Establishment of quality management system (QMS) plays a critical role in the clinical data management (CDM). The objectives of CDM are to ensure the quality and integrity of the trial data. Thus, every stage or element that may impact the quality outcomes of clinical studies should be in the controlled manner, which is referred to the full life cycle of CDM associated with the data collection, handling and statistical analysis of trial data. Based on the QMS, this paper provides consensus on how to develop a compliant clinical data management plan (CDMP). According to the essential requirements of the CDM, the CDMP should encompass each process of data collection, data capture and cleaning, medical coding, data verification and reconciliation, database monitoring and management, external data transmission and integration, data documentation and data quality assurance and so on. Creating and following up data management plan in each designed data management steps, dynamically record systems used, actions taken, parties involved will build and confirm regulated data management processes, standard operational procedures and effective quality metrics in all data management activities. CDMP is one of most important data management documents that is the solid foundation for clinical data quality.

Objective To identify the outcome of pregnancy and the alteration of renal function in women with nephrotic syndrome. Methods From 2003 to 2007, 59 pregnant women with nephrotic syndrome in our hospital were enrolled in the study. Their clinical data were retrospectively analyzed, including the time of kidney disease onset, 24-hour proteinuria, serum albumin, serum creatinine, blood uric acid, blood pressure, fetal survival, fetal mortality, rate of premature delivery, birth weight of the newborn, and proteinuria, renal function, blood pressure of the patients during their postpartum follow-up. Logistic regression analysis was used to identify the risk factors influencing the outcome of the patients and the newborns. Results The average gestational week was (20.35±9.40) weeks when proteinuria was detected in these pregnant women. The 24-hour proteinuria ranged from 3.5 to 15 g/24 h (median 5.1 g/24 h). The serum albumin was between 10 and 28 g/L (median 22.5 g/L). The serum creatinine was between 32 and 825 μmol/L (median 84 μmol/L) and the serum uric acid ranged from 196 to 793 μmol/L (median 385.5 μmol/L). Pregnancy-induced hypertension syndrome occurred in 75% of the patients, among whom 55.5% suffered from preeclampsia. Forty-three (72.9%) newborns survived , among whom 76.7% (33/43) were premature births and 62.8% (27/43) were low birth weight infants. 50% of the pregnant women still had nephrotic syndrome after delivery. 75% of 24 patients with pre-existing chronic glomerulonephritis had increased proteinuria during pregnancy. Among the 38 patients with renal insufficiency, 36.8% had poorer renal function after delivery. 23.7% of the patients progressed into end stage renal failure after delivery, 80% of whom had serum creatinine ≥ 265 μmol/L. 89% of the patients had persistent hypertension after childbirth. The Logistic regression analysis indicated hyperuricemia during pregnancy (P=0.018, OR=1.012) and the increase of serum creatinine (P=0.039, OR=1.005) were risk factors of renal failure in pregnant women after delivery. Hyperuricemia (P=0.012, OR=1.006)was the risk factor of fetal death. Conclusions Pregnancy with nephrotic syndrome leads to a low fetal survival. Hyperuricemia is the most important risk factor of the poor outcome of pregnant women and newborn.

Objective To compare the efficacy between the two-cuff swan neck catheter and the Tenckhoff catheter in continuous ambulatory peritoneal dialysis (CAPD) patients prospectively. Methods One hundred and ten patients with end-stage renal disease (ESRD) were selected as candidates, who received catheter implantation and CAPD therapy for the first time. Patients were divided into group A (swan neck catheter group) and group B (Tenckhoff catheter group), 55 patients for each group. Catheters of beth groups had a straight end and were implanted by routine surgical procedure. One-year follow-up was performed and information was recorded such as complications, survival time, quit of dialysis, death, etc. Survival analysis was carried out by Kaplan-Meier method and Log-Rank tests. Results At the end of follow-up, 17 patients died, 3 received renal transplantation, 8 were transferred to hemodialysis, 3 went to other hospitals, and 79 patients (71.8%) remained in our department for CAPD. Twenty-six patients of both groups had peritonitis with a total of 35 occurrences. The total incidence of peritonitis was 0.32 times/patient year, with the detailed figure of 0.35 times/patient year for group A and 0.29 times/patient year for group B respectively (P0.05). The time interval between the catheter implanting and the onset of peritonitis was (30±29) weeks and (29±24) weeks for group A and group B respectively (P0.05). The risk of developing peritonitis in both groups was 26.97% within 1 year. Tunnel infection occurred in 2 patients and exit-site infections in 9 patients of two groups. The incidence of tunnel plus exit-site infections was 0.1 times/patient year. Incidence of tunnel infection and the exit-site infection for group A was lower than that of group B (0 vs 0.036 times/patient year and 0.06 times/patient year vs 0.11 times/patient year respectively). However, the difference was not significant (P0.05). Mechanical complications of catheter (catheter migration, omcntum wrapping, leakage of peritoneal dialysates, slip out of outer cuff), incidence of inguinal hernia and bellyache between two groups were not significantly different (P0.05). There were 4 cases of catheter drawing in each group. Both two groups had the same 12-month technical survival rate as 92.73%. Of 17 dead cases, 7 were in group A and 10 in group B (P0.05). The main death causes were cardiocerebral events (47.1%) and infections (23.5%). The 12-month survival rate was 86.34% for group A and 80.68% for group B (P0.05). Conclusions There are no significant differences of infection, mechanical complications, technical survival rate and patients' survival rate between two groups. The efficacy of swan-neck catheter is similar to Tenckhoff catheter in CAPD patients.

