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1. Guidelines for clinical evaluation of chronic kidney disease in early stages: AMED research on regulatory science of pharmaceuticals and medical devices

Author

Sugawara, Yuka, Kanda, Eiichiro, Hamano, Takayuki, Itano, Seiji, Okada, Hirokazu, Tomori, Koji, Watanabe, Yusuke, Asakura, Wataru, Isaka, Yoshitaka, Iseki, Kunitoshi, Usui, Tomoko, Suzuki, Yusuke, Tanaka, Mototsugu, Nishimura, Rimei, Fukami, Kei, Matsushita, Kunihiro, Wada, Jun, Watada, Hirotaka, Ueki, Kohjiro, Kashihara, Naoki, and Nangaku, Masaomi

Published
2024
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2. Hepatic arterial infusion of autologous CD34+ cells for hepatitis C virus-related decompensated cirrhosis: A multicenter, open-label, exploratory randomized controlled trial

Author

Nakamura, Toru, Masuda, Atsutaka, Kako, Makoto, Enomoto, Hirayuki, Kaibori, Masaki, Fujita, Yasuyuki, Tanizawa, Kyoko, Ioji, Tetsuya, Fujimori, Yoshihiro, Fukami, Kei, Hazama, Takuma, Iwamoto, Hideki, Kako, Yasukazu, Kobayashi, Kaoru, Koga, Hironori, Nagafuji, Koji, Ohtake, Takayasu, Suzuki, Hiroyuki, Takashima, Tomoyuki, Tsukiyama, Toshitaka, Uojima, Haruki, Yamahara, Kenichi, Yamakado, Koichiro, Yamamoto, Hidekazu, Yoh, Kazunori, Yoshihara, Satoshi, Kawamoto, Atsuhiko, Nishiguchi, Shuhei, Kobayashi, Shuzo, Torimura, Takuji, and Kawaguchi, Takumi

Published
2024
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8. Rationale and design of the Japanese Biomarkers in Nephrotic Syndrome (J-MARINE) study.

Author

Kurasawa, Shimon, Kato, Sawako, Ozeki, Takaya, Akiyama, Shin'ichi, Ishimoto, Takuji, Mizuno, Masashi, Tsuboi, Naotake, Kato, Noritoshi, Kosugi, Tomoki, Maruyama, Shoichi, Tamai, Hirofumi, Takeda, Asami, Shinjo, Hibiki, Arata, Hanayo, Naruse, Tomohiko, Watanabe, Tomoharu, Hiromura, Keiju, Fukami, Kei, Nakagawa, Naoki, and Akahori, Toshiyuki

Subjects
NEPHROTIC syndrome, BIOMARKERS, PLASMINOGEN activators, JAPANESE people, FOCAL segmental glomerulosclerosis, GLOMERULAR filtration rate
Abstract

Introduction: Disease subtyping and monitoring are essential for the management of nephrotic syndrome (NS). Although various biomarkers for NS have been reported, their clinical efficacy has not been comprehensively validated in adult Japanese patients. Methods: The Japanese Biomarkers in Nephrotic Syndrome (J-MARINE) study is a nationwide, multicenter, and prospective cohort study in Japan, enrolling adult (≥18 years) patients with minimal change disease (MCD), focal segmental glomerulosclerosis (FSGS), membranous nephropathy (MN), membranoproliferative glomerulonephritis (MPGN), C3 glomerulopathy (C3G), and lupus nephritis (LN). Baseline clinical information and plasma and urine samples will be collected at the time of immunosuppressive therapy initiation or biopsy. Follow-up data and plasma and urine samples will be collected longitudinally based on the designated protocols. Candidate biomarkers will be measured: CD80, cytotoxic T-lymphocyte antigen 4, and soluble urokinase plasminogen activator receptor for MCD and FSGS; anti-phospholipase A2 receptor and thrombospondin type-1 domain-containing protein 7A antibodies for MN; fragment Ba, C3a, factor I, and properdin for MPGN/C3G; and CD11b, CD16b, and CD163 for LN. Outcomes include complete and partial remission, relapse of proteinuria, a 30% reduction in estimated glomerular filtration rate (eGFR), eGFR decline, and initiation of renal replacement therapy. The diagnostic accuracy and predictive ability for clinical outcomes will be assessed for each biomarker. Results: From April 2019 to April 2023, 365 patients were enrolled: 145, 21, 138, 10, and 51 cases of MCD, FSGS, MN, MPGN/C3G, and LN, respectively. Conclusion: This study will provide valuable insights into biomarkers for NS and serve as a biorepository for future studies. [ABSTRACT FROM AUTHOR]

