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Aliskiren

Clinical trials are investigating Aliskiren in people with C3 glomerulopathy, a kidney disease linked to the complement system. The main goal is to see whether it can help lower disease activity, protect kidney function, and how it compares with enalapril. These studies also look at safety and measures of complement activation.

Table of Contents

Trial overview

The clinical trial in the source data studied Aliskiren in people with C3 glomerulopathy, which is a kidney disease linked to the complement system.[1]

This was a Phase 2 interventional study, and it was completed with 30 enrolled participants.[1]

The study aimed to assess whether Aliskiren could help reduce complement activation in the kidneys and support better kidney outcomes.[1]

Study design and treatment comparison

The trial compared Aliskiren with enalapril, which was the currently used treatment in this study setting.[1]

The treatment arms listed in the source were oral Rasilez 300 mg film-coated tablets and oral Enalapril Viatris 5 mg comprimidos EFG.[1]

The brief summary says the project used a cross-over study and an extension study.[1]

In a cross-over study, the same people receive different treatments in a planned order so results can be compared more fairly within the same patient group.[1]

Who participated

The study was designed for patients with C3 glomerulopathy.[1]

The trial data do not give more detailed inclusion or exclusion rules, so the main known target group is people with this kidney disease.[1]

This makes the study relevant to a rare group of patients whose disease is linked to abnormal complement activity in the kidney.[1]

What was measured

The main outcome in the cross-over part was serum C3.[1]

Serum C3 is a blood marker related to the complement system, and changes in this marker can show whether disease activity is going up or down.[1]

In the extension study, the trial measured serum C3 again and also looked at complement deposition in renal biopsies.[1]

A renal biopsy is a small sample of kidney tissue, and complement deposition means build-up of complement proteins in that tissue.[1]

The brief summary also says the study assessed safety and looked for signs of reduced systemic and local complement activation.[1]

Why this trial matters

This trial is important because it focuses on a disease where the complement system may damage the kidneys.[1]

By comparing Aliskiren with enalapril, researchers were trying to see whether Aliskiren could offer a different way to manage this condition.[1]

The study also used tissue and blood markers, which can help show whether a treatment changes the disease process, not just symptoms.[1]

Trial ID Phase Condition studied Status Enrollment
NCT04183101 Phase 2 C3 glomerulopathy Completed 30

FAQ

  • What condition is being studied with Aliskiren? The trial is studying C3 glomerulopathy, a complement-mediated kidney disease. The research looks at whether Aliskiren can help reduce disease activity in the kidneys.
  • What is the main goal of the Aliskiren trial? The main goal is to assess the effect and safety of Aliskiren. Researchers want to see if it can reduce complement activation and help stabilize or improve kidney function.
  • Who can participate in this study? The study is for patients with C3 glomerulopathy. The trial data do not list more detailed participant rules.
  • What phase is the Aliskiren trial? This is a Phase 2 trial. Phase 2 studies usually look more closely at whether a treatment may work and how safe it is in a specific patient group.
  • What outcomes are being measured? The trial measures serum C3 during the cross-over study. In the extension study, it also looks at serum C3 and complement deposition in kidney biopsies.

Ongoing Clinical Trials on Aliskiren

  • Study Comparing Aliskiren and Enalapril for Patients with C3 Glomerulopathy

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Sweden

Glossary

  • C3 glomerulopathy: A kidney disease caused by abnormal activity of the complement system. It can damage the small filters in the kidneys.
  • Complement system: A part of the immune system that helps the body fight infection. In some diseases, it becomes overactive and can harm tissues.
  • Complement activation: The process of turning on the complement system. In this trial, researchers want to see if treatment can reduce this activity.
  • Serum C3: A blood measure of the C3 protein, which is part of the complement system. It is used here as a marker of disease activity.
  • Renal biopsy: A small sample of kidney tissue taken for testing. It helps doctors look for signs of disease inside the kidney.
  • Complement deposition: Build-up of complement proteins in tissue. In this study, researchers check whether this build-up changes in kidney biopsies.
  • Cross-over study: A study design where participants receive different treatments in a planned order. This helps compare treatments in the same people.
  • Extension study: A longer follow-up part of a trial. It lets researchers keep measuring effects after the main study period.
  • Phase 2: A trial stage that tests whether a treatment may work in a specific condition and continues to assess safety.
  • Interventional study: A study where researchers assign a treatment and then measure its effects.

References