Comparative Study of Oral Cyclophosphamide and Mycophenolate mofetil in Childhood Nephrotic Syndrome

Recruiting

Brief Summary: Children withfrequent relapsing steroid dependence Nephrotic Syndrome are at risk ofcomplications during relapses and adverse effects of corticosteroid and otherimmunosuppressive therapies. Studies have suggested that relapses in frequentlyrelapsing (FR) steroid dependant (SD) nephrotic syndrome are reduced by use ofsteroid-sparing agents such as Oral cyclophosphamide or mycophenolate mofetil(MMF). Given their side effect and toxicityconcerns of oral cyclophosphamide, most expert groups now recommend levamisole orMMF in such patients with frequent relapses, before therapy withcyclophosphamide or calcineurin inhibitors are considered. The comparativeefficacy of these agents has not been studied in Indian children. Thissingle-center, open-label, non-randomized active controlled non inferiority trial,will be conducted on children who have received at-least 12 months of treatmentof MMF or a single course of oral cyclophosphamide of 8-12 weeks duration withat-least 12 months follow-up period (post CYP) between June 2021 and July 2022.Their efficacy and safety in reducing the frequency of relapses in patientswith FR/SD nephrotic syndrome will be compared.

Recruitment & Eligibility

Inclusion Criteria

Children with Frequent Relapsing Steroid Dependent Nephrotic Syndrome.

Exclusion Criteria

Congenital Nephrotic Syndrome 2.
Steroid Resistant Nephrotic Syndrome 3.
Patients with an estimated glomerular filtration rate (<60 ml/min per 1.73 m2 4.
Known secondary causes including systemic lupus, Henoch Schonlein purpura, IgA nephropathy or chronic infection (tuberculosis, HIV, hepatitis B or C.
Prior therapy with MMF, cyclosporine, tacrolimus, or cyclophosphamide in the past 6 months.

Primary Outcome Measures

Name	Time	Method
Proportion of children off steroids for atleast 6 months after starting treatment with MMF OR children off steroids for atleast 6 months after 8-12 weeks course of oral cyclophosphamide will be defined as Responders	At baseline, 3 months, 6 months, 9 months and 12 months

Secondary Outcome Measures

Name	Time	Method
Frequency of side effects in each group	In Numbers and Proportion till end of 12 months
Time to first relapse.
Number of relapses in 12 months of therapy	In numbers at the end of 12 months period
Proportion of Frequent relapsers (more than or equal to 3) in 12 months of MMF therapy	Percentage till end of 12 months
Proportion of Infrequent Relapsers after 12 months of therapy	Percentage at 12 months period

Locations (1): Dayanand Medical College and Hospital, Ludhiana, Punjab
🇮🇳
Ludhiana, PUNJAB, India
Dayanand Medical College and Hospital, Ludhiana, Punjab
🇮🇳Ludhiana, PUNJAB, India
Dr Gurdeep Singh Dhooria
Principal investigator
09915515234
gurdeep2005123@gmail.com