Published
2024
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10. Better remission rates in elderly Japanese patients with primary membranous nephropathy in nationwide real-world practice: The Japan Nephrotic Syndrome Cohort Study (JNSCS)

Author

Yokoyama, Hitoshi, Yamamoto, Ryohei, Imai, Enyu, Maruyama, Shoichi, Sugiyama, Hitoshi, Nitta, Kosaku, Tsukamoto, Tatsuo, Uchida, Shunya, Takeda, Asami, Sato, Toshinobu, Wada, Takashi, Hayashi, Hiroki, Akai, Yasuhiro, Fukunaga, Megumu, Tsuruya, Kazuhiko, Masutani, Kosuke, Konta, Tsuneo, Shoji, Tatsuya, Hiramatsu, Takeyuki, Goto, Shunsuke, Tamai, Hirofumi, Nishio, Saori, Shirasaki, Arimasa, Nagai, Kojiro, Yamagata, Kunihiro, Hasegawa, Hajime, Yasuda, Hidemo, Ichida, Shizunori, Naruse, Tomohiko, Fukami, Kei, Nishino, Tomoya, Sobajima, Hiroshi, Tanaka, Satoshi, Akahori, Toshiyuki, Ito, Takafumi, Terada, Yoshio, Katafuchi, Ritsuko, Fujimoto, Shouichi, Okada, Hirokazu, Ishimura, Eiji, Kazama, Junichiro James, Hiromura, Keiju, Mimura, Tetsushi, Suzuki, Satashi, Saka, Yosuke, Sofue, Tadashi, Suzuki, Yusuke, Shibagaki, Yugo, Kitagawa, Kiyoki, Morozumi, Kunio, Fujita, Yoshiro, Mizutani, Makoto, Shigematsu, Takashi, Furuichi, Kengo, Fujimoto, Keiji, Kashihara, Naoki, Sato, Hiroshi, Matsuo, Seiichi, Narita, Ichiei, and Isaka, Yoshitaka

Published
2020
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11. Development of a prognostic risk score to predict early mortality in incident elderly Japanese hemodialysis patients.

Author

Okada, Hirokazu, Ono, Atsushi, Tomori, Koji, Inoue, Tsutomu, Hanafusa, Norio, Sakai, Ken, Narita, Ichiei, Moriyama, Toshiki, Isaka, Yoshitaka, Fukami, Kei, Itano, Seiji, Kanda, Eiichiro, and Kashihara, Naoki

Subjects
DISEASE risk factors, PROPORTIONAL hazards models, HEMODIALYSIS patients, OLDER patients, OLDER people, EARLY death
Abstract

Background: Information of short-term prognosis after hemodialysis (HD) introduction is important for elderly patients with chronic kidney disease (CKD) and their families choosing a modality of renal replacement therapy. Therefore, we developed a risk score to predict early mortality in incident elderly Japanese hemodialysis patients. Materials and methods: We analyzed data of incident elderly HD patients from a nationwide cohort study of the Japanese Society for Dialysis Therapy Renal Data Registry (JRDR) to develop a prognostic risk score. Candidate risk factors for early death within 1 year was evaluated using multivariate logistic regression analysis. The risk score was developed by summing up points derived from parameter estimate values of independent risk factors. The association between risk score and early death was tested using Cox proportional hazards models. This risk score was validated twice by using an internal validation cohort derived from the JRDR and an external validation cohort collected for this study. Results: Using the development cohort (n = 2,000), nine risk factors were retained in the risk score: older age (>85), yes = 2, no = 0; sex, male = 2, female = 0; lower body mass index (<20), yes = 2, no = 0; cancer, yes = 1, no = 0; dementia, yes = 3, no = 0; lower creatinine (<6.5 mg/dL), yes = 1, no = 0; lower albumin (<3.0 g/dL), yes = 3, no = 0; normal or high calcium (≥8.5 mg/dL), yes = 1, no = 0; and higher C reactive protein (>2.0 mg/dL), yes = 2, no = 0. In the internal and external validation cohorts (n = 739, 140, respectively), the medium- and high-risk groups (total score, 6 to 10 and 11 or more, respectively) showed significantly higher risk of early death than the low-risk group (total score, 0 to 5) (p<0.001). Conclusion: We developed a prognostic risk score predicting early death within 1 year in incident elderly Japanese HD patients, which may help detect elderly patients with a high-risk of early death after HD introduction. [ABSTRACT FROM AUTHOR]