Objective To evaluate the functional magnetic resonance (MR) imaging in the assessment of renal involvement and pathological changes in patients with lupus nephritis (LN).Methods Seventeen patients with LN and 10 healthy controls underwent coronal echo-planar diffusion-weighted (DW) MR imaging and blood oxygen level dependent (BOLD) MR imaging of the kidneys with a single breath-hold time of 16 s.The apparent diffusion coefficient (ADC) and R2* value of the kidneys were calculated with high b values (b=500 s/mm2).The correlation between the renal injury variables and the ADCs or R2* values was evaluated.Results The mean ADC value of kidneys in patients with LN was (2.43+0.24)×10-3 mm2/s,the mean R2* values of the renal cortex and medulla were (11.72+2.35)/s and (13.07+2.35)/s respectively,which were all significantly lower than those in volunteers (P=0.045,P=0.048and P=0.001,respectively).In the patients with LN,the mean ADC values were positively correlated with estimated glomerular filtration rate (eGFR) (r=0.558,P＜0.05).There was a negative correlation between the ADC values of the right kidneys and pathological chronic indexes (r=-0.493,P＜0.05).Moreover,the R2*values of the renal medulla were negatively correlated with 24 hours proteinuria,serum creatinine,pathological active indexes.The patients were assigned to group A (class Ⅲ,Ⅳ,Ⅴ,n=8) and group B class Ⅴ + Ⅲ and Ⅴ + Ⅳ,n=9).The tubulointerstitial lesions in group B were more severe than those in group A,while the mean ADC values and R2* values of the renal cortex in group B were lower as compared to group A.Conclusion DW MR imaging and BOLD MR imaging may be used to non-invasively monitor the disease activity and evaluate the efficacy in lupus nephritis.

Objective To evaluate the efficacy and safety of REXEEDTM series highflux dialyzer. Methods A randomized cross-over study of 3×3 Latin square was designed based on the surface area of dialyzer membrane (1.5 m2 and 2.1 m2). Seventy-two stable maintenance hemodialysis (MHD) patients from Shanghai Renji Hospital and Ruijin Hospital were enrolled in this study for 3 consecutive weeks. REXEEDTM-15AC, 15UC, 21AC, 21UC dialyzers were used as trial group and APS-15U,BIO-HX100 dialyzers were used as control group. The clearances of urea, creatinine, phosphorus and β2-microglobulin were calculated. Adverse event and adverse reactions were recorded. Results There were significantly higher urea and creatinine clearance in 1SAC and 15UC dialyzers as compared to APS-15U dialyzer [(222.07±18.74) mi/min, (220.23±26.26) ml/min vs (199.56±14.21) ml/min; (176.73±16.41) ml/min, (175.22±25.94) ml/min vs (165.42±14.68) ml/min, all P<0.05]. There were significantly higher urea, creatinine and β2-microglobulin clearance in 21AC and 21UC dialyzer as compared to BIO-HX100 dialyzer [(230.59±15.24) ml/min, (233.96±7.06) ml/min vs (203.43±36.66) ml/min; (183.50±25.90) ml/min, (181.05±23.94) ml/min vs (166.25±29.82) ml/min; (111.77±53.42) ml/min, (125.54±51.99) ml/min vs (42.39±4.81) ml/min; all P<0.05]. There was no significant difference of phosphorus clearance between REXEEDTM series dialyzers and control dialyzers. The efficiency of urea clearance and urea reduction ratio could achieve clinical targets in REXEEDTM series. Conclusion REXEEDTM series highflux dialyzers are effective and safe for clinical application.

