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Mar. 26, 2019

Oct. 01, 2023

jRCTs021180043

Estimating the efficacy of the oral alkalizers in patients with chronic kidney disease.

Efficacy of the alkalizers on CKD(CKOALA study)

Jan. 15, 2019

101

ALL of analyzable registration; n 95, median Age 65y.o., Male 62/female 33,DM 43. Withdrawal of informed consent; n 6. Standard group; n 31, median Age 64y.o., Male 21/female 10,DM 14. Bicarbonate group; n 32, median Age 65y.o., Male 21/female 11,DM 14. Uraryt group; n 32, median Age 64y.o., Male 21/female 11,DM 15.

The registration was proceeded under central monitoring by Clinical Research Data Center on Tohoku University hospital. Registrtion number of the original design was 150 people, but registration was very delayed due to the low consent rate. The registration period was set to 5 years, and the final number was 101.

None of severe adverse events.

Primary Endpoint Development of originally-defined significant renal dysfunction or occurrence of any cerebrovascular disease during Short-term study period Occurrence number Standard group n2 Bicarbonate group n0 vs Standard p=0.55 Citrate group n0 vs Standard p=0.55 Secondary Endpoint Development of originally-defined significant renal dysfunction or occurrence of any cerebrovascular disease in Long-term study 1Y 2Y Occurrence at 1Y Standard group n1 Bicarbonate group n0 vs. Standard, p=0.24 Citrate group n0 vs Standard p=0.24 Occurrence at 2Y Standard group n1 Bicarbonate group n0 vs Standard p=1.00. Citrate group n0 vs Standard p=0.24 Evaluation on renal function Serum Creatinine Not significant difference on comparison between 0W and each point 6W 12W 6M 1Y and 2Y within each group Not significant difference on comparison among 3 groups at each point A significant difference on longitudinal comparison among 3 groups p=0.0166 Proteinuria Not significant difference on comparison between 0W and each point 6W 12W 6M 1Y and 2Y in Standard group A significant increasing at 6M compared with 0W in Bicarbonate group 0W mean 0.252g/gCr SE 0.07 6M mean 0.4212g/gCr SE 0.12 p=0.0139 Significant decreasings at 1Y and 2Y compared with 0W in Citrate group 0W mean 0.306g/gCr SE 0.09 1Y mean 0.198g/gCr SE 0.05 2Y mean 0.241g/gCr SE 0.07 0W vs1Y p=0.0061 0W vs2Y p=0.0186 Not significant difference on comparison among 3 groups at each point Not significant difference on longitudinal comparison among 3 groups p=0.2443 Estimated GFR-Cr Not significant difference on comparison between 0W and each point 6W 12W 6M 1Y and 2Y within each group Not significant difference on comparison among 3 groups at each point A significant difference on longitudinal comparison among 3 groups p=0.0042 Evaluation in urinary surrogate marker Urinary albumin excretion Not significant difference on comparison between 0W and each point 6W 12W 6M 1Y and 2Y in Standard group and Citrate group A significant increasing at 12W compared with 0W in Bicarbonate group 0W mean 43.09mg/gCr SE 9.19 12W mean 125.74mg/gCr SE 47.73 p=0.0325 Not significant difference on comparison among 3 groups at each point A significance on longitudinal comparison among 3 groups p=0.4199 Urinary alpha-microglobulin excretion Not significant difference on comparison between 0W and each point 6W 12W 6M 1Y and 2Y within each group Not significant difference on comparison among 3 groups at each point. Not significant difference on longitudinal comparison among 3 groups p=0.1067 Urinary NAG excretion Not significance on comparison between 0W and each point 6W 12W 6M within each group Not significant difference on comparison among 3 groups at each point. Not significant difference on longitudinal comparison among 3 groups p=0.1665 Urinary NGAL excretion Not significance on comparison between 0W and each point 6W 12W 6M within each group Not significant difference on comparison among 3 groups at each point. Not significant difference on longitudinal comparison among 3 groups p=0.8242 Urinary KIM-1 excretion Not significance on comparison between 0W and each point 6W 12W 6M within each group Not significant difference on comparison among 3 groups at each point Not significant difference on longitudinal comparison among 3 groups p=0.4075 Urinary L-FABP excretion Not significance on comparison between 0W and each point 6W 12W 6M within each group. Not significant difference on comparison among 3 groups at each point.Not significant difference on longitudinal comparison among 3 groups p=0.1894 Urinary 8-Isoprostan excretion Not significance on comparison between 0W and each point 6W 12W 6M within each group Not significant difference on comparison among 3 groups at each point.Not significant difference on longitudinal comparison among 3 groups p=0.7697 Urinary 8-OHdG excretion Not significance on comparison between 0W and each point 6W 12W 6M within each group Not significant difference on comparison among 3 groups at each point.Not significant difference on longitudinal comparison among 3 groups p=0.2948 Urinary Type IV-Collagen excretion Not significance on comparison between 0W and each point 6W 12W 6M within each group. Significant differences on comparison among 3 groups at 6W and 1Y p=0.0493, p=0.0421 A significant difference on longitudinal comparison among 3 groups p=0.046 Urinary TGF-beta excretion Not significance on comparison between 0W and each point 6W 12W 6M within each group Not significant difference on comparison among 3 groups at each point Not significant difference on longitudinal comparison among 3 groups p=0.1746 Urinary Angiotensinogen excretion Not significance on comparison between 0W and each point 6W 12W 6M within each group Not significant difference on comparison among 3 groups at each point. Not significant difference on longitudinal comparison among 3 groups p=0.2076 Urinary MCP-1 excretion Not significance on comparison between 0W and each point 6W 12W 6M within each group. Not significant difference on comparison among 3 groups at each point Not significant difference on longitudinal comparison among 3 groups p=0.8575 Urinary IL-6 excretion Not significance on comparison between 0W and each point 6W 12W 6M within each group. Not significant difference on comparison among 3 groups at each point. Not significant difference on longitudinal comparison among 3 groups p=0.89 Early-morning urine pH A significant decreasing at 1Y compared with 0W in Standard group 0W mean 5.581 SE 0.07 6M mean 0.4212g/gCr SE 0.12 p=0.0139 Not significance difference on comparison within Bicarbonate group Significant increasing at 6M and 2Y compared with 0W in Citrate group 0W 5.8825 SE 0.07525 6M 6.2355 SE 0.1045 2Y 6.3367 SE 0.1865 0W vs. 6M p=0.0102 0W vs 2Y p= 0.0385 . Significant differences on comparison among 3 groups at 6M and 1Y p=0.0078, p=0.019. Not significance difference on longitudinal comparison among 3 groups p=0.402 Urinary Lactate excretion A significant decreasing at 6M compared with 0W in Standard group 0W 0.123 SE 0.0171 6M 0.1107 SE 0.0151 p=0.0221 A significant increasing at 6M compared with 0W in Citrate group 0W 0.1027 SE 0.01064 6M 0.1566 SE 0.02092 p=0.0016 Not significant difference on comparison among 3 groups at each point. Not significant difference on longitudinal comparison among 3 groups p=0.1744 Performance state by SF-8 at 6M Not significant differences on comparison between Standard group and Bicarbonate group or Citrate group Protocol paper BMC Nephrol. 2020 Apr 22;21-1 144 Doi 10.1186/s12882-020-01807-8

