臨床研究等提出・公開システム

Date of registration	April. 26, 2021
Last modified on	Sept. 03, 2022
Trial ID	jRCT2031210055

Scientific Title	Randomised, double-blind (within dose groups), placebo-controlled and parallel group trial to investigate the effects of different doses of oral BI 685509 given over 20 weeks on UACR reduction in patients with diabetic kidney disease
Public Title	A study to test the effect of different doses of BI 685509 on kidney function in people with diabetic kidney disease

Contact for Scientific Queries	Name	Saito Isao
	Affiliation	Boehringer Ingelheim
	Address	2-1-1, Osaki, Shinagawa-ku, Tokyo
	Telephone	+81-3-6417-2770
	E-mail	ctinfo@boehringer-ingelheim.com
Contact for Public Queries	Name	Takasu Yuji
	Affiliation	Boehringer Ingelheim
	Address	2-1-1, Osaki, Shinagawa-ku, Tokyo
	Telephone	+81-3-6417-2770
	E-mail	ctinfo@boehringer-ingelheim.com

Recruitment status	Not Recruiting

Anticipated date of first enrollment		May. 15, 2021
Actual date of first enrollment		June. 16, 2021
Target sample size		240
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Male or female patients of legal adult age (according to local legislation) at time of consent. eGFR of 20 and more amd less than 90 mL/min/1.73 m2. UACR of 200 and more and less than 3,500 mg/g. Stable treatment with either ACEi or ARB (not both). Patients with stable type 1 or type 2 diabetes mellitus.
	Exclusion Criteria	Non-diabetic chronic kidney disease. planned start of chronic renal replacement therapy during the trial or end stage renal disease before start of trial treatment.
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Diabetic Kidney Disease
Intervention(s)		Other: Placebo Drug: BI 685509
Primary Outcome(s)		Change from baseline in log transformed UACR measured in 10-hour urine after 20 weeks of trial treatment.

Primary Sponsor	Nippon Boehringer Ingelheim Co., Ltd.

Name of Certified Review Board	IRB of Tokyo-Eki Center-building Clinic
Address	3-3-14 Nihonbashi Chuo-ku, Tokyo
Telephone	+81-3-6262-2811
E-Mail	info_tecc-irb@tec-c.jp
Approval Status	Approval
Date of approval	April. 09, 2021

Plan to share IPD	Yes
Plan description	Researcheres can refer to https://trials.boehringer-ingelheim.com/ to request access to raw data from the clinical trial

Secondary ID(s)	NCT04750577
Issuing Authority	National Institutes of Health

Countries of Recruitment（Except Japan）	Argentina/Australia/Canada/China/Denmark/Malaysia/Mexico/Netherlands/New Zealand/Poland/Portugal/Spain/Unitred Kingdom/United States

History of Changes

No	Publication date
3	Sept. 03, 2022	(this page)	Changes
2	Dec. 25, 2021	Detail	Changes
1	April. 26, 2021	Detail

List of change history