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215. Atrasentan and renal events in patients with type 2 diabetes and chronic kidney disease (SONAR): a double-blind, randomised, placebo-controlled trial

Author

UCL - SSS/IREC/NEFR - Pôle de Néphrologie, UCL - (SLuc) Service de néphrologie, Heerspink, Hiddo J L, Parving, Hans-Henrik, Andress, Dennis L, Bakris, George, Correa-Rotter, Ricardo, Hou, Fan-Fan, Kitzman, Dalane W, Kohan, Donald, Makino, Hirofumi, McMurray, John J V, Melnick, Joel Z, Miller, Michael G, Pergola, Pablo E, Perkovic, Vlado, Tobe, Sheldon, Yi, Tingting, Wigderson, Melissa, de Zeeuw, Dick, SONAR Committees and Investigators, Jadoul, Michel, UCL - SSS/IREC/NEFR - Pôle de Néphrologie, UCL - (SLuc) Service de néphrologie, Heerspink, Hiddo J L, Parving, Hans-Henrik, Andress, Dennis L, Bakris, George, Correa-Rotter, Ricardo, Hou, Fan-Fan, Kitzman, Dalane W, Kohan, Donald, Makino, Hirofumi, McMurray, John J V, Melnick, Joel Z, Miller, Michael G, Pergola, Pablo E, Perkovic, Vlado, Tobe, Sheldon, Yi, Tingting, Wigderson, Melissa, de Zeeuw, Dick, SONAR Committees and Investigators, and Jadoul, Michel

Abstract

BACKGROUND: Short-term treatment for people with type 2 diabetes using a low dose of the selective endothelin A receptor antagonist atrasentan reduces albuminuria without causing significant sodium retention. We report the long-term effects of treatment with atrasentan on major renal outcomes. METHODS: We did this double-blind, randomised, placebo-controlled trial at 689 sites in 41 countries. We enrolled adults aged 18-85 years with type 2 diabetes, estimated glomerular filtration rate (eGFR) 25-75 mL/min per 1·73 m2 of body surface area, and a urine albumin-to-creatinine ratio (UACR) of 300-5000 mg/g who had received maximum labelled or tolerated renin-angiotensin system inhibition for at least 4 weeks. Participants were given atrasentan 0·75 mg orally daily during an enrichment period before random group assignment. Those with a UACR decrease of at least 30% with no substantial fluid retention during the enrichment period (responders) were included in the double-blind treatment period. Responders were randomly assigned to receive either atrasentan 0·75 mg orally daily or placebo. All patients and investigators were masked to treatment assignment. The primary endpoint was a composite of doubling of serum creatinine (sustained for ≥30 days) or end-stage kidney disease (eGFR <15 mL/min per 1·73 m2 sustained for ≥90 days, chronic dialysis for ≥90 days, kidney transplantation, or death from kidney failure) in the intention-to-treat population of all responders. Safety was assessed in all patients who received at least one dose of their assigned study treatment. The study is registered with ClinicalTrials.gov, number NCT01858532. FINDINGS: Between May 17, 2013, and July 13, 2017, 11 087 patients were screened; 5117 entered the enrichment period, and 4711 completed the enrichment period. Of these, 2648 patients were responders and were randomly assigned to the atrasentan group (n=1325) or placebo group (n=1323). Median follow-up was 2·2 years (IQR 1·4-2·9). 79 (6·0%) of

Published
2019

216. Atrasentan and renal events in patients with type 2 diabetes and chronic kidney disease (SONAR):a double-blind, randomised, placebo-controlled trial

Author

Heerspink, Hiddo J.L., Parving, Hans Henrik, Andress, Dennis L., Bakris, George, Correa-Rotter, Ricardo, Hou, Fan Fan, Kitzman, Dalane W., Kohan, Donald, Makino, Hirofumi, McMurray, John J.V., Melnick, Joel Z., Miller, Michael G., Pergola, Pablo E., Perkovic, Vlado, Tobe, Sheldon, Yi, Tingting, Wigderson, Melissa, de Zeeuw, Dick, Elbert, Alicia, Vallejos, Augusto, Alvarisqueta, Andres, Maffei, Laura, Juncos, Luis, de Arteaga, Javier, Greloni, Gustavo, Farias, Eduardo, Zucchini, Alfredo, Vogel, Daniel, Cusumano, Ana, Santos, Juan, Fraenkel, Margaret, Gallagher, Martin, Davis, Tim, Acharya, Shamasunder, Cooke, Duncan, Suranyi, Michael, Roger, Simon, Toussaint, Nigel, Pollock, Carol, Chan, Doris, Stranks, Stephen, MacIsaac, Richard, Endre, Zoltan, Schmidt, Alice, Prager, Rudolf, Mayer, Gert, Warling, Xavier, Jadoul, Michel, Egstrup, Kenneth, Oczachowska-Kulik, Anna Ewa, Rossing, Peter, Ono, Yasuhirov, Yalcin, Murat, Karim, Shahana, Heerspink, Hiddo J.L., Parving, Hans Henrik, Andress, Dennis L., Bakris, George, Correa-Rotter, Ricardo, Hou, Fan Fan, Kitzman, Dalane W., Kohan, Donald, Makino, Hirofumi, McMurray, John J.V., Melnick, Joel Z., Miller, Michael G., Pergola, Pablo E., Perkovic, Vlado, Tobe, Sheldon, Yi, Tingting, Wigderson, Melissa, de Zeeuw, Dick, Elbert, Alicia, Vallejos, Augusto, Alvarisqueta, Andres, Maffei, Laura, Juncos, Luis, de Arteaga, Javier, Greloni, Gustavo, Farias, Eduardo, Zucchini, Alfredo, Vogel, Daniel, Cusumano, Ana, Santos, Juan, Fraenkel, Margaret, Gallagher, Martin, Davis, Tim, Acharya, Shamasunder, Cooke, Duncan, Suranyi, Michael, Roger, Simon, Toussaint, Nigel, Pollock, Carol, Chan, Doris, Stranks, Stephen, MacIsaac, Richard, Endre, Zoltan, Schmidt, Alice, Prager, Rudolf, Mayer, Gert, Warling, Xavier, Jadoul, Michel, Egstrup, Kenneth, Oczachowska-Kulik, Anna Ewa, Rossing, Peter, Ono, Yasuhirov, Yalcin, Murat, and Karim, Shahana

