Introduction:
Membranous nephropathy(MN)is the most common cause of nephrotic syndrome in the elderly. The most widely accepted treatment is alternate monthly steroid and cyclophosphamide, also known as the modified Ponti celli regimen(MPR). It requires hospitalization for three days every alternate month for six months. Considering the widely different educational and economical background of patients at our centre, compliance to MPR may not be universal. We want to compare a complete oral regimen of steroid and cyclophosphamide for 6 months with MPR. It aims to increase patient compliance, avoid hospitalization and reduce the cumulative steroid dose.
Methods:
We randomly assigned patients more than 18 years of age with membranous nephropathy diagnosed on renal biopsy, and classified as moderate risk, high risk or very risk (as defined by KDIGO 2021 Glomerular disease guidelines), and with estimated GFR more than 30 ml/min/1.73m2 of body surface area (CKD-EPI formula), to receive either daily oral prednisone (0.5 mg/kg/day) for 3 months followed by tapering over next 3 months by 5 mg every two weeks(total duration of steroids 6 months), and daily oral cyclophosphamide (2mg/kg/day) for first 3 months [intervention group] or the MPR (Month 1,3,5- Injection methylprednisolone 1000 mg intravenously once daily for 3 days, followed by 0.5 mg/kg/day prednisone for next 27 days and month 2,4,6- ral cyclophosphamide 2mg/kg/day for 30 days). Primary objective was to compare the remission rate (complete or partial) at 6 months in patients treated with daily oral steroid and cyclophosphamide versus MPR group. Secondary objective was to compare adverse events in both groups.
Results:
We report the results of 40 patients, 21 in the intervention group and 20 in the MPR group. The mean age, mean 24 hours urine protein and mean estimated GFR were 46±15.3 years, 9.09±3.9 g and 80±26 ml/min/1.73m2 in the intervention group and 50.3±8.63 years, 8.6±3 g and 75±30 ml/min/1.73m2 in MPR group respectively. Serum PLA2R was positive in 8 patients (42.1%) and data not available for two patients in the intervention group, and in 9 patients (47.3%) in MPR group, data not available for one patient in this group. At 6 months, 18 out of 21 (85.7%) patients in the complete oral group and 16 out of 20 (80 %) patients in the MPR group had attained a composite of complete or partial remission. Majority were due to partial remission in each group. One patient in MPR group was switched to other immunosuppression at 6 months in view of worsening proteinuria. Adverse events occurred in 11 patients (52%) in oral group and in 12 patients (60%)in MPR group. Serious adverse events occurred in 2 patients in each group. Infection was the most common adverse event noted in both groups. Only one patient had transient worsening of blood glucose in the experimental arm whereas new onset diabetes occurred in two patients in the MPR group
Conclusions:
Daily oral steroid and cyclophosphamide regimen had similar response rates when compared to the cyclical steroid plus cyclophosphamide group (MPR) group. The risk of adverse events was also comparable between the two groups. A larger sample size is needed to check for statistical significance.
I have no potential conflict of interest to disclose.
I did not use generative AI and AI-assisted technologies in the writing process.