Takarazuka, Japan
Takarazuka, Japan

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PubMed | Nakayamadera Imai Clinic, Showa University, Tohoku University, Kaken Co. and 20 more.
Type: Journal Article | Journal: Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research | Year: 2016

We investigated the efficacy, safety, and clinical significance of trafermin, a recombinant human fibroblast growth factor (rhFGF)-2, for periodontal regeneration in intrabony defects in Phase III trials. Study A, a multicenter, randomized, double-blind, placebo-controlled study, was conducted at 24 centers. Patients with periodontitis with 4-mm and 3-mm or deeper probing pocket depth and intrabony defects, respectively, were included. A total of 328 patients were randomly assigned (2:1) to receive 0.3% rhFGF-2 or placebo, and 323 patients received the assigned investigational drug during flap surgery. One of the co-primary endpoints, the percentage of bone fill at 36 weeks after drug administration, was significantly greater in the rhFGF-2 group at 37.131% (95% confidence interval [CI], 32.7502 to 41.5123; n = 208) than it was in the placebo group at 21.579% (95% CI, 16.3571 to 26.8011; n = 100; p < 0.001). The other endpoint, the clinical attachment level regained at 36 weeks, was not significantly different between groups. Study B, a multicenter, randomized, blinded (patients and evaluators of radiographs), and active-controlled study was conducted at 15 centers to clarify the clinical significance of rhFGF-2. Patients with 6-mm and 4-mm or deeper probing pocket depth and intrabony defects, respectively, were included. A total of 274 patients were randomly assigned (5:5:2) to receive rhFGF-2, enamel matrix derivative (EMD), or flap surgery alone. A total of 267 patients received the assigned treatment during flap surgery. The primary endpoint, the linear alveolar bone growth at 36 weeks, was 1.927 mm (95% CI, 1.6615 to 2.1920; n = 108) in the rhFGF-2 group and 1.359 mm (95% CI, 1.0683 to 1.6495; n = 109) in the EMD group, showing non-inferiority (a prespecified margin of 0.3 mm) and superiority of rhFGF-2 to EMD. Safety problems were not identified in either study. Therefore, trafermin is an effective and safe treatment for periodontal regeneration in intrabony defect, and its efficacy was superior in rhFGF-2 compared to EMD treatments.


PubMed | Fukuoka University, Juntendo University, Hiroshima Kidney Organization, Nakayamadera Imai Clinic and 11 more.
Type: | Journal: Clinical and experimental nephrology | Year: 2016

We designed a prospective and randomized trial of mizoribine (MZR) therapy combined with prednisolone (PSL) for idiopathic membranous nephropathy (IMN) with steroid-resistant nephrotic syndrome (SRNS).Patients with IMN were divided into 2 groups, and MZR combined with PSL was administered for 2years. PSL was initially prescribed at 40mg/day and tapered. MZR was given once-a-day at 150mg and 3-times-a-day at 50mg each to groups 1 and 2. Serum MZR concentrations from 0 to 4h after administration were examined within one month of treatment. The concentration curve and peak serum level (C At 2years, 10 of 19 patients (52.6%) in group 1 and 7 of 18 patients (38.9%) in group 2 achieved complete remission (CR). The time-to-remission curve using the Kaplan-Meier technique revealed an increase in the cumulative CR rate in group 1, but no significant difference between the groups. Meanwhile, there was a significant difference in C Administration of MZR once a day is useful when combined with PSL for treatment of IMN with SRNS. In addition, it is important to assay the serum concentration of MZR and to determine C


Imai E.,Nakayamadera Imai Clinic | Haneda M.,Asahikawa University | Yamasaki T.,Daiichi Sankyo | Kobayashi F.,Daiichi Sankyo | And 4 more authors.
Hypertension Research | Year: 2013