Abstract

Background: Short-term treatment for people with type 2 diabetes using a low dose of the selective endothelin A receptor antagonist atrasentan reduces albuminuria without causing significant sodium retention. We report the long-term effects of treatment with atrasentan on major renal outcomes. Methods: We did this double-blind, randomised, placebo-controlled trial at 689 sites in 41 countries. We enrolled adults aged 18–85 years with type 2 diabetes, estimated glomerular filtration rate (eGFR)25–75 mL/min per 1·73 m2 of body surface area, and a urine albumin-to-creatinine ratio (UACR)of 300–5000 mg/g who had received maximum labelled or tolerated renin–angiotensin system inhibition for at least 4 weeks. Participants were given atrasentan 0·75 mg orally daily during an enrichment period before random group assignment. Those with a UACR decrease of at least 30% with no substantial fluid retention during the enrichment period (responders)were included in the double-blind treatment period. Responders were randomly assigned to receive either atrasentan 0·75 mg orally daily or placebo. All patients and investigators were masked to treatment assignment. The primary endpoint was a composite of doubling of serum creatinine (sustained for ≥30 days)or end-stage kidney disease (eGFR <15 mL/min per 1·73 m2 sustained for ≥90 days, chronic dialysis for ≥90 days, kidney transplantation, or death from kidney failure)in the intention-to-treat population of all responders. Safety was assessed in all patients who received at least one dose of their assigned study treatment. The study is registered with ClinicalTrials.gov, number NCT01858532. Findings: Between May 17, 2013, and July 13, 2017, 11 087 patients were screened; 5117 entered the enrichment period, and 4711 completed the enrichment period. Of these, 2648 patients were responders and were randomly assigned to the atrasentan group (n=1325)or placebo group (n=1323). Median follow-up was 2·2 years (IQR

Published
2019

221. The Classification of Glomerulonephritis in Systemic Lupus Erythematosus Revisited

Author

Weening, Jan J., D’Agati, Vivette D., Schwartz, Melvin M., Seshan, Surya V., Alpers, Charles E., Appel, Gerald B., Balow, James E., Bruijn, Jan A., Cook, Terence, Ferrario, Franco, Fogo, Agnes B., Ginzler, Ellen M., Hebert, Lee, Hill, Gary, Hill, Prue, Jennette, J. Charles, Kong, Norella C., Lesavre, Philippe, Lockshin, Michael, Looi, Lai-Meng, Makino, Hirofumi, Moura, Luiz A., and Nagata, Michio

Published
2004
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225. Erratum to: Clinical impact of albuminuria and glomerular filtration rate on renal and cardiovascular events, and all-cause mortality in Japanese patients with type 2 diabetes

Author

Wada, Takashi, Haneda, Masakazu, Furuichi, Kengo, Babazono, Tetsuya, Yokoyama, Hiroki, Iseki, Kunitoshi, Araki, Shin-ichi, Ninomiya, Toshiharu, Hara, Shigeko, Suzuki, Yoshiki, Iwano, Masayuki, Kusano, Eiji, Moriya, Tatsumi, Satoh, Hiroaki, Nakamura, Hiroyuki, Shimizu, Miho, Toyama, Tadashi, Hara, Akinori, Makino, Hirofumi, and The Research Group of Diabetic Nephropathy, Ministry of Health, Labour, and Welfare of Japan

Published
2014
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240. Serum galectin-9 levels are elevated in the patients with type 2 diabetes and chronic kidney disease

Author

Kurose Yuko, Wada Jun, Kanzaki Motoko, Teshigawara Sanae, Nakatsuka Atsuko, Murakami Kazutoshi, Inoue Kentaro, Terami Takahiro, Katayama Akihiro, Watanabe Mayu, Higuchi Chigusa, Eguchi Jun, Miyatake Nobuyuki, and Makino Hirofumi

