TY - JOUR
T1 - Prevention of relapses with levamisole as adjuvant therapy in children with a first episode of idiopathic nephrotic syndrome: Study protocol for a double blind, randomised placebo-controlled trial (the LEARNS study)
AU - Veltkamp, Floor
AU - Khan, Djera H.
AU - Reefman, Christa
AU - Veissi, Susan
AU - van Oers, Hedy A.
AU - Levtchenko, Elena
AU - Mathôt, Ron A. A.
AU - Florquin, Sandrine
AU - van Wijk, Joanna A. E.
AU - Schreuder, Michiel F.
AU - Haverman, Lotte
AU - Bouts, Antonia H. M.
N1 - © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.
PY - 2019/8/1
Y1 - 2019/8/1
N2 - Introduction: Idiopathic nephrotic syndrome (INS) is characterised by a high relapse rate up to 80% after initial response to standard therapy with corticosteroids. Steroid toxicity is common and causes a great burden of disease that negatively influences the health-related quality of life (HRQoL). Recently, studies have shown that levamisole, an anthelminthic drug, significantly improves relapse-free survival in children with frequent relapses or steroid dependency. Compared with other steroid-sparing drugs, levamisole has relatively few side effects. We hypothesise that adding levamisole to standard therapy with corticosteroids in children with a first episode of INS will prevent relapses, decrease cumulative dosage of steroids used and improve HRQoL. This paper presents the study protocol for the LEARNS study (LEvamisole as Adjuvant therapy to Reduce relapses of Nephrotic Syndrome). Methods and analysis: An international, double-blind, placebo-controlled randomised trial will be conducted in 20 participating hospitals in the Netherlands and Belgium. Participants (n=92) with a first episode of INS, aged 2-16 years, who achieve remission after 4 weeks of oral prednisolone will be randomly assigned (1:1) to receive either levamisole 2.5 mg/kg alternate day or placebo added to prednisolone (18-week tapering schedule) for a total of 24 weeks. Follow-up will be until 2 years after first presentation. Additionally, parents and/or children will fill out five HRQoL questionnaires. Primary outcome of the LEARNS study is occurrence of relapses within 12 months after first presentation. Secondary outcomes include time to first relapse, cumulative steroid dose after 2 years, safety parameters and quality of life scores. Ethics and dissemination: The trial was approved by the Medical Ethical Committee. Results of the study will be published in a peer-reviewed journal.
AB - Introduction: Idiopathic nephrotic syndrome (INS) is characterised by a high relapse rate up to 80% after initial response to standard therapy with corticosteroids. Steroid toxicity is common and causes a great burden of disease that negatively influences the health-related quality of life (HRQoL). Recently, studies have shown that levamisole, an anthelminthic drug, significantly improves relapse-free survival in children with frequent relapses or steroid dependency. Compared with other steroid-sparing drugs, levamisole has relatively few side effects. We hypothesise that adding levamisole to standard therapy with corticosteroids in children with a first episode of INS will prevent relapses, decrease cumulative dosage of steroids used and improve HRQoL. This paper presents the study protocol for the LEARNS study (LEvamisole as Adjuvant therapy to Reduce relapses of Nephrotic Syndrome). Methods and analysis: An international, double-blind, placebo-controlled randomised trial will be conducted in 20 participating hospitals in the Netherlands and Belgium. Participants (n=92) with a first episode of INS, aged 2-16 years, who achieve remission after 4 weeks of oral prednisolone will be randomly assigned (1:1) to receive either levamisole 2.5 mg/kg alternate day or placebo added to prednisolone (18-week tapering schedule) for a total of 24 weeks. Follow-up will be until 2 years after first presentation. Additionally, parents and/or children will fill out five HRQoL questionnaires. Primary outcome of the LEARNS study is occurrence of relapses within 12 months after first presentation. Secondary outcomes include time to first relapse, cumulative steroid dose after 2 years, safety parameters and quality of life scores. Ethics and dissemination: The trial was approved by the Medical Ethical Committee. Results of the study will be published in a peer-reviewed journal.
KW - idiopathic nephrotic syndrome
KW - levamisole
KW - paediatric nephrology
KW - quality of life
KW - randomised controlled trial
UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85070186891&origin=inward
UR - https://www.ncbi.nlm.nih.gov/pubmed/31375606
UR - http://www.scopus.com/inward/record.url?scp=85070186891&partnerID=8YFLogxK
U2 - https://doi.org/10.1136/bmjopen-2018-027011
DO - https://doi.org/10.1136/bmjopen-2018-027011
M3 - Article
C2 - 31375606
SN - 2044-6055
VL - 9
SP - e027011
JO - BMJ Open
JF - BMJ Open
IS - 8
M1 - e027011
ER -