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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

NCT06610526

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
  • + 4 more on CT.gov