TY - JOUR
T1 - Reno-protective effects of oral alkalizing agents in chronic kidney disease with aciduria
T2 - Protocol for a randomized cohort study
AU - Abe, Michiaki
AU - Akaishi, Tetsuya
AU - Shoji, Mutsumi
AU - Yamaguchi, Takuhiro
AU - Miki, Takashi
AU - Satoh, Fumitoshi
AU - Takayama, Shin
AU - Yamasaki, Satomi
AU - Kawaguchi, Kazuhiko
AU - Sato, Hiroshi
AU - Ishii, Tadashi
AU - Ito, Sadayoshi
AU - Nakai, Toshiki
AU - Nishioka, Koichiro
AU - Hashimoto, Satoshi
AU - Kiyomoto, Hideyasu
AU - Nakayama, Keisuke
AU - Kudo, Masataka
AU - Morimoto, Ryo
AU - Nakamichi, Takashi
AU - Ogawa, Susumu
AU - Miyazaki, Mariko
AU - Ishizawa, Kota
AU - Numata, Takehiro
N1 - Publisher Copyright:
© 2020 The Author(s).
PY - 2020/4/22
Y1 - 2020/4/22
N2 - Background: Aciduria caused by urinary excretion of acidic metabolic wastes produced in daily life is known to be augmented in patients with chronic kidney disease (CKD). To evaluate the reno-protective effect of oral alkalizing agents for the improvement of metabolic acidosis and neutralization of intratubular pH in the patients with mild stages of CKD. Also, to identify reno-protective surrogate markers in the serum and urine that can closely associate the effect of urine alkalization. Methods: In this single-centered, open-labeled, randomized cohort study, patients with CKD stages G2, G3a and G3b, who visited and were treated at Tohoku University Hospital during the enrollment period were registered. We administered sodium bicarbonate or sodium-potassium citrate as the oral alkalinizing agents. A total of 150 patients with CKD will be randomly allocated into the following three groups: sodium bicarbonate, sodium-potassium citrate and standard therapy group without any alkalinizing agents. The data of performance status, venous blood test, spot urine test, venous blood-gas test, electrocardiogram, renal arterial ultrasonography and chest X-ray will be collected at 0, 6, 12 and 24 weeks (short-term study) from starting the interventions. These data will be also collected at 1 and 2 years (long-term study). The samples of plasma and serum and early-morning urine at every visit will be acquired for the analysis of renal function and surrogate uremic biomarkers. The recruitment for this cohort study terminated in March, 2018, and the follow-up period for all the enrolled subjects will be terminated in December, 2020. The primary endpoint will be the development of originally-defined significant renal dysfunction or the occurrence of any cerebrovascular disease in the short-term study. The secondary endpoint will be the same endpoints as in the long-term study, or the patients with significant changes in the suggested the surrogate biomarkers. Discussion: The findings of this study will address the importance of taking oral alkalizing agents in the patients with early stages of CKD, furthermore they could address any new surrogate biomarkers that can be useful from early stage CKD. Trial registration: Registered Report Identifier: UMIN000010059 and jRCT021180043. The trial registration number; 150. Date of registration; 2013/02/26.
AB - Background: Aciduria caused by urinary excretion of acidic metabolic wastes produced in daily life is known to be augmented in patients with chronic kidney disease (CKD). To evaluate the reno-protective effect of oral alkalizing agents for the improvement of metabolic acidosis and neutralization of intratubular pH in the patients with mild stages of CKD. Also, to identify reno-protective surrogate markers in the serum and urine that can closely associate the effect of urine alkalization. Methods: In this single-centered, open-labeled, randomized cohort study, patients with CKD stages G2, G3a and G3b, who visited and were treated at Tohoku University Hospital during the enrollment period were registered. We administered sodium bicarbonate or sodium-potassium citrate as the oral alkalinizing agents. A total of 150 patients with CKD will be randomly allocated into the following three groups: sodium bicarbonate, sodium-potassium citrate and standard therapy group without any alkalinizing agents. The data of performance status, venous blood test, spot urine test, venous blood-gas test, electrocardiogram, renal arterial ultrasonography and chest X-ray will be collected at 0, 6, 12 and 24 weeks (short-term study) from starting the interventions. These data will be also collected at 1 and 2 years (long-term study). The samples of plasma and serum and early-morning urine at every visit will be acquired for the analysis of renal function and surrogate uremic biomarkers. The recruitment for this cohort study terminated in March, 2018, and the follow-up period for all the enrolled subjects will be terminated in December, 2020. The primary endpoint will be the development of originally-defined significant renal dysfunction or the occurrence of any cerebrovascular disease in the short-term study. The secondary endpoint will be the same endpoints as in the long-term study, or the patients with significant changes in the suggested the surrogate biomarkers. Discussion: The findings of this study will address the importance of taking oral alkalizing agents in the patients with early stages of CKD, furthermore they could address any new surrogate biomarkers that can be useful from early stage CKD. Trial registration: Registered Report Identifier: UMIN000010059 and jRCT021180043. The trial registration number; 150. Date of registration; 2013/02/26.
KW - Bicarbonate
KW - Chronic kidney disease
KW - Citrate
KW - Oral alkalizing agents
KW - Single-centered and randomized cohort study
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U2 - 10.1186/s12882-020-01807-8
DO - 10.1186/s12882-020-01807-8
M3 - Article
C2 - 32321450
AN - SCOPUS:85083948004
VL - 21
JO - BMC Nephrology
JF - BMC Nephrology
SN - 1471-2369
IS - 1
M1 - 144
ER -