Not recruiting

Study of levamisole and prednisolone combination to prevent nephrotic syndrome relapse in children aged 2-16 years with first episode of steroid-sensitive disease

Fast replyInvestigationalNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

This study focuses on children with steroid-sensitive idiopathic nephrotic syndrome, a kidney condition that causes protein to leak into urine. The research examines whether adding levamisole to standard treatment can prevent the disease from coming back. The medication being tested is called Elmisol, which comes in different strength tablets (5 mg, 10 mg, 25 mg, and 50 mg).

The purpose of this research is to determine if using levamisole together with corticosteroids (standard treatment) for 6 months can reduce the chances of the disease returning within 12 months. Some patients will receive levamisole tablets while others will receive placebo tablets. The treatment period lasts for 24 months, during which doctors will monitor how often the disease returns and check for any side effects.

During the study, doctors will track how quickly and how often the disease returns, measure the total amount of medications needed, and monitor various health indicators. They will also keep records of any missed school days and hospital visits. The medication is taken by mouth, and the dose is calculated based on the patient's weight.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment phase
You will receive prednisolone (corticosteroid) treatment for 4 weeks to achieve initial remission
During this period, your healthcare provider will monitor your response to the treatment
Step 2
Study medication assignment
After successful initial treatment, you will receive either levamisole tablets or placebo tablets
The tablets will be taken by mouth daily
You will continue taking these tablets from week 4 to month 6 of your treatment
Step 3
Monitoring period - first year
Your condition will be monitored for 12 months to check for any return of symptoms
Regular urine tests will be performed to check for protein levels
Blood tests will monitor your liver function and white blood cell count
Your height, weight, and blood pressure will be regularly measured
Any missed school days, clinic visits, or hospital stays will be recorded
Step 4
Extended follow-up period
Monitoring will continue for an additional year (total of 2 years)
The number of symptom returns and total steroid medication needed will be tracked
Regular health checks will continue to monitor for any side effects
Your growth and development will be monitored through regular measurements

Who can join the trial?

9 criteria

Patient must have responded positively to steroid treatment (showing improvement after 4 weeks of corticosteroid medication)
Patient must weigh more than 9 kilograms
Patient must be able to swallow a 5 mg tablet (for children under 6 years, this will be tested)
For girls who have reached puberty, a pregnancy test must be negative
Patient must not have neutropenia (a condition where the number of white blood cells called neutrophils is lower than 1500 per cubic millimeter of blood)
Parents or legal guardians must provide written consent for participation in the study
Patient and family must be able to follow all study requirements and scheduled visits
Patient must be between 2 and 16 years old
Both male and female patients can participate

Who cannot join the trial?

12 criteria

Children younger than 2 years or older than 16 years of age
Patients who are allergic to levamisole or any components of the study medication
Patients with steroid-resistant nephrotic syndrome (when the condition does not improve with steroid treatment)
Patients who have previously received treatment with levamisole
Children with severe kidney impairment
Patients with active infections
Children with compromised immune system
Patients with liver disease
Children who are participating in other clinical trials
Patients who cannot follow the study protocol or attend regular follow-up visits
Children with known genetic causes of nephrotic syndrome
Patients who have received other immunosuppressive medications in the past 3 months

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

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

Verified
Amphia Hospital
Breda, The Netherlands
Responsive
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Rotterdam, The Netherlands
Responsive
Leids Universitair Medisch Centrum (LUMC)
Leiden, The Netherlands

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Levamisole
is a medication used to prevent relapses in children with nephrotic syndrome (a kidney condition that causes the body to release too much protein in the urine). It works as an immune system modulator and is given as an additional treatment alongside corticosteroids. This medication helps reduce the frequency of disease relapses in children who have experienced their first episode of nephrotic syndrome.
Corticosteroids
are medications that help reduce inflammation and suppress the immune system. In nephrotic syndrome, they are used as the main treatment to decrease protein loss through the kidneys and manage the symptoms of the condition. These medications help achieve initial remission of the disease.

Levamisole Hydrochloride

What is already known about the treatment

Levamisole - An oral medication originally developed as an anti-parasitic drug that has found additional use in treating steroid-sensitive nephrotic syndrome in children. This immunomodulating agent works by enhancing T-cell function and cellular immunity, helping to prevent relapses in kidney conditions when used alongside corticosteroids. Levamisole is typically administered in tablet form and is classified as an immunostimulant drug that helps maintain remission in nephrotic syndrome, particularly in pediatric patients aged 2-16 years. The medication is often prescribed as an adjuvant therapy, meaning it's used in combination with standard steroid treatment to improve overall treatment outcomes and reduce the frequency of disease relapses.

Investigated diseases

Steroid-sensitive Idiopathic Nephrotic Syndrome - A kidney condition that causes the body to excrete too much protein in the urine. It typically begins suddenly and is characterized by swelling (edema), particularly around the eyes and in the legs and feet. The condition responds well to steroid treatment initially, though it may come and go over time. The syndrome most commonly affects young children, causing changes in the kidney's filtering system that allow protein to leak into urine. The exact cause remains unknown (idiopathic), but the immune system is believed to play a significant role.