Published
2024
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13. Regional variations in immunosuppressive therapy in patients with primary nephrotic syndrome: the Japan nephrotic syndrome cohort study

Author

Yamamoto, Ryohei, Imai, Enyu, Maruyama, Shoichi, Yokoyama, Hitoshi, Sugiyama, Hitoshi, Nitta, Kosaku, Tsukamoto, Tatsuo, Uchida, Shunya, Takeda, Asami, Sato, Toshinobu, Wada, Takashi, Hayashi, Hiroki, Akai, Yasuhiro, Fukunaga, Megumu, Tsuruya, Kazuhiko, Masutani, Kosuke, Konta, Tsuneo, Shoji, Tatsuya, Hiramatsu, Takeyuki, Goto, Shunsuke, Tamai, Hirofumi, Nishio, Saori, Shirasaki, Arimasa, Nagai, Kojiro, Yamagata, Kunihiro, Hasegawa, Hajime, Yasuda, Hidemo, Ichida, Shizunori, Naruse, Tomohiko, Fukami, Kei, Nishino, Tomoya, Sobajima, Hiroshi, Tanaka, Satoshi, Akahori, Toshiyuki, Ito, Takafumi, Yoshio, Terada, Katafuchi, Ritsuko, Fujimoto, Shouichi, Okada, Hirokazu, Ishimura, Eiji, Kazama, Junichiro James, Hiromura, Keiju, Mimura, Tetsushi, Suzuki, Satashi, Saka, Yosuke, Sofue, Tadashi, Suzuki, Yusuke, Shibagaki, Yugo, Kitagawa, Kiyoki, Morozumi, Kunio, Fujita, Yoshiro, Mizutani, Makoto, Shigematsu, Takashi, Kashihara, Naoki, Sato, Hiroshi, Matsuo, Seiichi, Narita, Ichiei, and Isaka, Yoshitaka

Published
2018
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14. Effect of switching from cinacalcet to etelcalcetide on secondary hyperparathyroidism in patients undergoing hemodialysis: an ESCORT trial

Author

Kurokawa, Yuka, Kaida, Yusuke, Hazama, Takuma, Nakayama, Yosuke, Otome, Takaomi, Shibata, Ryo, Ito, Sakuya, Kodama, Goh, Nakamura, Nao, Kambe, Takatoshi, Moriyama, Tomofumi, Nagata, Akiko, Minami, Aki, Ando, Ryotaro, Wada, Yoshifumi, Sugiyama, Miki, Usui, Michiaki, Chiba, Michio, Moriyama, Atsuo, Ohara, Atsuko, Miyazaki, Hiroshi, Kakuma, Tatsuyuki, and Fukami, Kei

Published
2020
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20. Decline in estimated glomerular filtration rate is associated with risk of end-stage renal disease in type 2 diabetes with macroalbuminuria: an observational study from JDNCS

Author

Shimizu, Miho, Furuichi, Kengo, Toyama, Tadashi, Funamoto, Tomoaki, Kitajima, Shinji, Hara, Akinori, Ogawa, Daisuke, Koya, Daisuke, Ikeda, Kenzo, Koshino, Yoshitaka, Kurokawa, Yukie, Abe, Hideharu, Mori, Kiyoshi, Nakayama, Masaaki, Konishi, Yoshio, Samejima, Ken-ichi, Matsui, Masaru, Yamauchi, Hiroyuki, Gohda, Tomohito, Fukami, Kei, Nagata, Daisuke, Yamazaki, Hidenori, Yuzawa, Yukio, Suzuki, Yoshiki, Fujimoto, Shouichi, Maruyama, Shoichi, Kato, Sawako, Naito, Takero, Yoshimura, Kenichi, Yokoyama, Hitoshi, Wada, Takashi, and Research Group of Diabetic Nephropathy, the Ministry of Health, Labour, and Welfare of Japan and Japan Agency for Medical Research and Development

Published
2018
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28. Association of Baseline Renal Function with Mortality in Patients with Sepsis Requiring Continuous Renal Replacement Therapy for Acute Kidney Injury: A Single-Center Retrospective Study.

