Table of Contents
- Trial overview
- Who was studied
- What the study measured
- Trial phase and size
- Trial status and design
- Important patient terms
Trial overview
The source data describes one clinical trial of Zetomipzomib, also listed as KZR-616, in patients with active lupus nephritis.[1] The study was called PALIZADE and was designed to look at both efficacy and safety.[1]
Who was studied
This trial focused on people with active lupus nephritis, which is kidney inflammation linked to an autoimmune disease.[1] The study included patients with active Class III or IV lupus nephritis, with or without Class V, and also patients with pure Class V lupus nephritis.[1]
These class names describe the pattern of kidney disease seen in lupus nephritis.[1] In simple terms, the study looked at people with specific forms of lupus-related kidney damage, including both mixed and single-class disease.[1]
What the study measured
The main outcome, or primary efficacy endpoint, was the proportion of patients who achieved CRR at Week 37.[1] CRR means complete renal response, which is a study term for a strong kidney improvement.[1]
This endpoint tells researchers how many patients reached the target kidney response by the planned time point.[1] The trial summary also states that the study was designed to evaluate both efficacy and safety.[1]
Trial phase and size
The trial was a Phase 2 study.[1] Phase 2 studies usually explore whether a treatment shows early benefit while continuing to collect safety information.
The planned enrollment was 247 patients.[1] This number shows the study was large enough to assess the treatment in a meaningful group of patients with lupus nephritis.[1]
Trial status and design
The trial status was Completed.[1] It was an interventional study, which means researchers gave a treatment and then measured the results.[1]
The source data lists Zetomipzomib as a drug given by subcutaneous injection in the study.[1] The trial also included other treatments in the study record, but the source summary mainly highlights Zetomipzomib as the investigational treatment for active lupus nephritis.[1]
Important patient terms
- Lupus nephritis means lupus is affecting the kidneys and causing inflammation.[1]
- Class III, IV, or V are labels for different kidney patterns seen in lupus nephritis.[1]
- Efficacy means how well a treatment works in the trial.[1]
- Safety means how well people tolerate the treatment in the study.[1]
- Week 37 is the time point when the main result was checked.[1]
