臨床研究等提出・公開システム

Japanese

Date of registration	Jan. 11, 2024
Last modified on	Jan. 11, 2024
Trial ID	jRCT2031230557

Scientific Title	A Phase III, Randomised, Multicentre, Double-blind Study to Evaluate the Efficacy, Safety, and Tolerability of Zibotentan/Dapagliflozin Compared to Dapagliflozin Alone in Participants with Chronic Kidney Disease and High Proteinuria
Public Title	A Phase III Study to Investigate Efficacy, Safety, and Tolerability of Zibotentan/Dapagliflozin Compared to Dapagliflozin in Participants with Chronic Kidney Disease and High Proteinuria (ZENITH High Proteinuria)

Contact for Scientific Queries	Name	Ageishi Yuji
	Affiliation	Astrazeneka K.K
	Address	3-1, Ofuka-cho, Kita-ku, Osaka-shi
	Telephone	+81-6-4802-3533
	E-mail	RD-clinical-information-Japan@astrazeneca.com
Contact for Public Queries	Name	Ageishi Yuji
	Affiliation	Astrazeneka K.K
	Address	3-1, Ofuka-cho, Kita-ku, Osaka-shi
	Telephone	+81-6-4802-3533
	E-mail	RD-clinical-information-Japan@astrazeneca.com

Recruitment status	Pending

Anticipated date of first enrollment		Feb. 15, 2024
Actual date of first enrollment
Target sample size		200
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	active control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1. Participant must be 18 years or more of age at the time of signing the informed consent. 2. eGFR 20 or more and below 90 mL/min/1.73m2 by central laboratory at screening Visit 1, using CKD-EPI 2021 formula and UACR above 700 mg/g (above 79 mg/mmol) or UPCR above 1000 mg/g (above 113 mg/mmoL). 3. All female participants must have a negative serum pregnancy test result at screening. 4. Receiving RAASi therapy (ACEi or ARB), and for the patient maximum tolerated labelled daily dose, that has been stable for at least 4 weeks.
	Exclusion Criteria	1. Participants with New York Heart Association classification class III or class IV HF. 2. Participants hospitalised for HF during the last 6 months prior to screening. 3. Participants with type 1 diabetes mellitus. 4. Systolic blood pressure above 160 mmHg. 5. Systolic blood pressure below 90 mmHg. 6. Participants hospitalised for heart disease or cardiac procedures or for COVID-19 during the last 3 months prior to screening. 7. History of solid organ transplantation or bone marrow transplant. 8. Malignancy within the past 5 years. 9. Significant liver disease. 10. Participants on renal replacement therapy or previous kidney transplant. 11. Participants on treatment with strong or moderate CYP3A4 inducer. 12. Participants on systemic immunosuppression therapy other than stable maintenance therapy for at least 3 months prior to Visit 1. 13. Participants treated or expecting to be treated with tolvaptan, any other ERAs, or budesonide.
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Chronic Kidney Disease and High Proteinuria
Intervention(s)		Zibotentan/dapagliflozin 0.25mg/10mg Fixed Dose Combination Once daily Zibotentan/dapagliflozin 0.75mg/10mg Fixed Dose Combination Once daily Dapagliflozin 10mg Once daily
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Change in eGFR from baseline to Month 24.
Secondary Outcome(s)

Primary Sponsor	Astrazeneca K.K

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Tokyo-Eki Center-building Clinic institutional review board
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	Dec. 15, 2023

Plan to share IPD	No
Plan description

Secondary ID(s)	NCT06087835
Issuing Authority	ClinicalTrials.gov

Countries of Recruitment（Except Japan）	Argentina/Australia/Austria/Brazil/Bulgaria/Canada/China/Denmark/France/Germany/India/Israel/Italy/Malaysia/Mexico/Netherlands/Norway/Philippines/Poland/Slovakia/South Africa/South Korea/Spain/Sweden/Taiwan/Thailand/Turkey/United Kingdom/ United States of America/Vietnam