Kezar Kzr-616 For The Treatment Of Proteinuria In Patients With Lupus Nephritis
Posted Date: Sep 9, 2019
- Investigator: Prakash Gudsoorkar
- Specialties:
- Type of Study: Drug
This is a Phase 2 trial comparing safety and efficacy of a study drug to placebo in patients with SLE nephritis. Eligibility will be determined with blood and urine samples, and chest x-ray. After qualification, subjects will receive Subcutaneous injections of study drug or placebo every week for 13 weeks. Follow-up will be done for two months, so the entire duration of the study is about 6 months. Evaluation of blood and urine samples, 24 hour urine samples as well as physical exams and assessments of SLE disease activity (symptoms, etc) will be done regularly. Subjects will receive compensation for time and travel to each study visit. The most common side effects from the study drug are: Bruising, discoloration (changing to a different color), discomfort, erythema (abnormal redness of the skin resulting from dilation of blood vessels, as in sunburn or inflammation) Induration (hardening or thickening of tissue), pain and tenderness, pruritus (itching) and swelling (inflammation). Reactions to the injection can include symptoms of hypotension.
Criteria:
Adults With A Recent Kidney Biopsy Showing Lupus Nephritis, Recent Induction Therapy With Mmf Or Mpa, Upcr (Urinary Protein To Creatinine Ratio) Greater Than 1 Gram In 24 Hours, Egfr Greater Than 40. Women Must Not Be Pregnant, And Both Men And Women Must Agree To Birth Control If Applicable. Subjects Must Be Generally Healthy Other Than Lupus, And Blood Pressure Must Be Under Control.,
Keywords:
Nephritis, Kidney, Sle
For More Information:
Heather Duncan, Phd
513-559-3362
heather.duncan@uc.edu