Phase
Condition
Kidney Disease
Focal Segmental Glomerulosclerosis
Nephropathy
Treatment
Dapagliflozin
Clinical Study ID
Ages 18-130 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 withACE-I or ARB for at least 4 weeks before visit 1, if not medically contraindicated
Exclusion
Exclusion Criteria:
Autosomal dominant or autosomal recessive polycystic kidney disease, lupus nephritisor anti-neutrophil cytoplasmic antibodies-associated vasculitis
Receiving cytotoxic therapy, immunosuppressive therapy or other immunotherapy forprimary 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 orprevious intolerance of an SGLT2 inhibitor
T1DM
New York Heart Association class IV Congestive Heart Failure at the time ofenrolment
MI, unstable angina, stroke or TIA within 12 weeks prior to enrolment
Coronary revascularization (PCI or CABG) or valvular repair/replacement within 12weeks prior to enrolment
Any condition outside the renal and CV disease area, such as but not limited tomalignancy, with a life expectancy of less than 2 years based on investigator´sclinical judgement
Active malignancy requiring treatment at the time of visit 1 (with the exception ofsuccessfully treated basal cell or treated squamous cell carcinoma)
Hepatic impairment (AST or ALT > 3 × ULN; or total bilirubin > 2 × ULN at time ofenrolment). An solated increase in bilirubin in patients with known Gilbert'ssyndrome is not a reason for exclusion
Known blood-borne diseases
Women of child-bearing potential (ie, those who are not chemically or surgicallysterilised or who are not post-menopausal) who are not willing to use a medicallyaccepted method of contraception that is considered reliable in the judgment of theinvestigator, 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 ORwomen who are breast-feeding
Involvement in the planning and/or conduct of the study (applies to both AstraZenecapersonnel and/or site personnel)
Previous enrolled in the present study
Participation in another clinical study with a study intervention during the lastmonth prior to enrolment
Inability of the patient, in the opinion of the investigator, to understand and/orcomply 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 thestudy
Study Design
Study Description
Connect with a study center
Research Site
Beijing, 100044
ChinaSite Not Available
Research Site
Beijing 1816670, 100191
ChinaSite Not Available
Research Site
Changchun, 130021
ChinaSite Not Available
Research Site
Changchun 2038180, 130021
ChinaSite Not Available
Research Site
Changsha, 410011
ChinaSite Not Available
Research Site
Changsha 1815577, 410011
ChinaSite Not Available
Research Site
Dongguan, 523059
ChinaSite Not Available
Research Site
Dongguan 1812545, 523059
ChinaSite Not Available
Research Site
Foshan, 528308
ChinaSite Not Available
Research Site
Foshan 1811103, 528308
ChinaSite Not Available
Research Site
Fuyang, 236600
ChinaSite Not Available
Research Site
Fuyang 1810845, 236012
ChinaSite Not Available
Research Site
Fuzhou, 350001
ChinaSite Not Available
Research Site
Fuzhou 1810821, 350001
ChinaSite Not Available
Research Site
Ganzhou, 341099
ChinaSite Not Available
Research Site
Ganzhou 1810638, 341099
ChinaSite Not Available
Research Site
Harbin, 150000
ChinaSite Not Available
Research Site
Harbin 2037013, 150000
ChinaSite Not Available
Research Site
Hefei, 230601
ChinaSite Not Available
Research Site
Hefei 1808722, 230601
ChinaSite Not Available
Research Site
Hengyang, 421001
ChinaSite Not Available
Research Site
Hengyang 1808370, 421001
ChinaSite Not Available
Research Site
Huaian, 223399
ChinaSite Not Available
Research Site
Huizhou, 516001
ChinaSite Not Available
Research Site
Huizhou 1806776, 516001
ChinaSite Not Available
Research Site
Jilin, 132011
ChinaSite Not Available
Research Site
Jilin 2036502, 132011
ChinaSite Not Available
Research Site
Jinan, 250014
ChinaSite Not Available
Research Site
Jinan 1805753, 250014
ChinaSite Not Available
Research Site
Jining, 272029
ChinaSite Not Available
Research Site
Jining 1805518, 272029
ChinaSite Not Available
Research Site
Lanzhou, 730000
ChinaSite Not Available
Research Site
Lanzhou 1804430, 730000
ChinaSite Not Available
Research Site
Linyi, 276199
ChinaSite Not Available
Research Site
Linyi 1803318, 276199
ChinaSite Not Available
Research Site
Nanchang, 330006
ChinaSite Not Available
Research Site
Nanchang 1800163, 330006
ChinaSite Not Available
Research Site
Nanjing, 210029
ChinaSite Not Available
Research Site
Nanjing 1799962, 210029
ChinaSite Not Available
Research Site
Nanning, 530021
ChinaSite Not Available
Research Site
Nanning 1799869, 530021
ChinaSite Not Available
Research Site
Ningbo, 315010
ChinaSite Not Available
Research Site
Ningbo 1799397, 315010
ChinaSite Not Available
Research Site
Shanghai, 200090
ChinaSite Not Available
Research Site
Shanghai 1796236, 200090
ChinaSite Not Available
Research Site
Shenzhen, 518036
ChinaSite Not Available
Research Site
Shenzhen 1795565, 518036
ChinaSite Not Available
Research Site
Suzhou, 215004
ChinaSite Not Available
Research Site
Suzhou 1886760, 215004
ChinaSite Not Available
Research Site
Taian, 271099
ChinaSite Not Available
Research Site
Tianjin, 300121
ChinaSite Not Available
Research Site
Tianjin 1792947, 300121
ChinaSite Not Available
Research Site
Wuhu, 241000
ChinaSite Not Available
Research Site
Wuhu 1791236, 241000
ChinaSite Not Available
Research Site
Wuxi, 214023
ChinaSite Not Available
Research Site
Wuxi 1790923, 214023
ChinaSite Not Available
Research Site
Xi'an 1790630, 710000
ChinaSite Not Available
Research Site
Xiamen, 361004
ChinaSite Not Available
Research Site
Xiamen 1790645, 361004
ChinaSite Not Available
Research Site
Xian, 710000
ChinaSite Not Available
Research Site
Zhumadian, 463000
ChinaSite Not Available
Research Site
Zhumadian 1783873, 463000
ChinaSite Not Available

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