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

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What is this study about?

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.

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

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

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

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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Frisius Heerenveen The Netherlands
University Hospital Maastricht Maastricht The Netherlands

Other Sites

Site Name City Country Status
Haga Hospital Hague The Netherlands
Deventer Ziekenhuis Deventer The Netherlands
Noordwest Ziekenhuisgroep Stichting Alkmaar The Netherlands
Isala Klinieken Stichting Zwolle The Netherlands
Amphia Hospital Breda The Netherlands
Medisch Spectrum Twente Enschede The Netherlands
Spaarne Gasthuis Hoofddorp The Netherlands
Atkcloscy Uab Amsterdam The Netherlands
Lpmjs Unotdodfcfqe Mgndknr Cbfylza (kgogv Leiden The Netherlands
Usmqzlahlwzm Mzeybdi Crgwrgk Gvikioygn Groningen The Netherlands
Embnrbp Utolxbzofuzh Mabfgux Cfjfvyl Rhxzgaefm (gmcixzm Mjg Rotterdam The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Not recruiting
25.04.2018

Trial locations

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.

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.

Trial ID:
2024-517467-23-00
Protocol code:
NL61906.018.17
Trial Phase:
Therapeutic confirmatory (Phase III)

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