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Zetomipzomib for Lupus Nephritis
Phase 2
Recruiting
Led By Steven Kimmel, MD
Research Sponsored by Kezar Life Sciences, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Unequivocally positive ANA test result and/or a positive anti-dsDNA serum antibody test
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through week 13, week 25, week 37, and week 53
Awards & highlights
Study Summary
This trial looks at whether a drug can help people with LN achieve better kidney health over 52 weeks.
Who is the study for?
This trial is for adults with active lupus nephritis, a kidney condition caused by systemic lupus erythematosus. Participants must have a BMI of ≥18, proper organ function, and confirmed diagnosis through biopsy within the last year. They should not have central nervous system SLE effects, transplants planned or done recently, certain infections like HIV or hepatitis B/C, intolerance to specific medications used in treatment (MMF/corticosteroids), other autoimmune conditions that could interfere with results, recent serious blood disorders or malignancies except some skin cancers.Check my eligibility
What is being tested?
The study tests the effectiveness and safety of zetomipzomib at two doses (30 mg and 60 mg) versus a placebo over one year in achieving renal response in patients with active lupus nephritis. It aims to see if this drug can help manage kidney inflammation associated with lupus more effectively than no treatment.See study design
What are the potential side effects?
While the side effects of zetomipzomib are not detailed here, similar drugs often cause immune system reactions, potential liver issues due to medication processing demands on the body's detoxification systems; gastrointestinal disturbances as common responses to foreign substances; fatigue from bodily resources being directed towards healing processes; and possible impact on blood cell counts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a positive ANA or anti-dsDNA test result.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline through week 13, week 25, week 37, and week 53
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through week 13, week 25, week 37, and week 53
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To evaluate safety of zetomipzomib
To evaluate the efficacy of zetomipzomib
Secondary outcome measures
CRR
Partial Renal Remission (PRR)
Other outcome measures
CRR and no prednisone use
CRR and successful prednisone taper
CRR with UPCR ≤ ULN
+5 moreTrial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: zetomipzomib 60 mg + standard-of-careExperimental Treatment1 Intervention
Initial 30 mg dose of zetomipzomib, followed by weekly doses of 60 mg zetomipzomib through 52 weeks of the treatment period.
Group II: zetomipzomib 30 mg + standard-of-careExperimental Treatment1 Intervention
Initial 30 mg dose of zetomipzomib, followed by weekly doses of 30 mg zetomipzomib through 52 weeks of the treatment period.
Group III: placebo + standard-of-carePlacebo Group1 Intervention
Initial 30 mg dose of placebo, followed by weekly doses (30 mg or 60 mg) of placebo through 52 weeks of the treatment period.
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Who is running the clinical trial?
Kezar Life Sciences, Inc.Lead Sponsor
6 Previous Clinical Trials
361 Total Patients Enrolled
1 Trials studying Lupus Nephritis
69 Patients Enrolled for Lupus Nephritis
Steven Kimmel, MDPrincipal InvestigatorWest Broward Rheumatology Associates, Inc.
David Tietjen, MDPrincipal InvestigatorNephrology Consultants, LLC
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have antiphospholipid syndrome and had a clotting event in the last year.You have tested positive for HIV, hepatitis B, or hepatitis C during the screening.I have a positive ANA or anti-dsDNA test result.I have been on dialysis in the last year.I am allergic or cannot tolerate MMF or steroids.Your kidney function is good, with an eGFR of at least 30 mL/min/1.73 m^2.I have cancer, but it's not skin cancer or a cancer I was cured of over 5 years ago.My kidney disease was confirmed by a biopsy within the last year.My blood, liver, and kidney functions are all within normal ranges.I am at high risk for serious bleeding or organ issues needing immediate treatment.You need to have a body mass index of at least 18 kilograms per square meter.I have or had brain or nerve symptoms due to lupus.I have had or am planning to have a solid organ transplant.I have an autoimmune condition that could interfere with the study.Your urine protein-to-creatinine ratio is very high.
Research Study Groups:
This trial has the following groups:- Group 1: zetomipzomib 30 mg + standard-of-care
- Group 2: zetomipzomib 60 mg + standard-of-care
- Group 3: placebo + standard-of-care
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many volunteers have registered for this clinical examination?
"Affirmative. Clinicaltrials.gov indicates that recruitment is still occurring for this clinical trial, which was initially uploaded on May 26th 2023 and updated June 5th 2023. 279 individuals are required to take part in the study at 4 distinct medical sites."
Answered by AI
Are numerous medical facilities administering this clinical investigation within the state?
"This trial is currently administered from 4 different sites, located in Miami, Tamarac and Dallas among others. It may be beneficial to pick the location closest to you if you wish to limit your commuting requirements as a participant."
Answered by AI
Is this study actively seeking out participants at the moment?
"As evidenced by clinicaltrials.gov, this trial is actively recruiting for participants. This experiment was initially published on May 26th 2023 and has undergone a recent edit as of June 5th 2023."
Answered by AI
Is zetomipzomib 30 mg + standard-of-care a dependable medication regimen for patients?
"Given the Phase 2 status of this treatment, a score of two was assigned to zetomipzomib 30 mg + standard-of-care in terms of safety as there is some available data confirming its security but none on efficacy."
Answered by AI
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