Subjects
Type 2 diabetes, Glomerular filtration, Inflammation, Kidney disease, Nephropathy, Diseases of the genitourinary system. Urology, RC870-923
Abstract

Abstract Background Galectin-9 (Gal-9) induces apoptosis in activated T helper 1 (TH1) cells as a ligand for T cell immunoglobulin mucin-3 (Tim-3). Gal-9 also inhibits the G1 phase cell cycle arrest and hypertrophy in db/db mice, the hallmark of early diabetic nephropathy, by reversing the high glucose-induced up-regulation of cyclin dependent kinase inhibitors such as p27Kip1 and p21Cip1. Methods We investigated the serum levels of Gal-9 in the patients with type 2 diabetes and various stages of chronic kidney disease (CKD) (n=182). Results Serum Gal-9 levels in the patients with type 2 diabetes were 131.9 ± 105.4 pg/ml and Log10Gal-9 levels significantly and positively correlated with age (r=0.227, p=0.002), creatinine (r=0.175, p=0.018), urea nitrogen (r=0.162, p=0.028) and osmotic pressure (r=0.187, p=0.014) and negatively correlated with estimated glomerular filtration rate (eGFR) (r=−0.188, p=0.011). Log10Gal-9 levels increased along with the progression of GFR categories of G1 to G4, and they were statistically significant by Jonckheere-Terpstra test (p=0.012). Log10Gal-9 levels remained similar levels in albuminuria stages of A1 to A3. Conclusion The elevation of serum Gal-9 in the patients with type 2 diabetes is closely linked to GFR and they may be related to the alteration of the immune response and inflammation of the patients with type 2 diabetes and CKD.

Published
2013
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246. The serum vaspin levels are reduced in Japanese chronic hemodialysis patients

Author

Inoue Junko, Wada Jun, Teshigawara Sanae, Hida Kazuyuki, Nakatsuka Atsuko, Takatori Yuji, Kojo Shoichirou, Akagi Shigeru, Nakao Kazushi, Miyatake Nobuyuki, McDonald John F, and Makino Hirofumi

Subjects
Adipokine, End-stage renal disease, Hemodialysis, Diseases of the genitourinary system. Urology, RC870-923
Abstract

Abstract Background Visceral adipose tissue-derived serine proteinase inhibitor (vaspin) is an adipokine identified in genetically obese rats that correlates with insulin resistance and obesity in humans. Recently, we found that 7% of the Japanese population with the minor allele sequence (A) of rs77060950 exhibit higher levels of serum vaspin. We therefore evaluated the serum vaspin levels in Japanese chronic hemodialysis patients. Methods Healthy Japanese control volunteers (control; n = 95, 49.9±6.91 years) and Japanese patients undergoing hemodialysis therapy (HD; n = 138, 51.4±10.5 years) were enrolled in this study, and serum samples were subjected to the human vaspin RIA system. Results The measurement of the serum vaspin levels demonstrated that a fraction of control subjects (n = 5) and HD patients (n = 11) exhibited much higher levels (> 10 ng/ml; VaspinHigh group), while the rest of the population exhibited lower levels (< 3 ng/ml; VaspinLow group). By comparing the patients in the VaspinLow group, the serum vaspin levels were found to be significantly higher in the control subjects (0.87±0.24 ng/ml) than in the HD patients (0.32±0.15 ng/ml) (p Conclusions The creatinine levels are negatively correlated with the serum vaspin levels and were significantly reduced in the Japanese HD patients in the VaspinLow group.

Published
2012
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250. A case of focal segmental glomerulosclerosis in an adult patient with hypogammaglobulinemia superimposed on membranoproliferative glomerulonephritis in childhood

Author

Tsuji Kenji, Uchida Haruhito, Ono Tetsuichirou, Inoue Tatsuyuki, Shinagawa Katsuji, Kitamura Shinji, Maeshima Yohei, Sugiyama Hitoshi, and Makino Hirofumi

Subjects
Hypogammaglobulinemia, Focal segmental glomerulosclerosis, Proteinuria, Diseases of the genitourinary system. Urology, RC870-923
Abstract

Abstract Background Common variable immunodeficiency (CVID) is a disorder characterized by hypogammaglobulinemia without a known predisposing cause. Case presentation We report a 36-year-old man who had suffered membranoproliferative glomerulonephritis (MPGN) in his childhood, later diagnosed with CVID at 35 years of age. He presented at our hospital with signs of proteinuria. A renal biopsy revealed he suffered from focal segmental glomerulosclerosis (FSGS), possibly due to obesity and hypertension, not CVID - associated MPGN. Conclusion This is the first case report of FSGS in a CVID patient. In this case, we have to pay attention not only to the treatment of obesity and hypertension for FSGS but also to the recurrence of immune-complex glomerulonephritis such as MPGN, in case of the restoration of hypogammaglobulinemia.

Published
2012
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