Objective To evaluate the detection of alpha 5 (Ⅳ) collagen chain of skin basement membrane in diagnosis of Alport syndrome among suspected patients. Methods Data of suspected patients with the detection of alpha 5 (Ⅳ) collagen chain of skin basement membrane were retrospectively collected and analyzed from January 2007 to March 2008. Results A total of 254 suspected patients ranged from 1 to 71 years old with an average age of (25.85±17.03) years old were enrolled (male/female ratio, 0.76). There was no significant difference in average age between male and female. Abnormal alpha 5 (Ⅳ) collagen chain expression of skin basement membrane was found by indirect immunofluorescense in 19 patients among whom 12 cases were negative and 7 cases were diseontinous deposit. These 19 patients were diagnosed as Alport syndrome and the diagnostic rate was 7.5%. Conclusions The diagnostic rate of Alport syndrome by detection of alpha 5 (Ⅳ) collagen chain in skin basement membrane is significant and helpful for early and differential diagnosis of Alport syndrome.

Objective To analyze the causes and clinical features of 20 patients with hemolytic uremic syndrome (HUS) in order to improve the prognosis. Methods Twenty patients with HUS hospitalized in our department during July 1998 to December 2004 were enrolled in this study. The etiology, clinical features, individualized therapy and prognosis were retrospectively analyzed. Results These 20 HUS patients (18 HUS patients complicated with ARF) accounted for 2.48% of total patients with acute renal failure (ARF) in our hospital. There were 16 females and 4 males with mean age of (49.11±19.85) years. Five patients were idiopathic HUS and the other 15 were secondary HUS (10 SLE-associated HUS, 2 pregnancy-associated HUS, 1 APS-associated HUS, 1 renal arterioles sclerosis-associated HUS and 1 drug-associated HUS). Eighteen cases had ARF and 15 had nephrotic syndrome. Hypertension was found in 17 patients, among them 4 had malignant hypertension. Twelve patients had gross hematuria and the other 8 had microscopic hematuria. Diarrhea was found only in 1 patient. At onset, mean serum creatinine was (504.40±381.10) μmol/L and 24-h proteinuria was (5.0±2.6) g. Renal biopsy was pedormed in 16 patients. Fourteen patients received hemopurification therapy: 2 patients plasma exchange (PE); 8 patients PE combined with CVVHDF and /or HD; 4 patients CVVHDF and HD. Seven cases were treated with intravenous immunoglobulin (IVIg). Patients with SLE-associated HUS received the corticosteroids and immunosuppressants. Low or middle dosage of corticosteroids( 10-40 mg/d) was administered in patients with idiopathic HUS. For patients with APS, low molecular weight heparin was used. HUS patients were followed-up for average (46.0±32.8) months. During follow-up, 4 patients died, 11 recovered from renal insufficiency, 4 progressed to end stage renal failure of whom 2 depended on dialysis and 1 lost. The survival rates of SLE-associated HUS and none-SLE-associated HUS were 70% and 90%, and renal survival rates were 50% and 60% respectively, which were not significantly different between these two groups. Conclusions Most of the patients are secondary HUS. SLE-associated HUS is the main type of secondary HUS. The prognosis of SLE-associated HUS is poor. PE and IVIg are main therapy. Low dosage of corticosteroids can reduce relapse of HUS. Immunosuppressants can improve the prognosis.

Objective:To investigate the effects of rituximab on lymphocytes and immunoglobulin in the treatment of focal segmental glomerulosclerosis (FSGS) and minimal change disease (MCD).Methods:The subjects were FSGS and MCD patients admitted to Ruijin Hospital affiliated to Shanghai Jiaotong University on July 1, 2014 and July 1, 2019. All the enrolled patients were confirmed by clinical examination and renal biopsy, and received rituximab treatment (4 infusions of 375 mg/m 2 with the interval of 7-14 d). The levels of immunoglobulin IgA, IgG, IgM, and lymphocytes of CD19 +, CD20 +, CD3 +, CD3 +CD4 +, CD3 +CD8 + and natural killer cells (CD56 +CD16 +) were compared between baseline and the third month, the sixth month, the ninth month and the twelfth month after treatment. Results:Ninety-six patients with FSGS or MCD were enrolled in this study. The midian age was 28 years old (14-77 years old). The ratio of men to woman was 1.8∶1. There were 65 cases of MCD and 31 cases of FSGS. After rituximab treatment, the 24 h-proteinuria was significantly lower than that before treatment, and the serum albumin level was increased (both P<0.05). After rituximab treatment of 3 months, 6 months, 9 months and 12 months, CD19 + and CD20 + lymphocyte counts were significantly decreased (all P<0.01), and gradually recovered after 6 months. Compared with baseline, at 3, 6, 9, 12 months after rituximab treatment, the level of blood IgG was significantly increased ( P=0.004,<0.001,<0.001,<0.001, respectively), and the level of blood IgM was significantly decreased ( P<0.001, =0.008, =0.005,<0.001, respectively) but the median level still within the normal range (400-3 450 mg/L). The level of blood IgA was not significantly changed (all P<0.05). T lymphocytes (CD3 +, CD3 +CD4 + and CD3 +CD8 +) and natural killer cells (CD56 +CD16 +) showed no significant difference from baseline (all P>0.05). Conclusions:Rituximab can effectively eliminate CD19 + and CD20 + lymphocytes, and has little influence on peripheral blood lymphocyte count and immunoglobulin level except CD19 + and CD20 + lymphocytes. The standard administration of rituximab is safe for patients with FSGS and MCD.

