A Single-Center, open label, Randomized, Controlled Study of Hydroxychloroquine Sulfate in the Treatment of Low Risk PLA 2 R-Associated Membranous Nephropathy

Abstract Objective: To evaluate the efficacy and safety of hydroxychloroquine sulfate (HCQ) in the treatment of low risk phospholipase A₂ receptor (PLA₂R)-associated membranous nephropathy (MN). Methods: A total of 110 patients with low risk PLA₂R-associated MN were included in the study. Patients who met the inclusion and exclusion criteria were assigned randomly to two groups: the HCQ treatment group and the control group. The control group was given adequate support treatment according to the guidelines, while the HCQ treatment group was given HCQ on the basis of support treatment. The clinical data of the patients were analyzed, with comparisons made at baseline and during the six-month follow-up period. Any adverse reactions were recorded. Results: The baseline data were comparable between the HCQ treatment group and the control group. At the end of the six-month follow-up period, the reductions in urine protein excretion and serum PLA₂R antibody titer were more notable in the HCQ treatment group than those in the control group, with these differences being statistically significant (p<0.05). Compared to the control group, the HCQ treatment group had fewer patients who were converted from low risk to moderate-to-high risk (p=0.084). There were also no severe adverse reactions in the HCQ treatment group. Conclusion: In patients with low risk PLA₂R-associated MN, adequate supportive therapy combined with HCQ is superior to supportive therapy alone in terms of controlling proteinuria, reducing serum PLA₂R antibody titers, and lowering the probability of conversion from low risk to moderate-to-high risk. In addition, our study demonstrated that the incidence of adverse reactions did not increase. Trial registration: This study was registered in the Chinese Clinical Trial Registry (Registration No.: ChiCTR1900021757，Date of registration: 2019-03-08).