Combination therapy with angiotensin II receptor blockers and angiotensin-converting enzyme inhibitors (ACEIs) requires further evaluation in patients with diabetic nephropathy and hypertension. In a post hoc analysis of the Olmesartan Reducing Incidence of Endstage renal disease in diabetic Nephropathy Trial with hypertension, we examined the effects of olmesartan on renal and cardiovascular outcomes in the presence or absence of an ACEI. Among 563 patients randomized to receive either olmesartan (n=280) or placebo (n=283), 73.5% (n=414) received a concomitant ACEI. Compared with placebo, olmesartan significantly reduced proteinuria in both the ACEI-treated and non-ACEI-treated groups. The respective changes in the urinary protein creatinine ratio in the olmesartan-treated and placebo-treated groups were -32.6% and +21.1% without an ACEI (P=0.001) and -17.0% and +2.2% with an ACEI (P=0.028). In the olmesartan group, 115 patients developed primary renal outcomes (41.1%) compared with 129 (45.6%) in the placebo group (hazard ratio (HR): 0.97, P=0.787). The respective HRs in the ACEI-treated and non-ACEI-treated groups were 1.02 (P=0.891) and 0.84 (P=0.450). 40 olmesartan-treated patients (14.3%) and 53 placebo-treated patients (18.7%) developed secondary cardiovascular outcomes (HR: 0.65, P=0.042). The respective HRs in the ACEI-treated and non-ACEI-treated groups were 0.69 (P=0.129) and 0.51 (P=0.129). Olmesartan was well tolerated. Dual blockade treatment caused more hyperkalemia than monotherapy. In patients with diabetic nephropathy and hypertension, olmesartan significantly reduced proteinuria, independent of ACEI treatment and cardiovascular outcome but failed to show additional renal benefit compared with ACEI treatment alone. The cardiovascular benefit of dual treatment requires further evaluation. © 2013 The Japanese Society of Hypertension All rights reserved.


PubMed | Tokyo Women's Medical University, Fukushima Medical University, Nakayamadera Imai Clinic, Showa University and 6 more.
Type: | Journal: Clinical and experimental nephrology | Year: 2016

Chronic kidney disease (CKD) eventually progresses to end-stage renal disease (ESRD). However, risk factors associated with CKD progression have not been well characterized in Japanese patients with CKD who are less affected with coronary disease than Westerners.A large-scale, multicenter, prospective, cohort study was conducted in patients with CKD and under nephrology care, who met the eligibility criteria [Japanese; age 20-75years; and estimated glomerular filtration rate (eGFR): 10-59mL/min/1.73m2966 patients (female, 38.9%; age, 60. 311.6years) were enrolled. The incidence of the primary endpoint increased significantly (P<0.0001) in concert with CKD stage at baseline. The multivariate Cox proportional hazards models revealed that elevated systolic blood pressure (SBP) [hazard ratio (HR) 1.203, 95% confidence interval (CI) 1.099-1.318)] and increased albumin-to-creatinine ratio (UACR1000mg/gCre; HR: 4.523; 95% CI 3.098-6.604) at baseline were significantly associated (P<0.0001, respectively) with the primary endpoint.Elevated SBP and increased UACR were risk factors that were significantly associated with CKD progression to ESRD in Japanese patients under nephrology care. UMIN clinical trial registry number: UMIN000020038.


PubMed | Tokyo Women's Medical University, Fukushima Medical University, Nakayamadera Imai Clinic, Showa University and 5 more.
Type: Journal Article | Journal: Kidney international | Year: 2016

The incidence of cardiovascular disease (CVD) is higher in patients with chronic kidney disease (CKD) than in the general population, and the risk of CVD increases with reductions in renal function. However, the incidence of CVD in Japanese patients with CKD has not been sufficiently investigated. To measure this we conducted the Chronic Kidney Disease Japan Cohort (CKD-JAC) Study over four years in 2,966 Japanese patients with CKD to examine the incidence of CVD and all-cause death. These patients had an estimated glomerular filtration rate (eGFR) of 10-59 ml/min/1.73 m


Horio M.,Osaka University | Imai E.,Nakayamadera Imai Clinic | Yasuda Y.,Nagoya University | Watanabe T.,Fukushima Medical University | Matsuo S.,Nagoya University
Clinical and Experimental Nephrology | Year: 2014