There are no changes on primary endpoint. For secondary endpoint, treatment by sodium/potassium citrate could increase morning-urine pH and might improve serum creatinine and eGFR-Cr. The limitation of the study is low number of the registration.

Oct. 01, 2023

No

No Plan

https://jrct.niph.go.jp/latest-detail/jRCTs021180043

Abe Michiaki

Tohoku University Hospital

1-1 Seiryo-machi, Aoba-ku, Sendai,Miyagi 980-8574 ,Japan

+81-22-717-7587

michiabe@med.tohoku.ac.jp

Abe Michiaki

Tohoku University Hospital

1-1 Seiryo-machi, Aoba-ku, Sendai,Miyagi 980-8574 ,Japan

+81-22-717-7587

michiabe@med.tohoku.ac.jp

Complete

Mar. 01, 2013

April. 02, 2013
150

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

1) A patient with chronic kidney disease and age >= 20, < 81 years.
2) Signed and dated informed consent document indicating that patient has been informed of all pertinent aspects of this trial prior to enrollment.

1) Serious heart disease or liver disease.
2) Patients with alkaline urine.
3) Patients who are judged unfit to enroll in this trial by the investigator.

20age old over
80age old under

Both

Chronic kidney disease

Compare among three groups for six months; the standard therapy group whose patients have not administrated any oral alkalizers or alkalinizing therapies based on the CKD guideline, the first alkalizer group and the second alka
lizer group.

D007676

Serum creatinine level, eGFR, protein urea,cardiovascular disease.

Urinary surrogate marker.

Nippon Chemiphar
Not applicable
Tohoku Certified Review Board of Tohoku University
2-1-1 Katahira, Aoba-ku, Sendai, Miyagi, 980-8577 Japan, Miyagi

+81-22-718-0461

office@nrs.hosp.tohoku.ac.jp
Approval

UMIN000010059
UMIN Clinical Trials Registry (UMIN-CTR)

none

History of Changes

No Publication date
7 Oct. 01, 2023 (this page) Changes
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1 Mar. 26, 2019 Detail