Aurora trial pdf

Outcome Measures. Time in days to reduction in Urine Protein Creatinine Ratio to decrease to 0. Baseline UPCR is the average of 2 pre-randomisation values. Baseline is the average of two pre-randomisation values. Change from baseline by visit in estimated Glomerular Filtration rate. Change from baseline by visit in Urine Protein Creatinine Ratio. Eligibility Criteria. Biopsy results over 6 months prior to screening must be reviewed with a medical monitor to confirm eligibility.

Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline.

Current or medical history of: Congenital or acquired immunodeficiency. In the opinion of the Investigator, clinically significant drug or alcohol abuse within 2 years prior to screening.

Malignancy within 5 years of screening, with the exception of basal and squamous cell carcinomas treated by complete excision. Lymphoproliferative disease or previous total lymphoid irradiation. Severe viral infection or known HIV infection. Other known clinically significant active medical conditions, such as: Severe cardiovascular disease, liver dysfunction or chronic obstructive pulmonary disease or asthma requiring oral steroids or any other overlapping autoimmune condition for which the condition or the treatment of the condition may affect the study assessments or outcomes.

Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials. Study Protocol: Protocol V2. More Information. Mycophenolate versus azathioprine as maintenance therapy for lupus nephritis.

N Engl J Med. Am J Transplant. Forgot your user name or password? Search for this keyword. Advanced search. Log in via Institution. Email alerts. Article Text. Article menu. The disease is highly heterogeneous, affecting a wide range of organs and tissue systems. Unlike SLE, LN has straightforward disease outcomes measuring proteinuria where an early response correlates with long-term outcomes. Aurinia Pharmaceuticals is a late clinical-stage biopharmaceutical company focused on developing and commercializing therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need.

The Company is currently developing an investigational drug, for the treatment of lupus nephritis, focal segmental glomerulosclerosis and dry eye syndrome. For further information, see our website at www. Certain statements made in this press release may constitute forward-looking information within the meaning of applicable Canadian securities law and forward-looking statements within the meaning of applicable United States securities law.

It is possible that such results or conclusions may change based on further analyses of these data. Even though the management of Aurinia believes that the assumptions made, and the expectations represented by such statements or information are reasonable, there can be no assurance that the forward-looking information will prove to be accurate.

Forward-looking information by their nature are based on assumptions and involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aurinia to be materially different from any future results, performance or achievements expressed or implied by such forward-looking information. Should one or more of these risks and uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in forward-looking statements or information.

Such risks, uncertainties and other factors include, among others, the following: difficulties, delays, or failures we may experience in the conduct of our clinical trial; difficulties we may experience in completing the development and commercialization of voclosporin; the market for the LN, DES and FSGS business may not be as estimated; Aurinia may have to pay unanticipated expenses; estimated costs for clinical trials may be underestimated, resulting in Aurinia having to make additional expenditures to achieve its current goals; Aurinia not being able to extend or fully protect its patent portfolio for voclosporin; competitors may arise with similar products; Aurinia may not be able to obtain necessary regulatory approvals for commercialization of voclosporin in a timely fashion, or at all; and Aurinia may not be able to obtain sufficient supply to meet commercial demand for voclosporin in a timely fashion.

Phase 3. Study Type :. Interventional Clinical Trial. Actual Enrollment :. Actual Study Start Date :. Actual Primary Completion Date :. Actual Study Completion Date :. Experimental: Drug: Cenicriviroc mg cenicriviroc. Placebo Comparator: Drug: Placebo Placebo. Drug: Placebo 1 tablet QD. Huntington Park, California, United States, Los Angeles, California, United States, Oceanside, California, United States, San Francisco, California, United States, Colorado Springs, Colorado, United States, Washington, District of Columbia, United States, Bruce W.