ObjectiveToinvestigate the prevalence, awareness and risk factors of chronic kidney disease (CKD) among community adult population in Shanghai, China, in order to provide early diagnosis and treatment of CKD, and informations for national health policy makers.MethodsTwo thousand five hundred and ninety six residents (≥ 18 years old) were randomly selected from community population in Changning district of Shanghai, China. They were interviewed and tested for albuminuria -morning spot urine albumin to creatinine ratio [ACR, abnormal: ≥ 17 mg/g (male), ≥25 mg/g (female)], reduced renal function-estimated GFR by abbreviated MDRD equation [abnormal: <60 ml ·rain-1 (1.73 m2)-1] and hematuria-morning spot urine dipstick confirmed by urine microscopy. The associations among demographic characteristics, healthy characteristics (e.g. diabetes and hypertension) and indicators of kidney damage were examined. The investigators and neighborhood committee were well trained. Those who had semiquantitative positive were detected again by albuminuria-morniag spot urine albumin to creatinine ratio after three months. ResultsTwo thousand five hundred and fifty four residents with complete data were enrolled in the study. Albuminuria was detected in 6.3% of subjects, reduced renal function in 5.8%, hematuria in 1.2%. Approximately 11.8% of these subjects had at least one indicator of kidney damage. The awareness rate of CKD was 8.2%. The Logistic regression model showed that hyperuricemia, nephrolithiasis, anemia, diabetes, central obesity, hypertension and age contributed to the development of CKD. ConclusionsThe prevalence of CKD in community adult population in Shanghai is 11.8%, And the awareness rate of CKD is 8.2%. Hyperuricemia, nephrolithiasis, anemia, diabetes, central obesity, hypertension and age are risk factors of CKD.

Objective To compare the consistency between single-(I-GFR-SS) and dual-(I-GFR-DS) sample methods with three-sample method (I-GFR-TS) of iohexol plasma clearance in chronic kidney disease (CKD) patients for choosing the optimizing project of glomerular filtration rate (GFR) measurement.Methods The multiple-sample methods were performed in 174 patients with CKD admitted to the Department of Nephrology,Shanghai Ruijin Hospital from August 2017 to July 2018.Plasma concentrations of iohexol were measured three times at different time points after receiving 5 ml iohexol (300 g/L) intravenous injection,according to estimated GFR (eGFR) grouping.The first blood sample was collected at 2 hours,and the time for the last sample was delayed from 4 hours to 6 hours with reduction of eGFR.The synchronized Gates (99mTc-Gates-GFR) method was detected as control.With I-GFR-TS as the golden standard,the accuracies of I-GFR-DS,I-GFR-SS and 99mTc-Gates-GFR were compared.Results The median differences of I-GFR-DS,I-GFR-SS and 99mTc-Gates-GFR in overall patients were-0.15,-1.00,6.76 ml· min-1· (1.73 m2)-1 comparing with I-GFR-TS;P10(percentage of the GFRmeasurements that was within 10％ of the standard method) were 95.4％,74.1％,28.7％,and P30 were 100％,93.7％,72.4％ separately.In the patients with eGFR ＜ 30 ml· min-1· (1.73 m2)-1,I-GFR-SS was more accurate when last point collecting extended to 6 h from 4 h [P10:43.5％ vs 17.4％,P=0.055;P30:73.9％ vs 43.5％,P＜0.05].Conclusions The dual-sample plasma clearance of iohexol is recommended in clinical practice,and the single-sample method can be a secondary option because of its slightly poor accuracy but more convenient.Sample-collection protocol should be adjusted according to eGFR especially in moderate-to-severe CKD patients.The Gates method is not recommended.