Not recruitingRare disease

Study Comparing Aliskiren and Enalapril for Patients with C3 Glomerulopathy

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a kidney disease called C3 glomerulopathy. This condition affects the kidneys by causing inflammation and damage due to abnormal protein deposits. The study will compare two treatments: aliskiren, a medication that directly inhibits a protein called renin, and enalapril, an angiotensin-converting enzyme inhibitor (ACEi) commonly used to treat high blood pressure and heart conditions.

The purpose of the study is to evaluate how effective and safe aliskiren is in reducing kidney inflammation and improving kidney function compared to enalapril. Participants in the study will receive either aliskiren or enalapril for a period of time, and then switch to the other medication. This approach helps researchers understand the effects of each treatment on the disease.

Throughout the study, participants will have regular check-ups to monitor their kidney function and the levels of certain proteins in their blood. These proteins, like serum C3, are indicators of how well the kidneys are functioning and how the disease is progressing. The study aims to find out if aliskiren can be a better treatment option for people with C3 glomerulopathy compared to the current standard treatment with enalapril.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on age, diagnosis, and current treatment status.
Written informed consent is required from the patient or their legal guardians, depending on age.
Step 2
Initial assessment
An initial assessment is conducted to establish baseline health status.
This includes a kidney biopsy if not done within the last two years.
Step 3
Medication phase 1
The first phase involves taking enalapril or aliskiren orally.
Enalapril is administered as a 5 mg tablet, while aliskiren is given as a 300 mg film-coated tablet.
The medication is taken daily for a specified period.
Step 4
Cross-over phase
After the initial medication phase, a cross-over occurs where the patient switches to the other medication.
This phase also involves daily oral administration of the new medication for a specified period.
Step 5
Monitoring and assessments
Regular monitoring of serum C3 levels and kidney function is conducted.
Additional assessments include blood pressure and protein levels in urine.
Step 6
Extension study
An extension study may be conducted to further evaluate the effects of the medications.
This includes additional kidney biopsies to assess complement deposition.
Step 7
Completion of study
Upon completion, a final assessment is conducted to evaluate overall health and study outcomes.
The study is estimated to conclude by December 31, 2030.

Who can join the trial?

18 criteria

Children who are 6 years old or older and adults can participate.
The patient must have an initial diagnosis of **Dense Deposit Disease** or **C3 glomerulonephritis**. This diagnosis should be confirmed by a **kidney biopsy**, which is a procedure where a small piece of the kidney is taken to look at under a microscope. This biopsy must have been done no more than 2 years before starting the study medication.
The patient can either not be receiving any treatment at the start of the study or be on ongoing treatment with **aliskiren**, **ACE inhibitors (ACEi)**, **ARBs**, or **immune suppressive medications** like **mycophenolate mofetil (MMF)** or **corticosteroids**.
Written informed consent must be provided by:
- The patient's legal guardians if the patient is younger than 15 years old.
- Both the patient and their legal guardians if the patient is 15 years or older but younger than 18 years old.
- The patient themselves if they are 18 years or older.
- Female participants who can have children must:
  - Understand that the study medication may pose a risk to an unborn baby.
  - Agree to use a highly effective form of birth control during the study. This is not required if the participant is under 18, has not started having sexual activity, and agrees to abstain from sex, confirmed by a pregnancy test at each study visit. Acceptable methods of birth control include:
    
    Combined hormonal contraception (estrogen and progesterone) that stops ovulation, taken orally, intravaginally, or through the skin.
    Progestogen-only hormonal contraception that stops ovulation, taken orally, by injection, or as an implant.
    Intrauterine device (IUD).
    Intrauterine hormone-releasing system.
    Bilateral tubal occlusion (blocking of the fallopian tubes).
    Partner who has had a vasectomy.
    Sexual abstinence.
    Male or female condom, with or without spermicide.
    Cap, diaphragm, or sponge with spermicide.
    Agree to take a pregnancy test before starting the study medication. This also applies to women who practice complete and continued abstinence and adolescent girls who have started menstruating.
    Agree to take a pregnancy test every 3 months and at the end of the study treatment, unless they have had confirmed tubal sterilization. This also applies to women who practice complete and continued abstinence and adolescent girls who have started menstruating.

Who cannot join the trial?

10 criteria

Patients who are not diagnosed with C3 glomerulopathy, a specific kidney condition.
Individuals who are not within the specified age ranges for the study.
Participants who are part of a vulnerable population, meaning they might need special protection or care.
Patients who are not able to follow the study procedures or take the study medication as required.
Individuals who have other medical conditions that might interfere with the study or make participation unsafe.
Patients who are currently taking medications that could affect the study results.
Individuals who have had a recent change in their kidney treatment that could impact the study outcomes.
Participants who are pregnant or breastfeeding, as the study may not be safe for them or their baby.
Patients who have a history of allergic reactions to the study medication or similar drugs.
Individuals who are participating in another clinical trial that could interfere with this study.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Danderyds Sjukhus AB
Verified
Danderyd, Sweden
Region Oestergoetland
Responsive
Linkoping, Sweden
Region Vaesterbotten
Responsive
Umea, Sweden

Trial locations

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Investigated drugs

Aliskiren
is a medication used in this trial as a direct renin inhibitor. Its role is to block complement activation in the kidneys, which may help reduce kidney disease and improve kidney function in patients with C3 glomerulopathy. The study aims to evaluate its effectiveness and safety in reducing complement activation, as indicated by changes in serum C3 levels and complement deposition in kidney biopsies.
Enalapril
is an angiotensin-converting enzyme inhibitor (ACEi) used as a comparison treatment in this trial. It is a commonly used medication for managing kidney-related conditions. The trial compares the effects of enalapril with aliskiren to determine which treatment is more effective in managing C3 glomerulopathy by assessing changes in kidney function and complement activation.

What is already known about the treatment

Aliskiren
Aliskiren is administered orally in tablet form. It is currently being studied in clinical trials for its potential use in treating C3 glomerulopathy, a kidney condition. The medication works by directly inhibiting renin, an enzyme involved in the regulation of blood pressure, which may help reduce complement activation in the kidneys. Aliskiren is classified as a direct renin inhibitor and is being compared to enalapril, an existing treatment, to evaluate its effectiveness and safety in managing this renal disease.
Enalapril
Enalapril is taken orally, usually in tablet form. It is a well-established medication used to treat conditions like high blood pressure and heart failure, and it is currently being evaluated for its effectiveness in treating C3 glomerulopathy. Enalapril functions by inhibiting the angiotensin-converting enzyme (ACE), which helps relax blood vessels and reduce blood pressure. It is classified as an ACE inhibitor and is being compared to aliskiren in clinical trials to assess its efficacy and safety in patients with this specific kidney condition.

Investigated diseases

C3 glomerulopathy – C3 glomerulopathy is a rare kidney disease characterized by the abnormal deposition of complement protein C3 in the glomeruli, which are the filtering units of the kidney. This condition leads to inflammation and damage in the glomeruli, affecting the kidney's ability to filter waste and excess fluids from the blood. Over time, the disease can cause proteinuria, which is the presence of excess protein in the urine, and may lead to a decline in kidney function. The progression of C3 glomerulopathy can vary, with some individuals experiencing a slow progression while others may have a more rapid decline in kidney function. The disease is often associated with abnormalities in the complement system, a part of the immune system that helps clear pathogens from the body.