Author

Fukuda, Masafumi, Fukami, Kei, Nabeta, Masakazu, Hirayu, Nobuhisa, and Takasu, Osamu

Subjects
*ACUTE kidney failure, *RENAL replacement therapy, *KIDNEY physiology, *SEPTIC shock, *CHRONIC kidney failure, *KIDNEY diseases, *VEIN diseases
Abstract

Introduction: To date, the prognosis of patients with sepsis and underlying chronic kidney disease (CKD) had been poor. However, the impact of preseptic renal function on the short-term prognosis of patients with extremely severe septic shock with acute kidney injury (AKI) that requires renal replacement therapy (RRT) is unclear. Methods: Of the septic shock cases treated at the intensive care unit for ≥48 h, 131 adults who were diagnosed as septic AKI and underwent continuous venovenous hemodiafiltration were retrospectively analyzed. The relationships of demographic, clinical, and laboratory data with mortality were evaluated, and the independent risk factors for death were identified. Results: The median age of the subjects was 73 (range, 63–80) years, and 76 (58%) were men. The rate of mortality was significantly higher among patients with CKD (n = 42) than in those without CKD (n = 89) (43% vs. 22%, p < 0.016). On univariate and multivariate logistic regression analyses, the associated factors and independent predictors of death were Sequential Organ Failure Assessment score (odds ratios [ORs] 1.151, 95% confidence intervals [CIs] 1.026–1.293, p = 0.017, and OR 1.129, 95% CI 1.003–1.271, respectively); baseline estimated glomerular filtration rate (OR 0.986, 95% CI 0.975–0.997, p = 0.016, and OR 0.983, 95% CI 0.970–0.996, respectively); and lactic acid (OR 1.094, 95% CI 1.005–1.190, p = 0.038, and OR 1.110 CI 1.015–1.215, respectively). Conclusion: Reduced baseline renal function may be a factor for poor short-term prognosis in severe septic AKI cases requiring RRT. [ABSTRACT FROM AUTHOR]

Published
2023
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37. Quantification and Visualization of Reliable Hemodynamics Evaluation Based on Non-Contact Arteriovenous Fistula Measurement.

Author

Iwai, Rumi, Shimazaki, Takunori, Kawakubo, Yoshifumi, Fukami, Kei, Ata, Shingo, Yokoyama, Takeshi, Hitosugi, Takashi, Otsuka, Aki, Hayashi, Hiroyuki, Tsurumoto, Masanobu, Yokoyama, Reiko, Yoshida, Tetsuya, Hirono, Shinya, and Anzai, Daisuke

Subjects
ARTERIOVENOUS fistula, MEDIAN (Mathematics), BLOOD flow, SIGNAL-to-noise ratio, VISUALIZATION
Abstract

The condition of arteriovenous fistula (AVF) blood flow is typically checked by using auscultation; however, auscultation should require a qualitative judgment dependent on the skills of doctors, and further attention to contact infection is required. For these reasons, this study developed a non-contact and non-invasive medical device to measure the pulse wave of AVFs by applying optical imaging technology. As a first step toward realization of the quantification judgment based on non-contact AVF measurement, we experimentally validated the developed system, whereby the hemodynamics of 168 subjects were visually and quantitatively evaluated based on clinical tests. Based on the evaluation results, the fundamental statistical characteristics of the non-contact measurement, including the average and median values, and distribution of measured signal-to-noise power ratio, were demonstrated. The clinical test results contributed to the future construction of quantified criteria for the AVF condition with the non-contact measurement. [ABSTRACT FROM AUTHOR]

Published
2022
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46. Screening of Fabry disease in patients with chronic kidney disease in Japan.

