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A Study of Dapagliflozin in Chinese Adult Patients With Chronic Kidney Disease
A Study of Dapagliflozin in Chinese Adult Patients With Chronic Kidney Disease
Active Not RecruitingPhase 4
Sponsor: AstraZeneca
Conditions: Chronic Kidney Disease
Interventions: Dapagliflozin
Countries: China
The purpose of this study is to describe the efficacy and safety information with dapagliflozin in Chinese patients with chronic kidney disease.
Eligibility overview
Sex: ALL
Age: 18 Years to 130 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
Eligibility criteria
Inclusion Criteria: * Provision of signed informed consent prior to any study specific procedures * Chinese Female or male aged ≥ 18 years at the time of consent * eGFR ≥ 25 and ≤ 75 mL/min/1.73m2 (CKD-EPI Formula) at visit 1 * Evidence of increased albuminuria 3 months or more before visit 1 and UACR ≥ 200 and ≤ 5000 mg/g 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 anti-neutrophil cytoplasmic antibodies-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 * T1DM * New York Heart Association class IV Congestive Heart Failure at the time of enrolment * MI, unstable angina, stroke or TIA within 12 weeks prior to enrolment * Coronary revascularization (PCI or CABG) or valvular repair/replacement within 12 weeks prior to enrolment * Any condition outside the renal and CV disease area, such as but not limited to malignancy, with a life expectancy of less than 2 years based on investigator´s clinical judgement * Active malignancy requiring treatment at the time of visit 1 (with the exception of successfully treated basal cell or treated squamous cell carcinoma) * Hepatic impairment (AST or ALT \> 3 × ULN; or total bilirubin \> 2 × ULN at time of enrolment). An solated increase in bilirubin in patients with known Gilbert's syndrome is not a reason for exclusion * Known blood-borne diseases * Women of child-bearing potential (ie, those who are not chemically or surgically sterilised or who are not post-menopausal) who are not willing to use a medically accepted method of contraception that is considered reliable in the judgment of the investigator, from the time of signing the informed consent throughout the study and 4 weeks thereafter, OR women who have a positive pregnancy test at enrolment OR women who are breast-feeding * Involvement in the planning and/or conduct of the study (applies to both AstraZeneca personnel and/or site personnel) * Previous enrolled in the present study * Participation in another clinical study with a study intervention during the last month prior to enrolment * Inability of the patient, in the opinion of the investigator, to understand and/or comply with study intervention, procedures and/or follow-up OR any conditions that, in the opinion of the investigator, may render the patient unable to complete the study
Locations (34)
- Beijing, China
- Beijing, China
- Beijing, China
- Beijing, China
- Beijing, China
- Changchun, China
- Dongguan, China
- Foshan, China
- Fuyang, China
- Fuzhou, China
- Ganzhou, China
- Harbin, China
- Hefei, China
- Hengyang, China
- Huaian, China
- Huizhou, China
- Jilin City, China
- Jinan, China
- Jining, China
- Lanzhou, China
- Linyi, China
- Nanchang, China
- Nanjing, China
- Nanning, China
- Ningbo, China
- Shanghai, China
- Shenzhen, China
- Suzhou, China
- Taian, China
- Tianjin, China
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