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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 trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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.
Step 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.
Step 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.
Step 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.
Step 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.
Step 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 trial?

5 criteria

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 trial?

1 criterion

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

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Amsterdam UMC
Amsterdam, The Netherlands

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Investigated drugs

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.

Voclosporin

What is already known about the treatment

Voclosporin
Voclosporin is a medication given by mouth in capsule form that is used to treat lupus nephritis, a serious kidney inflammation caused by the autoimmune disease lupus. It works by blocking a protein called calcineurin in immune cells, which helps reduce the activity of the immune system that is attacking the kidneys. This drug belongs to a class of medicines called calcineurin inhibitors and is used in combination with other immunosuppressive medications to help control kidney inflammation and prevent further damage. In this clinical trial, voclosporin is being studied to see if adding it to standard treatment can more quickly reduce inflammation and improve kidney tissue healing in patients with lupus nephritis.
Mycophenolate Mofetil
Mycophenolate mofetil is an immunosuppressive medication taken by mouth in tablet or capsule form that is commonly used to treat lupus nephritis and prevent organ rejection after transplantation. It works by blocking an enzyme that immune cells need to multiply, thereby reducing the number of active immune cells that cause inflammation and damage to the kidneys. This medication belongs to a class of drugs called immunosuppressants and is often combined with corticosteroids like prednisolone as a standard treatment for lupus-related kidney disease. In this study, it serves as part of the control treatment to compare against a more intensive combination therapy that includes voclosporin.
Prednisolone
Prednisolone is a corticosteroid medication available in tablet form that is widely used to reduce inflammation and suppress the immune system in various autoimmune conditions, including lupus nephritis. It works by entering cells and affecting the production of proteins that cause inflammation, thereby decreasing swelling, redness, and immune system activity throughout the body. This medication is part of the corticosteroid drug class and is considered a standard component of treatment for lupus kidney disease, usually given in combination with other immunosuppressive drugs. In this clinical trial, prednisolone is used in both treatment groups as a baseline therapy to help control kidney inflammation.

Investigated diseases

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.