LUPUS NEPHRITIS CLINICAL STUDY
About the AURORA Clinical Study
What to expect during study visits
If you agree to take part in AURORA
You may qualify for the AURORA study if you... (select any that apply)
Have not had a kidney transplant
Are not on renal dialysis
Are currently taking corticosteroids
Have a diagnosis of Systemic Lupus Erythematosus (SLE)
Are spilling protein in your urine
Have had a previous Kidney biopsy
About Lupus Nephritis
Voclosporin, an investigational drug, is being developed by Aurinia Pharmaceuticals Inc. for the potential treatment of lupus nephritis. Voclosporin is not commercially available and is not approved for use by any national or foreign drug regulatory authority as safe or effective for any treatment, including Lupus Nephritis. Voclosporin belongs to a class of medications called immunosuppressants. Studies in people and animals have shown voclosporin has the potential to work in a similar manner as other approved immunosuppressants, but at possibly a lower dose with fewer side effects. Approximately 2,400 people have taken voclosporin or other investigational products containing voclosporin in clinical trials.
A phase 2 clinical trial to examine the use of voclosporin in achieving complete remission in patients with active lupus nephritis was recently completed. In the trial, 49% of the patients receiving low dose (23.7 mg twice daily) voclosporin achieved complete clinical remission after 48 weeks of treatment.
Lupus nephritis is kidney inflammation caused by systemic lupus erythematosus (SLE or lupus). SLE is an autoimmune disease—a disorder in which the body’s immune system attacks its own tissues causing damage. Up to 60 percent of people with SLE are diagnosed with lupus nephritis, which can lead to significant illness and even death.*
Aurinia is a clinical stage biopharmaceutical company focused on developing and commercializing therapies to treat targeted patient populations that are suffering from serious diseases with a high unmet medical need. The company is currently developing voclosporin, an investigational drug, for the treatment of LN. The company is headquartered in Victoria, BC and focuses its development efforts globally.
*Lee YH, Woo JH, Choi SJ, Ji JD, Song GG. Induction and maintenance therapy for lupus nephritis: a systematic review and meta-analysis. Lupus. 2010;19:703–710
Participants will be randomized to receive either the investigational drug voclosporin (23.7 mg twice daily) or placebo as a study drug. Neither participant nor the study doctor will know if you are taking voclosporin or placebo during the study. Participants will also receive standard medication mycophenolate mofetil (e.g. Cellcept®) and steroids in addition to the study drug for the duration of the study.
Participants will receive study medication for approximately 12 months and participants are expected to attend about 16 clinic visits over the course of the study period. Study assessments, study drugs and procedures will be provided at no cost to participants.
Approximately 324 participants with biopsy confirmed lupus nephritis will be enrolled in this study at multiple sites around the world.
© Aurinia Pharmaceuticals Inc.
For more information on this study and/or to find study site locations, please contact us.
You may qualify for AURORA. For more information and/or to find study site locations, please contact us.
Lupus nephritis is kidney inflammation caused by systemic lupus erythematosus (SLE or lupus). SLE is an autoimmune disease—a disorder in which the body’s immune system attacks its own tissues causing damage. Up to 60 percent of people with SLE are diagnosed with lupus nephritis, which can lead to significant illness and even death.**Lee YH, Woo JH, Choi SJ, Ji JD, Song GG. Induction and maintenance therapy for lupus nephritis: a systematic review and meta-analysis. Lupus. 2010;19:703–710
Kidney damage from lupus can be mild or severe. It can cause damage to the filtering units (glomeruli) of the kidney. Since these filtering units clear your blood of waste, damage to them can cause your kidneys to work poorly or not at all. About 90 percent of lupus patients will have some kidney damage. However, the kidney disease may be "silent" and not cause any symptoms. Symptoms of Lupus Nephritis may include; high blood pressure, swelling of the legs and body, weight gain, dark urine or blood in the urine.
Urinalysis: Urinalysis is testing of a urine sample. The urine sample is collected in a special container in a doctor's office and can be tested in the same location or sent to a lab for analysis. A high number of red blood cells or high levels of protein in the urine indicate kidney damage.
Blood Test: A blood test involves drawing blood at a doctor’s office and sending the sample to a lab for analysis. The blood test can show high levels of creatinine, a waste product of normal muscle breakdown excreted by the kidneys, which increases when the kidneys are not functioning well.
Biopsy: A biopsy is a procedure that involves taking a small piece of kidney tissue for examination with a microscope. A kidney biopsy is done in a hospital under local anesthesia. While you lie on your stomach the doctor will insert a very thin, long needle through the skin of your back and remove a tiny piece of tissue from one of your kidneys. The tissue will be examined under a microscope to determine how much inflammation or scarring is present The American College of Rheumatology recommends biopsies for all people with evidence of active lupus nephritis that has not been previously treated.
Lupus nephritis is kidney inflammation caused by systemic lupus erythematosus (SLE or lupus)
Lupus nephritis is diagnosed through urine and blood tests and a kidney biopsy.
Lupus nephritis is treated with medications that suppress the immune system, so it stops attacking and damaging the kidneys. Examples include IV cyclophosphamide or mycophenolate mofetil, typically used with prednisone.
a complete physical examination and review of your medical history
assessment of your lupus activity
vital signs (blood pressure, heart rate and respiration rate)
electrocardiogram (ECG: an electrical recording of the activity of the heart)
review of your health status and / or other medications that you are taking
come to ALL scheduled visits
give complete and accurate information about your medical history
not take part in any other clinical research during this study and for a minimum of 30 days after completing the study
not give blood during the study and for at least 30 days following the last blood draw of the study
follow all study instructions
tell your study doctor about any medical appointments or tests outside of the study (i.e., the dentist, family doctor, etc.);
tell your study doctor about any changes in your medical condition during the study and for 30 days after completing the study.