#1 Clinical Trials Search in Europe

Study Comparing Aliskiren and Enalapril for Patients with C3 Glomerulopathy

2 1 1 1

What is this study about?

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.

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.

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.

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.

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.

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.

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.

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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Danderyds Sjukhus AB Danderyd Sweden
Region Oestergoetland Linkoping Sweden
Region Vaesterbotten Umea Sweden
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen Gothenburg Sweden
Laenssjukhuset I Kalmar Region Kalmar Laen Kalmar Sweden
Region Uppsala Uppsala Sweden
NU Hospital Group-Vaestra Goetalandsregionen Trollhattan Sweden
Region Jaemtland Haerjedalen Ostersund Sweden
Region Skane Skanes Universitetssjukhus Lund Sweden
Karolinska University Hospital Solna Sweden
Rgeqoc Gvvnpke Visby Sweden
Uehgfrp Uiqejfpwwq Hnwagebt Uppsala Sweden

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Sweden Sweden
Not recruiting
07.10.2020

Trial locations

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.

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.

Trial ID:
2024-515892-36-00
NCT ID:
NCT04183101
Trial Phase:
Therapeutic exploratory (Phase II)

Other Trials to Consider

  • Study on Long-Term Effects of Iptacopan in Patients with C3 Glomerulopathy or Idiopathic Immune-Complex Membranoproliferative Glomerulonephritis

    Recruiting

    3 1 1
    Investigated drugs:
    Czechia France Germany Greece Italy The Netherlands +1

  • Study on the Effectiveness and Safety of Pegcetacoplan for Patients with C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis

    Not recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Germany Italy The Netherlands