models Analysis | 0.002 | Least Squares Mean difference | -0.91 | 2-Sided | 95 | -1.49 | -0.33 | Superiority |
| Month 36 | Mixed Models Analysis | 0.106 | Least Squares Mean difference | -0.48 | 2-Sided | 95 | -1.06 | -0.10 | Superiority |
| Month 18 |
|
|
| Month 24 |
|
|
| Month 30 |
|
|
| Month 36 |
|
|
| 0.292 |
| Least Squares Mean difference |
| -1.8 |
| 2-Sided |
| 95 |
| -5.1 |
| 1.6 |
| Superiority |
| Month 24 | Mixed Models Analysis | 0.282 | Least Squares Mean difference | -2.2 | 2-Sided | 95 | -6.1 | 1.8 | Superiority |
| Month 30 | Mixed Models Analysis | 0.659 | Least Squares Mean difference | 0.9 | 2-Sided | 95 | -3.2 | 5.1 | Superiority |
| Month 36 | Mixed Models Analysis | 0.438 | Least Squares Mean difference | 1.8 | 2-Sided | 95 | -2.8 | 6.4 | Superiority |
| Month 18 |
|
|
| Month 24 |
|
|
| Month 30 |
|
|
| Month 36 |
|
|
| 0.007 |
| Least Squares Mean difference |
| -87.7 |
| 2-Sided |
| 95 |
| -151.2 |
| -24.2 |
| Superiority |
| Month 24 | Mixed Models Analysis | 0.035 | Least Squares Mean difference | -47.0 | 2-Sided | 95 | -90.8 | -3.3 | Superiority |
| Month 30 | Mixed Models Analysis | 0.005 | Least Squares Mean difference | -73.1 | 2-Sided | 95 | -123.5 | -22.6 | Superiority |
| Month 36 | Mixed Models Analysis | 0.537 | Least Squares Mean difference | -19.0 | 2-Sided | 95 | -79.7 | 41.7 | Superiority |
| Month 18 |
|
|
| Month 24 |
|
|
| Month 30 |
|
|
| Month 36 |
|
|
| 0.209 |
| Least Squares Mean difference |
| 0.051 |
| 2-Sided |
| 95 |
| -0.029 |
| 0.131 |
| Superiority |
| Month 24 | Mixed Models Analysis | 0.353 | Least Squares Mean difference | 0.057 | 2-Sided | 95 | -0.064 | 0.178 | Superiority |
| Month 30 | Mixed Models Analysis | 0.616 | Least Squares Mean difference | -0.036 | 2-Sided | 95 | -0.176 | 0.105 | Superiority |
| Month 36 | Mixed Models Analysis | 0.372 | Least Squares Mean difference | -0.077 | 2-Sided | 95 | -0.248 | 0.094 | Superiority |