臨床研究等提出・公開システム

Date of registration	May. 16, 2018
Last modified on	Nov. 26, 2020
Trial ID	jRCT2080223905

Scientific Title	A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients With Chronic Kidney Disease
Public Title	Dapa-CKD

Completion Date or Terminated date	June. 12, 2020
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD	No
Plan description	-
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	AstraZeneca KK
	Address	-
	Phone Number	-
	E-mail Address	RD-clinical-information-Japan@astrazeneca.com

Contact for Public Queries	Name
	Contact Name for Public Queries	AstraZeneca KK
	Address	-
	Phone Number	-
	E-mail Address	RD-clinical-information-Japan@astrazeneca.com

Recruitment Status	completed

Date of First Enrolment		Mar. 20, 2018
Target Sample Size		240
Study Type		Interventional
Study Design	Study Design	Randomized, Parallel Assignment
Study Design	Objective	treatment purpose
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	- Provision of signed informed consent prior to any study specific procedures - Female or male aged 18 years or more at the time of consent - eGFR 25 or more and 75 mL/min/1.73 m2 (CKD-EPI Formula) or less at visit 1 - Evidence of increased albuminuria 3 months or more before visit 1 and UACR 200 or more and 5000 mg/g or less at visit 1 - Stable, and for the patient maximum tolerated labelled daily dose, treatment with ACE-I or ARB for at least 4 weeks before visit 1, if not medically contraindicated
	Exclusion Criteria	- Autosomal dominant or autosomal recessive polycystic kidney disease, lupus nephritis or ANCA-associated vasculitis - Receiving cytotoxic therapy, immunosuppressive therapy or other immunotherapy for primary or secondary renal disease within 6 months prior to enrolment - History of organ transplantation - Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor - Type 1 diabetes mellitus - New York Heart Association (NYHA) class IV Congestive Heart Failure at the time of enrolment - MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
	Minimum Age	18age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Chronic Kidney Disease
Intervention(s)		investigational material(s) Generic name etc : Dapagliflozin INN of investigational material : dapagliflozin propylene glycolate hydrate Therapeutic category code : 396 Antidiabetic agents Dosage and Administration for Investigational material : 10 mg or 5 mg tablets given once daily, per oral use control material(s) Generic name etc : Placebo INN of investigational material : - Therapeutic category code : --- Other Dosage and Administration for Investigational material : Placebo matching dapagliflozin 10 mg or 5 mg
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		efficacy -
Secondary Outcome		safety efficacy exploratory -

Primary Sponsor	AstraZeneca KK
Secondary Sponsor	-

Name of Funding Organization	-
Name of Research Funding	-

Name of IRB	Institutional Review Board of Asahi Life Foundation
Address of IRB	2-2-6, Nihonbashibakuro-cho, Chuo-ku, Tokyo
Phone Number of IRB	-
E-mail Address of IRB	-
Status of IRB Review	approved
Date of Approval by IRB	Feb. 13, 2018

Secondary ID No.	NCT03036150
Name of Other Registries	ClinicalTrials.gov

Secondary ID No.	JapicCTI-183962
Name of Other Registries

Countries / Regions of Recruitment	Japan/Asia except Japan/North America/South America/Europe

History of Changes

No	Publication date
5	Nov. 26, 2020	(this page)	Changes
4	Aug. 06, 2019	Detail	Changes
3	Dec. 17, 2018	Detail	Changes
2	May. 16, 2018	Detail	Changes
1	May. 16, 2018	Detail

List of change history