Table of Contents
- Clinical trial overview
- Kidney disease studies
- Heart failure study
- What the trials measure
- Who the trials include
- Trial phases and study design
- Key points from the trial data
Clinical trial overview
The trial data show three interventional studies that include Losartan in the treatment plan or as a study treatment option.[1][2][3] These studies focus on kidney disease and heart failure, which are serious long-term conditions.[1][2][3]
All three studies are marked Authorised, and they are in later trial stages, with Phase 3 and Phase 4 designs.[1][2][3] This means the research is aimed at understanding how well the studied treatments work in larger patient groups and how they perform over time.[1][2][3]
Kidney disease studies
One study is titled Efficacy and safety of DMX-200 in patients with focal segmental glomerulosclerosis and includes adults with focal segmental glomerulosclerosis (FSGS).[1] FSGS is a kidney disease that can cause protein loss in the urine and declining kidney function.[1]
This Phase 3 study has an enrollment of 308 people and is designed to evaluate the effect of DMX-200 on urine protein and kidney function in adults with FSGS who are receiving an ARB.[1] An ARB is a type of treatment used in the study population, and Losartan is listed in the trial data as one of the drugs in this research context.[1]
The other kidney study is Atacicept in Subjects with IgA Nephropathy (ORIGIN and ORIGIN 3).[2] It includes adults with IgA Nephropathy, another kidney disease that can lead to protein in the urine.[2]
This Phase 4 study has an enrollment of 481 people and compares atacicept with placebo while also listing Losartan and enalapril in the intervention data.[2] The main kidney outcome is the urine protein to creatinine ratio (UPCR), measured at week 24 in Phase 2b and week 36 in Phase 3.[2]
Heart failure study
The third study is Pharmacological optimization in prevention in Heart Failure: A Sex-gap? and it focuses on heart failure.[3] Heart failure means the heart does not pump as well as it should.[3]
This Phase 3 trial has an enrollment of 368 people and includes a retrospective part and a prospective part.[3] The prospective part asks whether women with heart failure do better at 12 months when their guideline-directed medical therapy is up-titrated, which means the doses are adjusted upward in a planned way, compared with usual care.[3]
Losartan appears among many heart failure treatments listed in the intervention data, including several doses.[3] The study also looks at other medicines used in heart failure care, showing that the trial is about treatment patterns and possible sex differences in care.[3]
What the trials measure
The kidney trials measure changes in urine protein and kidney function.[1][2] In FSGS, the main outcomes are percent change in urine PCR from 24-hour urine collection and the slope of eGFR, which shows how kidney function changes over time.[1]
In IgA nephropathy, the main outcome is UPCR at set study visits, which helps show how much protein is in the urine.[2] These outcomes matter because protein in the urine and falling kidney function can show that a kidney disease is active or getting worse.[1][2]
The heart failure study measures all-cause mortality within 1 year, heart failure readmission, and worsening heart failure.[3] It also looks at quality of life, adherence to treatment, and side effects in the prospective part of the study.[3]
One additional safety goal appears in the FSGS study open-label extension, which checks the incidence and severity of treatment-related adverse events, including serious adverse events.[1] An open-label extension means patients continue treatment in a study phase where everyone knows what treatment is being given.[1]
Who the trials include
The trial data focus on adults with specific disease groups rather than on the general population.[1][2][3] The kidney studies include adults with FSGS or IgA nephropathy, and the heart failure study focuses on people with heart failure, with a special look at women in the prospective part.[1][2][3]
One study specifically says the FSGS patients are receiving an ARB, which shows that prior treatment is part of the study population description.[1] Another study lists Losartan together with enalapril in the intervention data, showing that treatment comparison or background treatment is part of the research design.[2]
Trial phases and study design
The FSGS study is in Phase 3, which is a later stage of clinical testing.[1] The IgA nephropathy study is in Phase 4, which usually means the treatment is being studied further after earlier development stages.[2]
The heart failure study is also in Phase 3 and has both retrospective and prospective parts.[3] A retrospective study looks back at existing data, while a prospective study follows patients forward in time from the point they enter the study.[3]
All three studies are interventional, meaning researchers are testing or comparing treatments rather than only observing patients.[1][2][3] The trial data also show different comparators, including placebo and other medicines, depending on the study.[1][2]
Key points from the trial data
Losartan appears in clinical trial data for both kidney disease and heart failure research.[1][2][3] The studies are not simple drug information pages; they are research projects that test outcomes such as protein in the urine, kidney function, death, readmission, and quality of life.[1][2][3]
The main populations are adults with FSGS, adults with IgA nephropathy, and people with heart failure, with one study paying special attention to women and possible sex gaps in treatment.[1][2][3] Together, these trials show how Losartan is being studied in broader treatment strategies for serious long-term diseases.[1][2][3]
