臨床研究等提出・公開システム

Date of registration	Oct. 07, 2022
Last modified on	Oct. 07, 2022
Trial ID	jRCT1031220369

Scientific Title	Prospective obsevational study in IgA nephropathy patients treated with dapahliflozin
Public Title	Dapagliflozin treatment in IgA nephropathy patients

Contact for Scientific Queries	Name	Tomohito Gohda
	Affiliation	Juntendo University Hospital
	Address	2-1-1 Hongo, Bunkyo-ku
	Telephone	+81-3-3813-3111
	E-mail	goda@juntendo.ac.jp
Contact for Public Queries	Name	Tomohito Gohda
	Affiliation	Juntendo University Hospital
	Address	2-1-1 Hongo, Bunkyo-ku
	Telephone	+81-3-3813-3111
	E-mail	goda@juntendo.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Nov. 26, 2021
Target sample size		150
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	(1) Diagnosis of IgA nephropathy by renal biopsy (2) IgA nephropathy patients treated with dapagliflozin (3) 20 years of age and older at the time of consent acquisition (4) Receiving maximum tolerated dose of RAS inhibitors (excluding not tolerable case due to AE) (5) After completion of predonine treatment (6) eGFR more than 25 mL/min/1.73 m2 (7) Postive proteinuria (8) Patients who have been fully informed about their participation in this study, and who have given their free and voluntary written consent based on a thorough understanding of the subject's own
	Exclusion Criteria	(1) Patients who are taking or may start steroids or other immunosuppressive drugs during the study period (2) Patients who cannot walk on their own and need assistance or a wheelchair to get to the hospital (3) Patients under treatment for malignant tumors (4) BMI less than 18 (5) Other exclusion criteria include patients deemed inappropriate as research subjects by the principal investigator A research subject is eligible if he/she meets all of the selection criteria and none of the exclusion criteria listed above
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		IgA nephropathy
Primary Outcome(s)		Change in proteinuria and eGFR from baseline

Primary Sponsor	AstraZeneca

Secondary Sponsor

Name of Certified Review Board	Juntendo clinical research review board
Address	2-1-1 Hongo, Bunkyo-ku, Tokyo
Telephone	+81-3-5802-1584
E-Mail	crbjun@juntendo.ac.jp
Approval Status	Approval
Date of approval	Nov. 19, 2021

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none