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Long-Term Safety Study of Iptacopan for Adults with IgA Nephropathy After Completing a Previous Study, Including ACE Inhibitors and ARBs Drug Combination

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 the long-term safety and tolerability of a medication called iptacopan in adults with a kidney disease known as IgA nephropathy. IgA nephropathy is a condition where a protein called IgA builds up in the kidneys, causing inflammation and potentially leading to kidney damage. The trial involves participants who have already completed a previous study involving iptacopan.

The purpose of this study is to ensure that iptacopan is safe and well-tolerated over a longer period. Participants will take iptacopan in the form of hard gelatin capsules, which are taken orally. The study will also involve other medications, such as ACE inhibitors and angiotensin II receptor blockers (ARBs), which are commonly used to manage blood pressure and protect kidney function. These medications may be used alone or in combination, depending on the participant's needs.

Throughout the study, participants will be monitored for any side effects or changes in their health. The study will last for a maximum of 96 weeks, during which time participants will have regular check-ups to assess their kidney function and overall health. The goal is to gather information on how well participants tolerate iptacopan over time and to ensure its safety for long-term use in managing IgA nephropathy.

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

    Joining the study

    Participation begins after signing an informed consent form. This confirms understanding and agreement to comply with the study requirements.

    Eligibility requires completion of a previous related study and a specific kidney function level, measured by eGFR, which should be at least 20 mL/min/1.73m².

  2. Step 2

    Initial assessment

    An initial assessment is conducted to ensure all criteria are met, including up-to-date vaccinations against certain infections.

    Participants should be on a stable dose of supportive care medication, such as ACE inhibitors or ARBs, unless there are documented reasons for not using them.

  3. Step 3

    Medication administration

    The medication iptacopan is administered in the form of hard gelatin capsules.

    The dosage is 200 mg taken twice daily (b.i.d.), which means once in the morning and once in the evening.

  4. Step 4

    Ongoing monitoring

    Regular monitoring is conducted to evaluate the safety and tolerability of the medication. This includes checking for any adverse effects and assessing vital signs.

    Laboratory tests are performed periodically to ensure the medication is not causing any harmful effects.

  5. Step 5

    Evaluation of kidney function

    Kidney function is assessed through changes in eGFR, which is a measure of how well the kidneys are filtering blood.

    Other evaluations include changes in protein levels in urine, which are indicators of kidney health.

  6. Step 6

    Completion of the study

    The study is designed to continue until 2033, with ongoing assessments to ensure long-term safety and effectiveness of the treatment.

    Participants will be informed of any significant findings related to their health during the study.

Who can join the trial?

6 criteria

  • You must sign a form to show you understand the study and agree to take part. You should be able to talk with the study doctor and follow the study rules.
  • If you were part of a previous related study, you must have completed all parts of that study.
  • Your eGFR (a test that measures how well your kidneys are working) must be at least 20 mL/min/1.73m². This is calculated using a specific formula based on your ethnic group and local guidelines.
  • The study doctor must believe that you could benefit from taking the study medication, iptacopan, at a dose of 200 mg twice a day.
  • You should be up to date with vaccinations against certain infections like Neisseria meningitidis, Streptococcus pneumoniae, and Haemophilus influenzae. This means you should have received any booster shots needed according to local rules.
  • You must be on a stable dose of medications called ACE inhibitors (ACEi) or Angiotensin Receptor Blockers (ARB), which are recommended for kidney health. If you cannot take these medications due to allergies or other reasons, the study doctor should note this in your records.

Who cannot join the trial?

9 criteria

  • Patients who have a different kidney condition other than IgA Nephropathy cannot participate. IgA Nephropathy is a disease that affects the kidneys.
  • 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 have other serious health conditions that might interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who are currently participating in another clinical trial cannot participate.
  • Patients who have had a recent organ transplant cannot participate.
  • Patients who have a history of drug or alcohol abuse cannot participate.
  • Patients who have allergies to the study medication or its ingredients cannot participate.
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Investigated drugs

Iptacopan is a medication being studied for its long-term safety and tolerability in adults with primary IgA nephropathy. This trial involves participants who have already completed a previous study with iptacopan. The goal is to ensure that the medication is safe to use over an extended period and to monitor any potential side effects or issues that may arise with its continued use.

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 to assess its long-term safety and tolerability for treating IgA nephropathy, a kidney disease. The medication works by inhibiting a specific protein in the immune system, which helps reduce inflammation and damage in the kidneys. Iptacopan is classified as an immunosuppressant, targeting the complement system to prevent further kidney damage.

Investigated diseases

IgA Nephropathy – IgA Nephropathy is a kidney disease that occurs when an antibody called immunoglobulin A (IgA) builds up in the kidneys. This buildup can cause inflammation that damages the kidney tissues. Over time, the inflammation can lead to the kidneys losing their ability to filter waste from the blood effectively. Symptoms may include blood in the urine, swelling in the hands and feet, and high blood pressure. The disease progresses at different rates in different individuals, and some may experience a slow decline in kidney function.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-508690-92-00Protocol codeCLNP023A2002BEstimated enrolment530 patientsSponsorNovartis Pharma AG

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