Clinical trial • Immunology|Nephrology

Levamisole hydrochloride for Steroid-sensitive idiopathic nephrotic syndrome|Nephrotic syndrome

Clinical trial of Levamisole hydrochloride for Steroid-sensitive idiopathic nephrotic syndrome|Nephrotic syndrome.

Overview

Trial Therapeutic Area
Immunology|Nephrology
Trial Disease
Steroid-sensitive idiopathic nephrotic syndrome|Nephrotic syndrome
Drug Modality
Small molecule
Paediatric Trial
Yes
Orphan Drug
Yes

Key dates

Initial CTIS Submission Date
15-10-2024
First CTIS Authorization Date
29-11-2024

Trial design

Randomised, placebo ("the placebo has the same composition as the tested imp with the exception of the active substance") given in addition to standard prednisolone treatment; levamisole (elmisol tablet formulations) is compared with placebo from 4 weeks to 6 months after start of the first episode. levamisole dosing information in dossier: dose unit mg/kg with max daily dose amount 2.5 (see product entries).-controlled trial in Netherlands.

Randomised
Yes
Comparator
Placebo ("the placebo has the same composition as the tested IMP with the exception of the active substance") given in addition to standard prednisolone treatment; levamisole (ELMISOL tablet formulations) is compared with placebo from 4 weeks to 6 months after start of the first episode. Levamisole dosing information in dossier: dose unit mg/kg with max daily dose amount 2.5 (see product entries).
Target Sample Size
87
Trial Duration For Participant
365

Eligibility

Recruits 87 paediatric patients.

Pregnancy Exclusion
Negative pregnancy test in girls that are of childbearing potential
Vulnerable Population
Children aged 2–16 years are included; the trial has vulnerable population provisions. Written informed consent is required (parents/guardians). Age-appropriate assent and subject information/ICF documents are provided (examples in the dossier: "Assent 2-11 years", "Child_12-15yrs", and parent ICFs, plus immunomics-specific parent and child forms).

Inclusion criteria

  • {"criterion_text":"- Steroid-sensitive INS (Remission after 4 weeks of corticosteroid treatment)"}
  • {"criterion_text":"- Weight >9 kg"}
  • {"criterion_text":"- Ability to swallow a (placebo) tablet of 5 mg (successful swallowing test in children <6 years)"}
  • {"criterion_text":"- Negative pregnancy test in girls that are of childbearing potential"}
  • {"criterion_text":"- Absence of contraindication for levamisole use: neutropenia <1500/mmP3"}
  • {"criterion_text":"- Written informed consent"}
  • {"criterion_text":"- Ability to comply with study protocol"}

Exclusion criteria

  • {"criterion_text":"- Steroid-resistant INS (persistent proteinuria at 4 weeks after start steroid treatment)."}
  • {"criterion_text":"- Previous or current malignancy, diabetes mellitus, current liver disease, or convulsions."}
  • {"criterion_text":"- Hypersensitivity to levamisole or one of its substances (lactose)"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- The occurrence of relapses within 12 months after first presentation. A relapse is defined as the recurrence of proteinuria (3+ urine dipstick or proteinuria> 200 mg/mmol creatinine) for 3 consecutive days","definition_or_measurement_approach":"A relapse is defined as the recurrence of proteinuria (3+ urine dipstick or proteinuria> 200 mg/mmol creatinine) for 3 consecutive days; occurrence of relapses within 12 months after first presentation is the primary outcome."}

Secondary endpoints

  • {"endpoint_text":"- Time to first relapse","definition_or_measurement_approach":"Measured as time from randomisation to first documented relapse."}
  • {"endpoint_text":"- Relapse rate (number of relapses per person year) over 2-year period","definition_or_measurement_approach":"Number of relapses per person-year over a 2-year period."}
  • {"endpoint_text":"- Cumulative steroid dosage up to 2 years","definition_or_measurement_approach":"Total steroid dose received by participant over up to 2 years."}
  • {"endpoint_text":"- Occurrence of adverse events and treatment discontinuation","definition_or_measurement_approach":"Recording and reporting of adverse events and any treatment discontinuations."}
  • {"endpoint_text":"- Proportion of frequent relapsers or steroid dependency over 2-year period","definition_or_measurement_approach":"Proportion of participants meeting criteria for frequent relapses or steroid dependence over 2 years."}
  • {"endpoint_text":"- Toxicity of levamisole: Proportion of patients with elevated ASAT- /ALAT-levels (>3 times upper limit of normal), neutropenia (<1500/mm3) or positive ANCA.","definition_or_measurement_approach":"Laboratory-based toxicity measures: ASAT/ALAT (>3x ULN), neutrophil count <1500/mm3, and ANCA positivity."}
  • {"endpoint_text":"- Toxicity of corticosteroids: Differences in BMI, blood pressure, height, weight, serum glucose between groups; Proportion of patients with overweight (BMI >25 kg/m2, hypertension (p>90), and hyperglycemia","definition_or_measurement_approach":"Clinical measures (BMI, BP, height, weight, serum glucose) and proportions meeting predefined thresholds (e.g. BMI>25 kg/m2)."}
  • {"endpoint_text":"- Days of school missing, outpatient visits and hospitalization days (macro-economic analysis)","definition_or_measurement_approach":"Health-economic measures: days missed from school, number of outpatient visits, hospitalization days."}
  • {"endpoint_text":"- Number of treatment interruptions","definition_or_measurement_approach":"Count of treatment interruptions per participant."}