Author

Nagata, Akiko, Nasu, Makoto, Kaida, Yusuke, Nakayama, Yosuke, Kurokawa, Yuka, Nakamura, Nao, Shibata, Ryo, Hazama, Takuma, Tsukimura, Takahiro, Togawa, Tadayasu, Saito, Seiji, Sakuraba, Hitoshi, and Fukami, Kei

Subjects
ANGIOKERATOMA corporis diffusum, CHRONIC kidney failure, CHRONICALLY ill, MEDICAL screening, AMINO acid residues, GLYCOGEN storage disease type II
Abstract

Background Fabry disease (FD), an X-linked lysosomal storage disorder caused by a deficiency in alfa-galactosidase A (α-Gal A) activity due to mutations in the GLA gene, has a prevalence of 0–1.69% in patients undergoing haemodialysis; however, its prevalence in patients with chronic kidney disease (CKD) Stages 1–5 is unknown. Methods Serum α-Gal A activity analysis and direct sequencing of GLA were used to screen for FD in 2122 male patients with CKD, including 1703 patients with CKD Stage 5D and 419 with CKD Stages 1–5. The correlation between serum α-Gal A activity and confounding factors in patients with CKD Stages 1–5 was evaluated. Results FD prevalence rates in patients with CKD Stage 5D and CKD Stages 1–5 were 0.06% (1/1703) and 0.48% (2/419), respectively. A patient with CKD Stage 5D exhibited a novel GLA mutation, p.Met208Arg, whereas two patients with CKD Stages 1–5 had c.370delG and p.Met296Ile. p. Met208Arg caused moderate structural changes in the molecular surface region near the substituted amino acid residue but did not affect the catalytic residues Asp170 and Asp231 in α-Gal A. Serum α-Gal A activity in patients with CKD Stages 1–5 was inversely correlated with age (P < 0.0001) but directly correlated with estimated glomerular filtration rate (P < 0.0001). Conclusions FD prevalence was much higher in male patients with CKD Stages 1–5 than in those with CKD Stage 5D. FD screening in patients with CKD Stages 1–5 may improve patient survival, decreasing the number of patients with CKD Stage 5D. [ABSTRACT FROM AUTHOR]

Published
2022
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50. Inhibitory effects of RAGE-aptamer on development of monocrotaline-induced pulmonary arterial hypertension in rats.

Author

Nakamura, Kazufumi, Akagi, Satoshi, Ejiri, Kentaro, Yoshida, Masashi, Miyoshi, Toru, Sakaguchi, Masakiyo, Amioka, Naofumi, Suastika, Luh Oliva Saraswati, Kondo, Megumi, Nakayama, Rie, Takaya, Yoichi, Higashimoto, Yuichiro, Fukami, Kei, Matsubara, Hiromi, and Ito, Hiroshi

Abstract

• RAGE-aptamer suppresses development of monocrotaline-induced pulmonary arterial hypertension (PAH) in rats. • Inhibition of RAGE ameliorates muscularization of small pulmonary arteries. • Treatment with RAGE-aptamer might be a new therapeutic option for PAH. The receptor for advanced glycation end products (RAGE), a transmembrane receptor belonging to the immunoglobulin superfamily, is overexpressed in pulmonary artery smooth muscle cells (PASMCs) in patients with pulmonary arterial hypertension (PAH) and is implicated in the etiology of PAH. Recently, we reported that RAGE-aptamer, a short and single-stranded DNA directed against RAGE, inhibited an inappropriate increase in cultured PASMCs in PAH. The aim of this study was to determine the efficacy of RAGE-aptamer in monocrotaline-induced PAH in rats. Rats were assigned to either an untreated control group, a group that received continuous subcutaneous administration of RAGE-aptamer immediately after monocrotaline injection, or a group that received control-aptamer immediately after monocrotaline injection. All rats survived 21 days after injection of monocrotaline and control-aptamer or RAGE-aptamer. Injection of monocrotaline with continuous subcutaneous delivery of control-aptamer resulted in higher right ventricular systolic pressure compared with controls. This increase was attenuated by continuous subcutaneous delivery of RAGE-aptamer. The proportion of small pulmonary arteries with full muscularization was greater in the monocrotaline and control-aptamer group than in the control group. Continuous subcutaneous delivery of RAGE-aptamer significantly reduced the percentage of small pulmonary arteries with full muscularization. Continuous subcutaneous delivery of RAGE-aptamer suppresses development of monocrotaline-induced PAH in rats. Inhibition of RAGE ameliorates muscularization of small pulmonary arteries. Treatment with RAGE-aptamer might be a new therapeutic option for PAH. [ABSTRACT FROM AUTHOR]

Published
2021
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