Friday, December 18, 2015

Lupus Clinical Trial Alert!


Genentech has announced the initiation of a Phase II clinical trial investigating the use of Gazyva (obinutuzumab) in patients with lupus nephritis, an inflammation of the kidney that is caused by systemic lupus erythematosus.

The aim of the study is to compare the efficacy and safety of obinutuzumab plus mycophenolate (MMF) with placebo plus MMF in Class III and IV patients with proliferative lupus nephritis. Lupus nephritis affects approximately 3 out of every 10,000 people. Up to 60% of lupus patients will develop lupus nephritis.

“Lupus nephritis is a serious disease and if not controlled, lupus nephritis can lead to kidney failure,” said Brad Rovin, MD, Head, Division of Nephrology, Ohio State University at The Ohio State University Medical Center. “It is our hope that this trial will demonstrate that obinutuzumab is an efficient and safe treatment option for patients with lupus nephritis.”

Obinutuzumab is a CD20-directed cytolytic antibody and is indicated, in combination with chlorambucil, for the treatment of patients with previously untreated chronic lymphocytic leukemia.

“The initiation of this clinical trial reinforces Genentech’s commitment to finding a treatment for patients with rare diseases, such as lupus nephritis,” said Jeffrey Siegel, MD, Senior Group Medical Director of Immunology, Genentech.

Facts about Lupus Nephritis:
·         The body’s immune system targets it own body tissues with lupus. Lupus nephritis happens when lupus involves the kidneys.
·         For many, the first noticeable symptom of lupus nephritis is the swelling of the legs, ankles and feet, however, the disease may be “silent” and not cause any symptoms. 
·         Kidney damage from lupus can be mild or severe and cause damage to the glomeruli or the filtering units of the kidney.
·         If both kidneys fail, people with lupus nephritis may need dialysis.         
·         About 90 percent of people diagnosed with lupus are women.

About the study
This study (NCT02550652) is a Phase II study comparing the efficacy and safety of obinutuzumab plus mycophenolate (MMF) with placebo plus MMF in Class III and IV patients with proliferative lupus nephritis.

The primary outcome measure is the percentage of participants who achieve complete renal response at Week 52. Participants will receive obinutuzumab 1000 milligram (mg) intravenous infusion on day 1, 15, 168, and 182 along with MMF at a starting dose of 500 mg/day administered orally in 2 or 3 divided doses. MMF dose will be up titrated based on tolerability to a maximum dose of 2.5 gram/day (g/day).

Obinutuzumab is currently approved, in combination with chlorambucil, for the treatment of patients with previously untreated chronic lymphocytic leukemia. Visit http://www.gene.com/download/pdf/gazyva_prescribing.pdf for full prescribing information.

If you have Lupus Nephritis, click this link to learn more about the study, and ask your doctor if it might be an option for you!  

*Information provided by Centron PR for Genentech

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