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

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What is this study about?

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.

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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
CHU Grenoble Alpes	La Tronche	France
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France

Other Sites

Site Name	City	Country
Hopital Tenon	Paris	France
Centre Hospitalier Universitaire De Nimes	Nimes	France
CHU Gabriel-Montpied	Clermont Ferrand	France
Hospital Edouard Herriot	Lyon	France
Centre Hospitalier De Valenciennes	Valenciennes	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Centre Hospitalier Universitaire De Rennes	Rennes	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Cqyuhg Hzjlbjluwrl Eq Ucywbkqcxkyhp Dv Lrwskpo	Limoges	France
Abozjvcctf Pujjirys Hsvtvwsp Dy Mrwmddmqg	Marseille	France
Ibawqpnp dg Cemrknviuxhh Hgxixsdepzj Uxhfnmlfjkfqi du Siknu Eihtdrq (udxefxy	Saint Priest En Jarez	France
Hgwwvpts Ubfmjefiybimzx Sxxifaxdvj &diupbc Hqeifzq dk Hrwefnyhwwz	STRASBOURG, Alsace	France
Cih dbbeawufeansbn	Epagny Metz Tessy	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.06.2024

Trial locations

Investigated drugs:

Hydroxychloroquine Sulfate

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.

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 ID:

2024-512653-25-00

Protocol code:

20PH284

NCT ID:

NCT06350630

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?