Background: Creatinine clearance (Ccr) overestimates glomerular filtration rate (GFR) due to the tubular secretion of creatinine. It is known that fractional excretion of creatinine (FE-Cr) increases with decreasing GFR. Association of serum albumin level with the tubular secretion of creatinine was also reported previously. Alteration of FE-Cr may affect the performance of GFR estimating equations based on serum creatinine. Therefore, we analyzed the factors influencing FE-Cr and compared the performance of GFR equations in subjects stratified by serum albumin levels. Methods: Seven hundred and fifty-seven Japanese subjects were included. GFR was measured by inulin renal clearance. GFR and Ccr were measured simultaneously. FE-Cr was calculated as the ratio of Ccr to GFR. Multivariate analysis was performed to evaluate the factors influencing FE-Cr. Age, gender, GFR, body mass index (BMI), body weight, height and serum albumin level were analyzed as the parameters. Estimated GFR was calculated by Japanese GFR equations based on serum creatinine (Eq-cr), serum cystatin C (Eq-cys) and 5 variables including serum albumin (Eq-5var). Results: FE-Cr in subjects with serum albumin <3.0, 3.0-3.9 and ≥4.0 g/dl were 1.63 ± 0.48, 1.53 ± 0.55, and 1.40 ± 0.36, respectively. FE-Cr in subjects with serum albumin <3.0 or 3.0-3.9 g/dl were significantly higher than the value in subjects with serum albumin ≥4.0 g/dl. Multivariate analysis showed that GFR (p < 0.0001) and serum albumin level (p = 0.004) were independent parameters affecting FE-Cr. Biases of Eq-cr, Eq-cys and Eq-5var in subjects with serum albumin <3.0 g/dl were -9.5 ± 17.5, -0.7 ± 17.1 and -0.6 ± 14.8 ml/min/1.73 m2, respectively. Eq-cr significantly overestimated GFR compared with Eq-cys or Eq-5var. Biases in subjects with serum albumin ≥4.0 g/dl were 6.4 ± 18.8, 2.0 ± 18.1 and 3.0 ± 18.3 ml/min/1.73 m2, respectively. Eq-cr significantly underestimated GFR compared with Eq-cys or Eq-5var. Conclusion: GFR and serum albumin level were independent parameters affecting FE-Cr. Alteration of FE-Cr according to the serum albumin levels may be one of the reasons of the bias of GFR equation based on serum creatinine. © 2013 Japanese Society of Nephrology.


Horio M.,Osaka University | Imai E.,Nakayamadera Imai Clinic | Yasuda Y.,Nagoya University | Watanabe T.,Fukushima Medical University | Matsuo S.,Nagoya University
Clinical and Experimental Nephrology | Year: 2013

Background: Japanese GFR equations based on serum creatinine (Scr) (Eq cr), serum cystatin C (Scys) (Eqcys) and average value of Eqcr and Eqcys (Eqaverage), and coefficient-modified CKD-EPI equations based on Scr (CKD-EPIcr), Scys (CKD-EPIcys) and Scys in combination with Scr (CKD-EPI cr-cys) are now available for Japanese subjects. Performance of these equations has not been well evaluated in subjects stratified by GFR. Therefore, the bias, precision and accuracy of the GFR equations were compared in Japanese subjects stratified by measured GFR. Methods: Three hundred fifty Japanese subjects were included for validation. These subjects were stratified by measured GFR (0-29, 30-59, 60-89, 90-119 ml/min/1.73 m2 and total). Japanese equations (Eqcr, Eqcys and Eqaverage) were compared with coefficient-modified CKD-EPI equations (0.813 × CKD-EPIcr, CKD-EPIcys and 0.908 × CKD-EPI cr-cys), respectively. GFR was measured by inulin renal clearance. Standardized Scr was measured by enzymatic method. Standardized Scys was measured by colloidal gold immunoassay. Results: Bias and accuracy were not significantly different between Japanese GFR equations and coefficient-modified CKD-EPI equations in all mGFR ranges. The precision of Eqcr was significantly better in GFR 0-29 ml/min/1.73 m2 and significantly worse in GFR 60-89 and GFR 90-119 ml/min/1.73 m2 compared with 0.813 × CKD-EPIcr. The precision of Eqcys was significantly better in GFR 30-59 and GFR 60-89 ml/min/1.73 m2 compared with CKD-EPIcys. The precision of Eqaverage was significantly better in GFR 30-59 ml/min/1.73 m2 and significantly worse in GFR 90-119 ml/min/1.73 m2 compared with 0.908 × CKD-EPIcr-cys. Conclusion: Japanese GFR equations performed well in subjects with GFR under 60 ml/min/1.73 m2 compared with the coefficient-modified CKD-EPI equations. © 2012 Japanese Society of Nephrology.


