Kezar Study Evaluates Potential New Treatment for People with Lupus Nephritis
Study Title:
A Phase 2b, Randomized, Controlled Double-blind, Multicenter Study Comparing the Efficacy and Safety of Zetomipzomib (KZR-616) 30 mg or 60 mg With Placebo in Patients With Active Lupus Nephritis
Sponsor Name:
Kezar Life Sciences
Purpose of Study:
The PALIZADE clinical study is evaluating zetomipzomib for the treatment of lupus nephritis, its side effects, and how it affects proteins in the urine.
What Does This Study Involve?
- The PALIZADE clinical trial is made up of 3 parts: screening, study treatment, and safety follow up:
- A screening visit is conducted by a study coordinator or clinical research nurse to determine if you are eligible to participate in the clinical trial. This includes the informed consent process, medical history and physical examination, vital signs and measurements, laboratory tests, and any necessary additional assessments such as X-rays.
- The study treatment will last for 52 weeks (1 year) with site visits occurring about every 4 weeks. At these visits, a study coordinator, clinical research nurse, or physician will conduct assessments to determine your response to therapy.
- Following 4 weeks after completion of the treatment, there will be 1 follow-up visit to report any side effects or other safety information to the investigator.
- There is a 2 in 3 chance of being placed in a patient group receiving zetomipzomib. All patients will be randomized into one of three groups to receive either a 30 mg dose of zetomipzomib, a 60 mg dose of zetomipzomib, or placebo through a weekly injection under the skin. During the clinical trial, you will be able to continue taking other medications that your physician has prescribed for treating your lupus nephritis.
Accommodations for study participation, including clinical trial assessments at no cost, remote home trial services*, and travel concierge* may be available.
*Remote home trial and travel concierge services vary by clinical trial location.
To Consider Participation in this Study, You Must:
- Be at least 18 years of age.
- Have a kidney biopsy completed within the last year showing a clinical diagnosis of active lupus nephritis (Class III or IV, with or without Class V, or Class V alone). If you have not had a biopsy in the past year, you will need to complete a biopsy during the screening period for participation in the clinical trial.
- Have a urine protein to creatinine ratio (UPCR) ≥1.0 (Class III/IV +/-V) or UPCR ≥2.0 (Class V)
- Have a body mass index (BMI) of ≥18 kg/m2.
- Have a positive ANA test result and/or a positive anti-dsDNA serum antibody test.
- Have adequate blood cell counts, liver, and kidney function based on necessary lab results.
- Be willing to take steroids and mycophenolate mofetil or equivalent.
If you have the following, you will not be able to participate:
- Current or medical history of:
- Central nervous system manifestations of SLE.
- Overlapping autoimmune condition that may affect study assessments/outcomes.
- Antiphospholipid syndrome with history of thromboembolic event within the 52 weeks prior to Screening.
- Thrombocytopenia or at high risk for developing clinically significant bleeding or organ dysfunction requiring therapies (i.e., plasma exchange or acute blood or platelet transfusions).
- Solid organ transplant or planned transplant during study.
- Cancer of any type, with exceptions for non-melanoma skin cancers and certain cancers >5 years ago.
- Received dialysis within the 52 weeks prior to Screening.
- Positive test at Screening for HIV, hepatitis B/C.
- Known intolerance to mycophenolate mofetil or equivalent and corticosteroids.
Study Type:
- Interventional
- Placebo-controlled, double-blind Phase 2b clinical trial
- Global study; The PALIZADE clinical trial is being conducted in the United States and globally in 21 countries
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. If you are a person living with lupus or a caregiver and you want to learn more about clinical trials and other research opportunities that may be right for you, sign up for the Lupus Foundation of America’s Research Accelerated by You (RAY®) patient and caregiver registry today. Compensation is available.