A Study of Prednisolone, Mycophenolate Mofetil and Voclosporin Compared to Prednisolone and Mycophenolate Mofetil in Patients with Lupus Nephritis

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What is this study about?

This study involves patients with Lupus Nephritis, which is a serious kidney complication that can occur in people who have systemic lupus erythematosus, a condition where the immune system mistakenly attacks the body’s own tissues. The study will test a treatment combination that includes voclosporin, mycophenolate mofetil, and prednisolone, and compare it to a treatment that uses only mycophenolate mofetil and prednisolone. Mycophenolate mofetil and prednisolone are medications that help reduce the activity of the immune system to prevent it from damaging the kidneys. Voclosporin is an additional medication that also works to calm down the immune system. The purpose of this study is to find out whether adding voclosporin to the standard treatment can more quickly reduce inflammation in the kidneys and whether this leads to better outcomes for patients.

Patients participating in this study will be randomly assigned to receive either the three-medication combination or the two-medication combination. During the study, patients will undergo kidney biopsies, which are procedures where a small sample of kidney tissue is taken using a needle, to examine the level of inflammation and the presence of certain immune cells called macrophages in the kidney. These biopsies will be performed at the beginning of the study and again after three months of treatment. The study will also collect blood and urine samples to look for markers that might help doctors understand how well the treatment is working without needing to perform repeat kidney biopsies in the future. The study will follow patients for up to two years to see if early improvements in kidney inflammation are connected to long-term kidney health.

The study will also include two comparison groups: one group of patients with systemic lupus erythematosus who do not have kidney involvement, and one group of healthy individuals without any disease. These groups will help researchers better understand the differences in immune cell patterns between people with lupus nephritis, those with lupus without kidney problems, and healthy individuals. The information gathered from all participants will be used to identify potential new ways to monitor disease activity and treatment response that could make future care easier and less invasive for patients with lupus nephritis.

1 Initial kidney biopsy

At the start of the study, a kidney biopsy will be performed. This is a procedure where a small sample of kidney tissue is taken using a needle to examine it under a microscope.

The biopsy will help determine the type and severity of kidney inflammation caused by lupus nephritis.

2 Random assignment to treatment group

After the initial biopsy, you will be randomly assigned to one of two treatment groups. This means it will be decided by chance, like flipping a coin, which treatment you will receive.

Treatment group 1: You will receive three medications: voclosporin, mycophenolate mofetil, and prednisolone.

Treatment group 2: You will receive two medications: mycophenolate mofetil and prednisolone.

3 Treatment period

You will take the assigned medications for 3 months.

If you are in treatment group 1, you will take voclosporin 7.9 mg soft capsules by mouth, along with mycophenolate mofetil and prednisolone.

If you are in treatment group 2, you will take mycophenolate mofetil and prednisolone by mouth.

The exact dosage and frequency of each medication will be determined by the study doctor based on your individual situation.

4 Blood and urine sample collection during treatment

During the 3-month treatment period, blood and urine samples will be collected at scheduled visits.

These samples will be tested to monitor how your body is responding to the treatment and to check for specific markers related to kidney inflammation.

5 Second kidney biopsy after 3 months

After completing 3 months of treatment, a second kidney biopsy will be performed.

This biopsy will allow comparison of the kidney tissue before and after treatment to assess how well the treatment has reduced inflammation and other changes in the kidney.

6 Continued monitoring

Following the second biopsy, you will continue to be monitored for up to 2 years from the start of the study.

During this time, regular visits will be scheduled to check your kidney function, measure protein levels in your urine, and collect blood and urine samples.

This long-term monitoring will help assess whether the treatment leads to lasting improvement in your condition.

Who Can Join the Study?

You must have lupus nephritis, which is kidney inflammation caused by lupus, a condition where the body’s immune system attacks its own tissues. This should be either newly diagnosed or a flare-up of existing disease according to specific medical guidelines, and there should be a medical reason to perform a kidney biopsy, which is a procedure to take a small sample of kidney tissue for examination. The kidney damage should be class III or IV type.
You must be between 16 and 70 years old.
Your kidney function must be at a certain level. Specifically, your eGFR, which is a measurement of how well your kidneys are filtering waste from your blood, must be greater than 20 milliliters per minute. This will be measured using a substance called cystatin C in your blood.
Alternatively, if you have lupus but without kidney involvement, you may participate as a comparison group. You must have a diagnosis of SLE, which stands for systemic lupus erythematosus, the full medical name for lupus, according to specific medical guidelines, and be between 16 and 70 years old.
Healthy volunteers between 16 and 70 years old with no medical problems may also participate as a control group for comparison purposes.

Who Cannot Join the Study?

The exclusion criteria information is not available in the provided study documentation

Where you can join this trial?

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Site Name	City	Country	Status
Ayfapwfww Ujc	Amsterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	01.01.2026

Trial locations

Investigated drugs:

Voclosporin

Prednisolone is a steroid medication that helps reduce inflammation and calm down an overactive immune system. In this trial, it is used to help control the inflammation caused by lupus nephritis, which is kidney inflammation related to lupus.

Mycophenolate mofetil is a medicine that suppresses the immune system to prevent it from attacking the body’s own tissues. It is commonly used to treat lupus nephritis by reducing the immune system’s harmful activity against the kidneys.

Voclosporin is an immunosuppressive medication that works by blocking certain immune system cells called T-cells. In this study, it is being tested as an additional treatment on top of the standard medications to see if it can help achieve better control of kidney inflammation more quickly.

Investigated diseases:

Lupus nephritis

Lupus Nephritis – Lupus nephritis is a kidney inflammation that occurs as a complication of systemic lupus erythematosus, an autoimmune disease. In this condition, the body’s immune system mistakenly attacks the kidneys, causing damage to the filtering units called glomeruli. The disease progresses when immune complexes deposit in the kidney tissue, leading to inflammation and scarring. Patients may experience swelling in the legs and ankles, changes in urination patterns, and protein appearing in the urine. The condition can affect different parts of the kidney with varying severity, classified into different classes based on the extent and type of damage. Without proper management, the inflammation can lead to progressive loss of kidney function over time.

Trial ID:

2025-522187-32-01

Trial Phase:

Therapeutic confirmatory (Phase III)

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A Study of Prednisolone, Mycophenolate Mofetil and Voclosporin Compared to Prednisolone and Mycophenolate Mofetil in Patients with Lupus Nephritis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?