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Study on the Effectiveness and Safety of Iptacopan for Patients with Complement 3 Glomerulopathy

Fast replyInvestigationalNo 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 disease called complement 3 glomerulopathy, which affects the kidneys. The study is testing a treatment called iptacopan, also known by its code name LNP023. Iptacopan is taken as a capsule and is being compared to a placebo to see if it can help reduce a condition called proteinuria, which is the presence of excess protein in the urine and is a sign of kidney problems.

The purpose of the study is to evaluate the effectiveness and safety of iptacopan in patients with complement 3 glomerulopathy. Participants in the study will be randomly assigned to receive either iptacopan or a placebo. The study will last for up to 12 months, during which participants will take the medication orally. Throughout the study, participants will have regular check-ups to monitor their health and the effects of the treatment.

This study involves both adult and adolescent participants. For adults, the main goal is to see if iptacopan is better than a placebo at reducing proteinuria. For adolescents, the study will look at the effect of iptacopan on proteinuria after six months. Participants will be closely monitored for any changes in their kidney function and overall health, ensuring that the treatment is safe and effective.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria, including age and medical history related to complement 3 glomerulopathy.

    Vaccinations against certain infections are required before starting the study treatment. If not previously vaccinated, these should be administered at least two weeks prior to the first treatment.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to establish baseline measurements. This includes collecting urine samples to measure protein levels and assessing kidney function through estimated glomerular filtration rate (eGFR).

  3. Step 3

    Treatment phase

    The treatment involves taking iptacopan or a placebo in the form of hard gelatin capsules. The medication is taken orally.

    The primary goal is to evaluate the effect of iptacopan on reducing protein levels in urine over a period of six months.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring is conducted to track changes in kidney function and protein levels in urine. This includes periodic urine collections and blood tests.

    Participants are also monitored for any side effects or adverse events related to the treatment.

  5. Step 5

    Completion of study

    Upon completion of the study period, a final assessment is conducted to evaluate the overall impact of the treatment on kidney function and protein levels.

    The study aims to determine the effectiveness and safety of iptacopan in treating complement 3 glomerulopathy.

Who can join the trial?

9 criteria

  • Participants must be **male or female** and aged between **18 and 60 years** for adults, or between **12 and 17 years** for adolescents.
  • Participants must have a diagnosis of **C3G** (complement 3 glomerulopathy) confirmed by a **kidney biopsy** within the last 12 months for adults, or within the last 3 years for adolescents. If a recent biopsy is not available, a new biopsy may be done for adults.
  • Participants must have been taking the highest recommended or tolerated dose of a medication called an **ACE inhibitor** or **angiotensin receptor blocker** for at least **90 days** before starting the study. Other medications for reducing protein in the urine should also be stable for at least 90 days.
  • Participants must have **reduced serum C3**, which means a lower level of a specific protein in the blood, at the time of screening.
  • Participants must have a **UPCR** (urine protein-to-creatinine ratio) of **1.0 g/g or higher** from a morning urine sample taken on two specific days before starting the study.
  • Participants must have an **estimated GFR** (a measure of kidney function) of **30 ml/min/1.73m² or higher** at screening and on a specific day before starting the study.
  • Participants must be vaccinated against **Neisseria meningitidis** and **Streptococcus pneumoniae** infections before starting the study treatment. If not previously vaccinated, the vaccine should be given at least **2 weeks** before the first study treatment. If treatment starts earlier, antibiotics should be used as a precaution.
  • If not previously vaccinated, participants should also be vaccinated against **Haemophilus influenzae** infections, if available, at least **2 weeks** before the first study treatment. If treatment starts earlier, antibiotics should be used as a precaution.
  • In Germany, adolescent participants must have reached **Tanner stage IV or V**, which refers to a stage of physical development, at the screening visit to join the study.

Who cannot join the trial?

10 criteria

  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients with a history of severe allergic reactions to the study medication or similar drugs are excluded.
  • Patients with uncontrolled high blood pressure are not eligible.
  • Patients with severe liver disease cannot take part in the study.
  • Patients with active infections that require treatment are excluded.
  • Patients who have received another investigational drug within the last 30 days cannot participate.
  • Patients with a history of drug or alcohol abuse in the past year are not eligible.
  • Patients with certain types of cancer, except for skin cancer that is not melanoma, are excluded.
  • Patients with a history of heart attack or stroke in the past 6 months cannot take part.
  • Patients with a history of certain blood disorders are not eligible.
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Investigated drugs

Iptacopan (LNP023) is a medication being studied for its potential to reduce proteinuria, which is the presence of excess protein in the urine. This condition is often associated with kidney diseases such as complement 3 glomerulopathy. The trial aims to determine if iptacopan is more effective than a placebo in reducing proteinuria in both adult and adolescent participants.

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 and safety in treating complement 3 glomerulopathy, a rare kidney disease. The main therapeutic indication for iptacopan is to reduce proteinuria, which is an excess of protein in the urine, a common symptom of kidney disorders. At the molecular level, iptacopan works by inhibiting a specific protein in the complement system, which is part of the immune system, thereby reducing inflammation and damage to the kidneys. It is classified as a complement inhibitor in pharmacology.

Investigated diseases

Complement 3 Glomerulopathy – This 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. The disease leads to inflammation and damage in the glomeruli, causing them to function improperly. Over time, this can result in proteinuria, where excess protein is found in the urine, and a decline in kidney function. 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. Symptoms may include swelling, high blood pressure, and changes in urine output. The exact cause of the abnormal complement activation is not fully understood, but it is believed to involve genetic and environmental factors.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509331-83-00Protocol codeCLNP023B12301Estimated enrolment111 patientsSponsorNovartis Pharma AG

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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