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BackgroundTreatments with glucocorticoids or immunosuppressants in IgA nephropathy remain controversial, especially in IgA nephropathy patients with renal insufficiency and small quantities of proteinuria. So far, no randomized controlled study has investigated whether cyclophosphamide has a protective effect on IgA nephropathy independent of glucocorticoids.MethodsWe conducted a single-center, randomized, controlled trial ((NCT01758120)). 135 IgA nephropathy patients with elevated plasma creatinine concentrations (1.3-3.0 mg/dl in males and 1.0-3.0 mg/dl in females), regardless of proteinuria level, were enrolled in and randomized 1:1 to the prednisone alone group or prednisone plus cyclophosphamide group. The daily dosage of oral prednisone was initiated at 0.5 mg/kg/d taken every morning for 2 months and then tapered by 20% each month for the next 4 months in prednisone alone group. In prednisone plus cyclophosphamide group cyclophosphamide was given in monthly pulses of 1.0 g for 6 months, while the prednisone dosage was the same as prednisone group. The two primary end points were a combination of reaching end-stage renal disease (ESRD) or doubling of serum creatinine or death and absolute changes in eGFR (estimated glomerular filtration rate) at 36 months.ResultsOverall, 135 patients were enrolled in our study. There was no significant difference between the two groups at baseline. The two groups had similar primary composite renal outcomes, which occurred in 4 participants (5.97%) in the prednisone alone group and 5 (7.35%) in the prednisone plus cyclophosphamide group (hazard ratio, 1.13 [95% CI, 0.30 to 4.19]; P = 0.861). Additionally, no significant difference in eGFR absolute change in three years was found between the two groups (0.09 (-7.42, 12.00) ml/min/1.73 m2 in the prednisone alone group vs. 3.24 (5.025, 9.59) ml/min/1.73 m2 in the prednisone plus cyclophosphamide group; P = 0.578). Proteinuria was reduced similarly in both groups. Treatment with cyclophosphamide led to more adverse events.ConclusionsOur study showed that corticosteroids plus cyclophosphamide did not increase the renal benefit of patients with advanced-stage IgA nephropathy but increased adverse effects compared with corticosteroids alone. Trial registration: ClinicalTrials.gov, NCT01758120. Registered 1 July 2012, https://clinicaltrials.gov/ct2/show/NCT01758120

Background Idiopathic membranous nephropathy (IMN) is frequently coexisted with diabetes mellitus (DM). Few researches investigate clinical outcomes in IMN patients coexisting diabetes mellitus (DM), including remission rates, renal survival and complications. Concurrent DM also pose therapeutic challenges to IMN patients due to the influence of glucocorticoids and immunosuppressant on metabolic disorders. We performed this study to investigate the impact of DM on clinical outcomes in IMN and the influence of therapeutic regime on metabolic parameters in diabetic IMN patients. Methods Two hundred and six adult hospitalized patients diagnosed with biopsy-proven IMN were retrospectively studied, including 42 patients coexisted with DM. Clinical outcomes including remission rates, renal outcome and complications were compared between groups. Impact of cyclophosphamide and ciclosporin on metabolism and complications were analyzed in IMN patients coexisting DM. Results IMN patients coexisted with DM were presented with advanced age, lower level of eGFR and hemoglobin. Patients coexisted with DM experienced worse renal function deterioration and higher incidence of infection. COX regression analysis showed that DM was an independent risk factor for renal function deterioration in IMN patients. There was no significant difference in remission rates and incidence of venous thromboembolism between two groups. Further exploration on the impact of therapeutic regimens on complications and metabolism showed that cyclophosphamide and ciclosporin had no significant difference in incidence of complications including infection and venous thromboembolism, and posed comparable influences on blood glucose, uric acid and blood lipids in IMN patients coexisted with DM. Conclusion Coexisting DM was an independent risk factor for renal function deterioration in IMN patients but did not influence the remission of proteinuria. Glucocorticoids in combination with cyclophosphamide or ciclosporine had similar impact on complications and metabolic index including blood glucose, uric acid and blood lipids in IMN patients coexisted with DM.

Background Recommended regular saline flushing presents clinical ineffectiveness for hemodialysis (HD) patients at high risk of bleeding with heparin contraindication. Regional citrate anticoagulation (RCA) has previously been used with a Ca2+ containing dialysate with prefiltered citrate in one arm (RCA-one). However, anticoagulation is not always achievable and up to 40% results in serious clotting in the venous expansion chamber. In this study, we have transferred one-quarter of the TSC from the prefiltered to the post filter based on RCA-one, which we have called RCA-two. The objective of this study was to compare the efficacy and safety of RCA-two with either saline flushing or RCA-one in HD patients with a high bleeding risk. Method In this investigator-initiated, multicenter, controlled, prospective, randomized clinical trial, 52 HD patients (77 sessions) were randomized to the RCA-2 and RCA-one group in part one of the trial, and 45 patients (64 sessions) were randomized to the RCA-2 and saline group in part two of the trial. Serious clotting events, adverse events and blood analyses were recorded. Results Serious clotting events in the RCA-two group were significantly lower compared with the RCA-one and saline group (7.89% vs. 30.77%, P = 0.011; 3.03% vs. 54.84%, P P P = 0.003) in the saline group. The majority of the AEs were hypotension, hypoglycemia and chest tightness, most of which were mild in intensity. Eight patients (20.51%) in the RCA-one group, 4 patients (12.90%) in the saline group and 10 patients (26.31%) in the RCA-two group, P > 0.05. Conclusions Our data demonstrated that the modified anticoagulation protocol was more effective and feasible during hemodialysis therapy for patients at high risk of bleeding. Trial registration GDREC, GDREC2017250H. Registered February 2, 2018; retrospectively registered.