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Study on the Effects of Iptacopan in Patients with Idiopathic Membranoproliferative Glomerulonephritis (IC-MPGN)

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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 Idiopathic Immune Complex Mediated Membranoproliferative Glomerulonephritis (IC-MPGN). This condition affects the kidneys and can lead to problems with kidney function. The study is testing a treatment called iptacopan, which is taken as a hard gelatin capsule. The purpose of the study is to see if iptacopan can help reduce the amount of protein in the urine, which is a sign of kidney damage, over a period of six months.

Participants in the study will be randomly assigned to receive either iptacopan or a placebo, which looks like the medication but does not contain the active ingredient. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. This helps ensure that the results are not influenced by expectations about the treatment. The study will last for up to 12 months, with regular check-ups to monitor the participants' health and the effects of the treatment.

Throughout the study, participants will have their kidney function and overall health closely monitored. This includes measuring the protein levels in their urine and checking their kidney function through blood tests. The study aims to provide valuable information about the safety and effectiveness of iptacopan in treating IC-MPGN, potentially offering a new treatment option for those affected by this kidney disease.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization

    Participants are randomly assigned to receive either iptacopan or a placebo. This process is double-blind, meaning neither the participants nor the researchers know who receives the actual medication or the placebo.

  2. Step 2

    Treatment administration

    Participants take the assigned treatment orally in the form of hard gelatin capsules. The specific dosage and frequency are determined by the study protocol and are administered consistently throughout the trial period.

  3. Step 3

    Treatment duration

    The treatment is administered for a period of 6 months. During this time, participants are monitored for changes in their condition and any side effects.

  4. Step 4

    Primary evaluation

    The main goal is to assess the reduction in protein levels in the urine after 6 months of treatment. This is measured by comparing the protein levels at the start of the trial to those at the end.

  5. Step 5

    Secondary evaluations

    Additional assessments include changes in kidney function, measured by estimated glomerular filtration rate (eGFR), and the proportion of participants achieving specific kidney health criteria.

    Participants' fatigue levels are also evaluated using a standardized questionnaire, and any significant changes in vital signs or adverse events are recorded.

  6. Step 6

    Safety monitoring

    Throughout the trial, participants undergo regular monitoring to ensure their safety. This includes checking blood pressure, heart rate, and conducting electrocardiograms (ECGs).

    For adolescent participants, additional cardiovascular assessments are performed to evaluate the effects of iptacopan on heart function.

Who can join the trial?

7 criteria

  • Participants must be **male or female** and between **12 and 60 years old** at the time of screening.
  • Participants need a confirmed diagnosis of **idiopathic IC-MPGN**, a specific kidney condition, verified by a **kidney biopsy** within the last 12 months for adults or within the last 3 years for adolescents. If no biopsy is available for adults, one must be done at screening.
  • Participants must have been taking the highest recommended or tolerated dose of **RASi** (like **ACEI** or **ARB**) for at least 90 days before the study starts. Other medications to reduce protein in urine and control the disease, such as **mycophenolic acids**, **corticosteroids**, **SGLT2 inhibitors**, and **mineralocorticoid receptor antagonists**, should be stable for at least 90 days before the study starts.
  • Participants must have a **UPCR** (a measure of protein in urine) greater than **1.0 g/g** from urine samples taken on specific days before the study.
  • Participants must have an **estimated GFR** (a measure of kidney function) greater than **30 ml/min/1.73m²** at screening and on a specific day before the study. This is calculated differently for adults and adolescents.
  • Participants must be vaccinated against **Neisseria meningitidis** and **Streptococcus pneumoniae** infections before starting the study treatment. If not previously vaccinated or if a booster is needed, the vaccine should be given at least 2 weeks before the study treatment starts. If the study treatment starts earlier, antibiotics should be given as a precaution.
  • If not previously vaccinated or if a booster is needed, participants should be vaccinated against **Haemophilus influenzae** infections, if available, at least 2 weeks before the study treatment starts. If the study treatment starts earlier, antibiotics should be given as a precaution.

Who cannot join the trial?

8 criteria

  • Patients who have a different kidney condition than Idiopathic Immune Complex Mediated Membranoproliferative Glomerulonephritis (IC-MPGN) cannot participate. This is a specific type of kidney disease.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who are not able to follow the study procedures or take the study medication as required cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate in the study.
  • Patients who have a history of severe allergic reactions to the study medication or similar medications cannot participate.
  • Patients who are currently participating in another clinical trial cannot participate in this study.
  • Patients who have certain other medical conditions that might interfere with the study cannot participate.
  • Patients who have a history of drug or alcohol abuse that might interfere with the study cannot participate.
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Investigated drugs

Iptacopan (LNP023) is a medication being studied for its potential to treat idiopathic immune complex mediated membranoproliferative glomerulonephritis (IC-MPGN). This condition affects the kidneys, leading to inflammation and damage. The trial aims to determine if iptacopan can effectively reduce proteinuria, which is the presence of excess protein in the urine, after six months of treatment.

What is already known about the treatment

Iptacopan – Iptacopan is administered orally in the form of tablets. It is currently being studied in clinical trials for its effectiveness in treating idiopathic immune complex mediated membranoproliferative glomerulonephritis (IC-MPGN). The main therapeutic indication for iptacopan is to reduce proteinuria, which is a condition characterized by excess protein in the urine, often associated with kidney disease. At the molecular level, iptacopan works by inhibiting a specific protein in the immune system, which helps to reduce inflammation and damage in the kidneys. It is classified pharmacologically as a complement inhibitor.

Investigated diseases

Idiopathic Immune Complex Mediated Membranoproliferative Glomerulonephritis (IC-MPGN) – This is a rare kidney disorder characterized by inflammation and changes in the kidney's filtering units, known as glomeruli. The disease is marked by the buildup of immune complexes, which are clusters of antibodies and antigens, leading to damage and scarring of the glomeruli. Over time, this can result in the kidneys' reduced ability to filter waste and excess fluids from the blood. Patients may experience symptoms such as blood in the urine, swelling in various parts of the body, and high blood pressure. The progression of the disease can vary, with some individuals experiencing a slow decline in kidney function, while others may have a more rapid progression.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502160-20-00Protocol codeCLNP023B12302Estimated enrolment116 patientsSponsorNovartis Pharma AG

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