Recruitment

Registry Or Advocacy Recruitment
True, OMON (NL-OMON27331) and Nederlandse Nierstichting (listed as source of monetary support)
Planned Sample Size
87
Recruitment Window Months
107
Consent Approach
Written informed consent is required. For minors, parental/guardian written consent is required. Age-appropriate assent and information/ICF documents are provided (examples: "Assent 2-11 years", "Child_12-15yrs", parent ICFs, and immunomics-specific parent and child forms). Language availability not specified in the record.

Geography

Total Number Of Sites
13
Total Number Of Participants
87

Netherlands

Earliest CTIS Part Ii Submission Date
25-11-2024
Latest Decision Or Authorization Date
29-11-2024
Processing Time Days
4
Number Of Sites
13
Number Of Participants
87

Sites

Site Name
Universitair Medisch Centrum Groningen
Department Name
Kindergeneeskunde
Contact Person Name
Valentina Gracchi
Contact Person Email
v.gracchi@umcg.nl
Site Name
Spaarne Gasthuis Stichting
Department Name
Kindergeneeskunde
Contact Person Name
Marlies van Houten
Contact Person Email
mavanhouten@spaarnegasthuis.nl
Site Name
Academisch Ziekenhuis Maastricht
Department Name
Kindergeneeskunde
Contact Person Name
Flore Horuz-Engels
Contact Person Email
f.engels@mumc.nl
Site Name
Amphia Hospital
Department Name
Kindergeneeskunde
Contact Person Name
Ron van Beek
Contact Person Email
rvanbeek@amphia.nl
Site Name
Deventer Ziekenhuis
Department Name
Kindergeneeskunde
Contact Person Name
Hans van der Deure
Contact Person Email
h.vanderdeure@dz.nl
Site Name
Medisch Spectrum Twente
Department Name
Kindergeneeskunde
Contact Person Name
Talia Hummel
Contact Person Email
t.hummel@mst.nl
Site Name
Leids Universitair Medisch Centrum (LUMC)
Department Name
Kindergeneeskunde
Contact Person Name
Roos Van Rooij
Site Name
Medisch Centrum Leeuwarden B.V.
Department Name
Kindergeneeskunde
Contact Person Name
Tjalling de Vries
Contact Person Email
Tjalling.de.vries@znb.nl
Site Name
Amsterdam UMC Stichting
Department Name
Kindergeneeskunde
Contact Person Name
Antonia Bouts
Contact Person Email
a.h.bouts@amsterdamumc.nl
Site Name
Haga Hospital
Department Name
Kindergeneeskunde
Contact Person Name
Gertjan Driessen
Contact Person Email
g.driessen@hagaziekenhuis.nl
Site Name
Isala Klinieken Stichting
Department Name
Kindergeneeskunde
Contact Person Name
Sara Teklenburg-Roord
Contact Person Email
s.t.a.teklenburgroord@isala.nl
Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Kindergeneeskunde
Contact Person Name
Eiske Dorresteijn
Contact Person Email
e.dorresteijn@erasmusmc.nl
Site Name
Noordwest Ziekenhuisgroep Stichting
Department Name
Kindergeneeskunde
Contact Person Name
Nynke Buter
Contact Person Email
n.h.buter@nwz.nl

Sponsor

Primary sponsor

Full Name
Amsterdam UMC Stichting
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Netherlands

Investigational products

Investigational Product Name
ELMISOL 5
Active Substance
Levamisole hydrochloride
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
Oral
Authorisation Status
No marketing authorization; orphan drug status stated
Orphan Designation
Yes
Starting Dose
2.5 mg/kg (max daily dose indicated in dossier)
Dose Levels
5 mg tablet
Maximum Dose
420
Investigational Product Name
ELMISOL 10
Active Substance
Levamisole hydrochloride
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
Oral
Authorisation Status
No marketing authorization; orphan drug status stated
Orphan Designation
Yes
Starting Dose
2.5 mg/kg (max daily dose indicated in dossier)
Dose Levels
10 mg tablet
Maximum Dose
420
Investigational Product Name
ELMISOL 25
Active Substance
Levamisole hydrochloride
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
Oral
Authorisation Status
No marketing authorization; orphan drug status stated
Orphan Designation
Yes
Starting Dose
2.5 mg/kg (max daily dose indicated in dossier)
Dose Levels
25 mg tablet
Maximum Dose
420
Investigational Product Name
ELMISOL 50
Active Substance
Levamisole hydrochloride
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
Oral
Authorisation Status
No marketing authorization; orphan drug status stated
Orphan Designation
Yes
Starting Dose
2.5 mg/kg (max daily dose indicated in dossier)
Dose Levels
50 mg tablet
Maximum Dose
420
Investigational Product Name
the placebo has the same composition as the tested IMP with the exception of the active substance
Modality
Other
Combination Treatment
Yes

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