Efficiency of Levamisole for Maintaining Remission After the First Flare of Steroid Sensitive Nephrotic Syndrome in Children (NEPHROVIR3)
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|ClinicalTrials.gov Identifier: NCT02818738|
Recruitment Status : Recruiting
First Posted : June 30, 2016
Last Update Posted : July 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|First Manifestation of Steroid Sensitive Nephrotic Syndrome||Drug: Levamisole Hydrochloride Other: Placebo||Phase 3|
Introduction (INS) is likely a primal immune disorder. Initial treatment relies on steroid therapy. NS is sensitive to steroid in more than 90% of cases, with an excellent renal prognosis. Nevertheless, 80% of patients with steroid sensitive NS do relapse, 60% within the first year. 2/3 of them will experience steroid dependency, with a long lasting relapsing course. These patients require further immunosuppressive drugs as steroid sparing agents, such as mycophenolate, cyclophosphamide, calcineurin inhibitors or rituximab. Morbidity is high and related both to the duration of the disease, sometimes until adulthood, and to treatments side effects.
Levamisole is an immunomodulator that has been used for more than thirty years in the treatment of steroid-dependent or frequently relapsing NS. Its major advantages are its immunomodulatory action and lower and reversible toxicity.
Exact physiopathology of both INS and levamisole action remain unknown. Nevertheless, we make the hypothesis that very early treatment with levamisole may enhance its efficiency and modify the disease's course.
This is the first trial to assess the efficiency of levamisole in increasing duration of remission after the first manifestation of INS.
- A multicenter, double-blind, placebo-controlled, randomised clinical trial.
- 38 centers participate to the recruitment : 3 Pediatric Nephrology units and 35 General Pediatric units.
- 20 centers participate to the randomized phase.
Sample size :
156 patients, 78 in each group
Treatment groups :
- Levamisole Hydrochloride Dosage : 5, 10, 25 et 50mg. Dosage form : oral tablets Posology : 2.5 mg/kg on alternate days maximum 150mg. Treatment duration : 6 months
- placebo : matching verum
Study visits at inclusion, M1 (randomisation), M3, M6, M9, M12. Supplementary visit if relapse occurs.
Statistical procedure Analysis of efficiency will be performed on intention to treat population. Analysis of tolerance will be performed on randomized patients who have received at least one dose of treatment.
No intermediary analysis is planned.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||156 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Multicenter, Randomised, Double-blind Placebo-controlled Trial Assessing the Efficiency of Levamisole for Maintaining Remission After the First Flare of Steroid Sensitive Nephrotic Syndrome in Children.|
|Actual Study Start Date :||September 6, 2017|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||November 2020|
Experimental: Levamisole Hydrochloride
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
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
Placebo Comparator: Placebo
- Percentage of patients still in remission at 12 months after first flare of INS. [ Time Frame: 12 months ]number of patients who did not relapse compared to the number of patients who had relapsed after first flare of INS.
- Compare within levamisole and placebo groups the duration of remission. [ Time Frame: first relapse ]number of days between the first flare and first relapse or up to the corticodependence level in the event of relapse in the course of decreasing corticosteroid therapy.
- Compare within levamisole and placebo groups the frequency and level of steroid dependency [ Time Frame: 12 months ]Proportion of corticodependent patients and level of steroid dependency
- Compare within levamisole and placebo groups the treatment tolerance [ Time Frame: 12 months ]Frequency of adverse events apparition and frequency of discontinuation of treatment secondary at a adverse event.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02818738
|Contact: Claire DOSSIER, MD||01 40 03 24 67 ext +firstname.lastname@example.org|
|Contact: Georges DESCHENES, MD PDH||01 40 03 24 67 ext +email@example.com|
|Hôpital Robert Debré||Recruiting|
|Paris, France, 75019|
|Contact: Claire DOSSIER, MD 01 40 03 24 67 ext +33 firstname.lastname@example.org|
|Contact: Georges DESCHENES, MD PDH 01 40 03 24 67 ext +33 email@example.com|
|Principal Investigator:||Claire DOSSIER, MD||Assistance Publique - Hôpitaux de Paris|