Wada T.,University of Tokyo | Nangaku M.,University of Tokyo | Maruyama S.,Nagoya University | Imai E.,Nakayamadera Imai Clinic | And 14 more authors.
Kidney International | Year: 2014

Elevated serum-soluble urokinase receptor (suPAR) levels have been described in patients with focal segmental glomerulosclerosis (FSGS) in several different cohorts. However, it remains unclear whether this is the case for Japanese patients and whether circulating suPAR can be clinically useful as a diagnostic marker. To determine this, we measured serum suPAR levels in 69 Japanese patients with biopsy-proven glomerular diseases in a cross-sectional manner. The serum suPAR levels showed a significant inverse correlation with renal function by univariate (R 2 of 0.242) and multivariate (β=0.226) analyses. Even after excluding patients with renal dysfunction, no significant difference in the suPAR levels was detected among the groups. Receiver operating characteristic analysis and measures of the diagnostic test performance showed that suPAR was not a useful parameter for differentiating FSGS from the other glomerular diseases (AUC-ROC: 0.621), although a small subgroup analysis showed that patients with FSGS, treated with steroids and/or immunosuppressants, had significantly lower suPAR levels. Patients with ANCA-associated glomerulonephritis had significantly higher levels of suPAR compared with the other disease groups, which may be owing to their lower renal function and systemic inflammation. Thus, suPAR levels are significantly affected by renal function and have little diagnostic value even in patients with normal renal function. © 2013 International Society of Nephrology.


Akiyama S.',Nagoya University | Akiyama M.,Nagoya University | Imai E.,Nakayamadera Imai Clinic | Ozaki T.,Nagoya University | And 2 more authors.
Clinical and Experimental Nephrology | Year: 2015

Background: Membranous nephropathy (MN) is the leading cause of nephrotic syndrome in adults. Anti-M-type phospholipase A2 receptor (anti-PLA2R) antibodies are found in most patients with idiopathic MN (iMN) worldwide, but the prevalence of anti-PLA2R antibodies among Japanese patients with MN is unknown. In this study, we determined the prevalence of anti-PLA2R antibodies in Japanese patients with MN. Methods: The study population of our retrospective cross-sectional consisted of 131 patients with biopsy-proven MN who had not received any immunosuppressive treatments at time of both renal biopsy and serum sample collection. Of these, 100 had iMN and 31 had secondary MN (sMN). The circulating anti-PLA2R antibodies were analyzed using a highly sensitive Western blot analysis. Analysis was performed under non-reducing conditions with a human glomerular extract at serum dilutions of 1:25, 1:10, and 1 as the primary antibody. Results: Anti-PLA2R antibodies were detected in 53 (53 %) of 100 patients with iMN and 0 (0 %) of 31 patients with sMN. The prevalence of anti-PLA2R antibodies was higher in patients with nephrotic syndrome (61 %) than in patients without nephrotic syndrome (43 %). The number of patients with serum albumin ≤3.0 g/dL was significantly higher in those with anti-PLA2R antibodies (92 %) than that in those without them (68 %). Conclusions: Anti-PLA2R antibodies were found in Japanese patients with iMN; however, the prevalence was lower than that of any other Asian country. This may indicate that the presence of other pathogenic antigens plays a significant role in Japanese patients with iMN. © 2014, The Author(s).


PubMed | Welch Center for Prevention, Yaizu City Hospital, Kyowa Hakko Kirin Co., Tokai University and Nakayamadera Imai Clinic
Type: Journal Article | Journal: Kidney international | Year: 2016

Predominantly based on North American and European studies, 30% to 40% declines in estimated glomerular filtration rate (eGFR) over a few years are strongly associated with the risk of end-stage renal disease (ESRD) and have been proposed as surrogate endpoints of ESRD for clinical research. However, this association has not been systematically quantified in Asian populations. To do this we studied adult Japanese patients with baseline eGFR 10-59 ml/min/1.73m

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