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Study on the Effect of Hydroxychloroquine for Patients with IgA Nephropathy and High Albumin Levels

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 effects of the medication hydroxychloroquine on a kidney disease called IgA nephropathy. IgA nephropathy is a condition where a protein called IgA builds up in the kidneys, causing inflammation and affecting their ability to filter waste from the blood. The study will compare the effects of hydroxychloroquine with a placebo, which looks like the medication but does not contain any active ingredients.

The purpose of the study is to see if hydroxychloroquine can help slow down the decrease in kidney function over a period of three years in patients with IgA nephropathy. Participants in the study will receive either hydroxychloroquine or a placebo and will be monitored regularly to assess their kidney function and overall health. The study will also look at other health markers such as protein levels in urine, blood pressure, and any side effects experienced by the participants.

Throughout the study, participants will have regular check-ups to track their progress and any changes in their condition. The study aims to provide valuable information on whether hydroxychloroquine can be an effective treatment option for people with IgA nephropathy, potentially improving their quality of life and slowing the progression of the 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

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as age, medical history, and current treatments.

    Informed consent is required, ensuring understanding of the study's purpose and procedures.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to establish baseline health metrics, including kidney function and protein levels in urine.

    This assessment helps in monitoring changes throughout the study.

  3. Step 3

    Medication administration

    Participants receive either hydroxychloroquine or a placebo in the form of a 200 mg film-coated tablet.

    The medication is taken orally, with the dosage and frequency determined by the study protocol.

  4. Step 4

    Regular follow-up visits

    Regular follow-up visits are scheduled to monitor health status, including kidney function and blood pressure.

    These visits occur at intervals of 1, 2, and 3 years to assess the treatment's impact.

  5. Step 5

    Monitoring and data collection

    Throughout the study, data is collected on kidney function, protein levels, and any side effects experienced.

    Blood, urine, and DNA samples are collected for further analysis.

  6. Step 6

    Completion of study

    The study concludes after 3 years, with a final assessment to evaluate the overall impact of the treatment.

    Participants are informed of the study's findings and any implications for their health.

Who can join the trial?

10 criteria

  • Must have social security affiliation.
  • Must be treated with both SGLT2i and RAAS therapy before joining the study. These are types of medications used to protect the kidneys.
  • Must sign an informed consent, which means agreeing to participate after understanding the study details.
  • Must be over 18 years old.
  • Must have a confirmed diagnosis of IgA nephropathy through a kidney biopsy.
  • Must have a urine albumin/creatinine ratio greater than 300 mg/g. This is a measure of protein in the urine.
  • Must be on the highest tolerated dose of RAAS inhibitors for at least 3 months. These are medications that help protect the kidneys.
  • Must have at least one Oxford lesion on the most recent kidney biopsy. These are specific findings in the kidney tissue.
  • Must have an eGFR above 15 mL/min/1.73m². This is a measure of kidney function.
  • Women of childbearing age must use at least one highly effective contraceptive method.

Who cannot join the trial?

6 criteria

  • Patients who do not have a confirmed diagnosis of IgA nephropathy. This is a kidney disease that occurs when an antibody called IgA builds up in the kidneys.
  • Patients with albuminuria less than 300 mg/g. Albuminuria means there is a high level of a protein called albumin in the urine, which can be a sign of kidney damage.
  • Patients who are not receiving an optimized treatment with RAAS inhibitors. RAAS inhibitors are medications that help protect the kidneys by controlling blood pressure and reducing protein in the urine.
  • Patients without at least one Oxford lesion. Oxford lesions are specific changes in the kidney tissue that can be seen under a microscope.
  • Patients outside the age range of 18 to 65 years old.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

Hydroxychloroquine is a medication that is being studied for its potential to help patients with IgA nephropathy, a kidney disease. The trial aims to see if this medication can slow down the decrease in kidney function over three years. It is being tested in patients who have a specific level of protein in their urine and have already been receiving other treatments to protect their kidneys.

What is already known about the treatment

Hydroxychloroquine – This medication is administered orally in tablet form. It is currently being studied for its potential benefits in treating IgA nephropathy, a kidney condition. Hydroxychloroquine is primarily used to manage autoimmune diseases like lupus and rheumatoid arthritis. It works by modulating the immune system and reducing inflammation at the molecular level. It belongs to the pharmacological class of antimalarials and disease-modifying antirheumatic drugs (DMARDs).

Investigated diseases

IgA nephropathy – IgA nephropathy is a kidney disease that occurs when the antibody immunoglobulin A (IgA) builds up in the kidneys, leading to inflammation that can affect the kidneys' ability to filter waste from the blood. Over time, this condition can cause the kidneys to leak blood and protein into the urine. The disease often progresses slowly over many years, and in some cases, it can lead to chronic kidney disease. Symptoms may include blood in the urine, swelling in the hands and feet, and high blood pressure. The progression of IgA nephropathy can vary widely among individuals, with some experiencing only mild symptoms and others developing more severe kidney damage.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512653-25-00Protocol code20PH284Estimated enrolment334 patientsSponsorCentre Hospitalier Universitaire De Saint Etienne

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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.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).