NCT02818738

Brief Summary

Idiopathic Nephrotic Syndrome is sensitive to steroid in 90% of children. However, most patients relapse and become steroid-dependant, with a long lasting relapsing course. The aim of this study is to assess the efficiency of a 6-months levamisole course, given early after first remission, on maintaining a relapse-free course at 12 months.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2017

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2016

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 30, 2016

Completed
1.2 years until next milestone

Study Start

First participant enrolled

September 6, 2017

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2021

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 11, 2021

Completed
Last Updated

June 8, 2022

Status Verified

May 1, 2022

Enrollment Period

3.4 years

First QC Date

June 8, 2016

Last Update Submit

June 7, 2022

Conditions

First Manifestation of Steroid Sensitive Nephrotic Syndrome

Keywords

Idiopathic nephrotic syndromeSteroid sensitive nephrotic syndromeLevamisolePrednisoneChildren

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients still in remission at 12 months after first flare of INS.

    number of patients who did not relapse compared to the number of patients who had relapsed after first flare of INS.

    12 months

Secondary Outcomes (3)

  • Compare within levamisole and placebo groups the duration of remission.

    first relapse

  • Compare within levamisole and placebo groups the frequency and level of steroid dependency

    12 months

  • Compare within levamisole and placebo groups the treatment tolerance

    12 months

Study Arms (2)

Levamisole Hydrochloride

EXPERIMENTAL

Dosage : 5, 10, 25 et 50mg. Dosage form : oral tablets, coated and non dividable for taste-masking Posology : 2.5 mg/kg on alternate days maximum 150mg. Treatment duration : 6 months

Drug: Levamisole Hydrochloride

Placebo

PLACEBO COMPARATOR

matching verum

Other: Placebo

Interventions

Levamisole HydrochlorideDRUG

Dosage : 5, 10, 25 et 50 mg. Dosage form : oral tablets, coated and non dividable for taste-masking Posology : 2.5 mg/kg on alternate days maximum 150mg. Treatment duration : 6 months

Levamisole Hydrochloride
PlaceboOTHER

matching verum

Placebo

Eligibility Criteria

Age24 Months - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age 24 months \< age \< 16 years
  • Diagnosis of first manifestation of INS defined by:
  • hypoalbuminemia \< 25g/l, proteinuria \> 0.20 g/mmol of urinary creatinine
  • normal C3 fraction of complement
  • Use of mechanical contraception for patients of reproductive age throughout the research period
  • Beneficiary of a social protection scheme (except AME)
  • Written informed consent from one of both parents
  • Ability to realise follow-up in full

You may not qualify if:

  • Anteriority of INS
  • Pregnancy, breast feeding or planned pregnancy during the study
  • Malignant pathology (antecedent or ongoing), diabetes, liver disease
  • Hypersensitivity to levamisole or its excipients (lactose)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Robert Debré

Paris, 75019, France

Location

Related Publications (1)

  • Larkins NG, Hahn D, Liu ID, Willis NS, Craig JC, Hodson EM. Non-corticosteroid immunosuppressive medications for steroid-sensitive nephrotic syndrome in children. Cochrane Database Syst Rev. 2024 Nov 8;11(11):CD002290. doi: 10.1002/14651858.CD002290.pub6.

    PMID: 39513526DERIVED

MeSH Terms

Conditions

Nephrosis, LipoidNephrotic Syndrome

Interventions

Levamisole

Condition Hierarchy (Ancestors)

NephrosisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Claire DOSSIER, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2016

First Posted

June 30, 2016

Study Start

September 6, 2017

Primary Completion

February 7, 2021

Study Completion

February 11, 2021

Last Updated

June 8, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)