RecruitingRare disease

Study on the Effectiveness and Safety of Budesonide and Prednisone for Children with Primary IgA Nephropathy

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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 a kidney disease called IgA nephropathy in children. This condition affects the kidneys and can lead to problems with filtering waste from the blood. The study will test the effectiveness and safety of a medication called Budesonide, which is a type of glucocorticoid, in a special form that releases the drug slowly over time. The trial will compare this medication to a placebo and another medication called Prednisone, which is also a glucocorticoid, to see which is more effective in reducing protein levels in the urine, a common issue in IgA nephropathy.

The purpose of the study is to determine if Budesonide is more effective than a placebo and if it works better than Prednisone in reducing proteinuria, which is the presence of excess protein in the urine. Participants in the study will receive one of these treatments and will be monitored over a period of time to assess changes in their condition. The study will also look at the number of side effects and any changes in kidney function during the treatment period.

Throughout the study, children will be given either Budesonide, Prednisone, or a placebo and will be observed for 24 weeks. The main goal is to see how much the protein levels in their urine decrease by the end of the treatment compared to the beginning. The study will also track any side effects and changes in kidney function to ensure the safety and effectiveness of the treatments being tested.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Consent from the parent or legal guardian and the patient is required to participate in the study.
Eligibility includes age between 8 and 17 years, a diagnosis of primary IgA nephropathy confirmed by kidney biopsy, and specific protein levels in urine tests.
A negative pregnancy test is required at the time of qualification to start treatment.
Step 2
Randomization and initial assessment
Participants are randomly assigned to receive either the study medication or a placebo.
Initial assessments include measuring protein levels in urine and other baseline health checks.
Step 3
Treatment phase
Participants receive either Encorton (prednisone) or Entocort (budesonide) in the form of oral tablets or capsules.
The dosage and frequency of administration are determined by the study protocol and monitored by the study team.
The treatment phase lasts for 24 weeks, during which the effectiveness of the medication in reducing protein levels in urine is evaluated.
Step 4
Monitoring and follow-up
Regular follow-up visits are scheduled to monitor the participant's health and any side effects.
The primary goal is to assess the reduction of protein levels in urine after 24 weeks of treatment.
Secondary assessments include monitoring any side effects and changes in kidney function.
Step 5
End of treatment evaluation
At the end of the treatment phase, a final evaluation is conducted to measure the change in protein levels compared to the beginning of the study.
The study aims to determine the effectiveness of the medication in reducing proteinuria and to compare it with the placebo.

Who can join the trial?

7 criteria

Consent must be obtained from the parent or legal guardian and the patient to participate in the study.
The patient must be between the ages of 8 and 17 years.
The patient must have a diagnosis of primary IgA nephropathy, which is a kidney condition, confirmed by a kidney biopsy.
The patient should either not be receiving treatment or be receiving treatment with ACEI (Angiotensin-Converting Enzyme Inhibitors) or ARB (Angiotensin Receptor Blockers), which are medications used to treat high blood pressure and kidney problems.
Any previous treatment with steroids or immunosuppressive medications must have been completed at least 2 months before joining the study.
The patient must have proteinuria, which means having more than 200 mg of protein in the urine per day, or a protein-creatinine ratio (UPR) greater than 0.2 g/g in three tests. This indicates a higher level of protein in the urine.
If the patient is female and of childbearing age, a negative pregnancy test result is required at the time of qualification to start treatment.

Who cannot join the trial?

6 criteria

Patients who are not children with a condition called primary nephropathy IgA cannot participate. This is a kidney problem where a protein called IgA builds up in the kidneys.
Patients who are not within the specified age range for the study cannot participate. The study is for children.
Patients who are not able to take the study medications, such as Budesonide DR or ACEI, cannot participate. Budesonide DR is a medication that helps reduce inflammation, and ACEI stands for Angiotensin-Converting Enzyme Inhibitors, which help lower blood pressure and protect the kidneys.
Patients who are already taking certain medications that might interfere with the study drugs cannot participate.
Patients with other serious health conditions that might affect the study results cannot participate.
Patients who are unable to follow the study procedures or attend the required visits cannot participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Szpital Kliniczny Im. Karola Jonschera Uniwersytetu Medycznego Im. Karola Marcinkowskiego W Poznaniu
Poznan, Poland
Verified
Uniwersytecki Dzieciecy Szpital Kliniczny Im. L. Zamenhofa W Bialymstoku samodzielny publiczny zakład opieki zdrowotnej
Bialystok, Poland
Responsive
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Warsaw, Poland

Trial locations

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Investigated drugs

Budesonide
is a medication used in this trial to see if it can help reduce protein levels in the urine of children with a kidney condition called primary IgA nephropathy. It is a type of steroid that works by reducing inflammation in the body.
Prednisone
is another steroid used in the trial to compare its effectiveness with Budesonide in reducing protein levels in the urine. It is commonly used to treat inflammation and suppress the immune system in various conditions.
ACEI
stands for Angiotensin-Converting Enzyme Inhibitors, which are medications used to help lower blood pressure and reduce protein levels in the urine. They work by relaxing blood vessels and reducing the workload on the heart and kidneys.

What is already known about the treatment

Budesonide – Budesonide is administered orally in a delayed-release form, designed to target specific areas in the digestive tract. It is currently being studied in clinical trials for its effectiveness in treating children with primary IgA nephropathy, a kidney condition. The medication works by reducing inflammation through its action on glucocorticoid receptors, which helps decrease proteinuria, a condition where excess protein is found in urine. Budesonide is classified as a corticosteroid and is being compared to both placebo and Prednisone in ongoing research to determine its efficacy and safety.

Investigated diseases

IgA Nephropathy – This is a kidney disease that occurs when an antibody called immunoglobulin A (IgA) builds up in the kidneys, leading to inflammation. Over time, this inflammation can affect the kidneys' ability to filter waste from the blood. The disease often progresses slowly over many years, and symptoms may not be noticeable in the early stages. As the condition advances, it can cause blood and protein to appear in the urine, along with swelling in the hands and feet. The progression of the disease can vary widely among individuals, with some experiencing only mild symptoms and others developing more severe kidney damage.