Clinical Trials List
2024-07-01 - 2027-12-31
Phase III
Recruiting23
ICD-10N05.0
Unspecified nephritic syndrome with minor glomerular abnormality
ICD-10N05.1
Unspecified nephritic syndrome with focal and segmental glomerular lesions
ICD-10N05.6
Unspecified nephritic syndrome with dense deposit disease
ICD-10N05.7
Unspecified nephritic syndrome with diffuse crescentic glomerulonephritis
ICD-10N05.8
Unspecified nephritic syndrome with other morphologic changes
ICD-10N06.0
Isolated proteinuria with minor glomerular abnormality
ICD-10N06.1
Isolated proteinuria with focal and segmental glomerular lesions
ICD-10N06.6
Isolated proteinuria with dense deposit disease
ICD-10N06.7
Isolated proteinuria with diffuse crescentic glomerulonephritis
ICD-10N06.8
Isolated proteinuria with other morphologic lesion
ICD-10N07.0
Hereditary nephropathy, not elsewhere classified with minor glomerular abnormality
ICD-10N07.1
Hereditary nephropathy, not elsewhere classified with focal and segmental glomerular lesions
ICD-10N07.6
Hereditary nephropathy, not elsewhere classified with dense deposit disease
ICD-10N07.7
Hereditary nephropathy, not elsewhere classified with diffuse crescentic glomerulonephritis
ICD-10N07.8
Hereditary nephropathy, not elsewhere classified with other morphologic lesions
ICD-10N14.0
Analgesic nephropathy
ICD-10N14.1
Nephropathy induced by other drugs, medicaments and biological substances
ICD-10N14.2
Nephropathy induced by unspecified drug, medicament or biological substance
ICD-10N14.3
Nephropathy induced by heavy metals
ICD-10N14.4
Toxic nephropathy, not elsewhere classified
ICD-10N15.0
Balkan nephropathy
ICD-10N15.8
Other specified renal tubulo-interstitial diseases
ICD-9583.89
Nephritis and nephropathy, not specified as acute or chronic, with other specified pathological lesion in kidney
Studies of Heart & Kidney Protection with BI 690517 in combination with empagliflozin: A multicenter, international, randomized, double-blind, placebo-controlled clinical trial of the aldosterone synthase inhibitor BI 690517 in combination with empagliflozin in patients with chronic kidney disease
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Sponsor
SSH
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Trial scale
Multi-Regional Multi-Center
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Update
2025/10/31
Investigators and Locations
Co-Principal Investigator
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Co-Principal Investigator
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Co-Principal Investigator
- 周以新 Division of Nephrology
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Co-Principal Investigator
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Co-Principal Investigator
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Co-Principal Investigator
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Co-Principal Investigator
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Co-Principal Investigator
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Co-Principal Investigator
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Co-Principal Investigator
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Co-Principal Investigator
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Co-Principal Investigator
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Co-Principal Investigator
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Co-Principal Investigator
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Co-Principal Investigator
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Co-Principal Investigator
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Co-Principal Investigator
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Co-Principal Investigator
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Condition/Disease
Objectives
Test Drug
‧ BI 690517
Empagliflozin
Active Ingredient
9800008700
BI 690517
6820401000
Dosage Form
Dosage
001
MG
001
Endpoints
Kidney disease progression (defined as kidney failure† or a sustained ≥40% decline in
eGFR from randomization); or
Hospitalization for heart failure; or
Cardiovascular death
Inclution Criteria
laboratory results recorded at least 3 months before and at the time of the Screening
visit, and requires:
(a) CKD-EPIt eGFR ≥20 <45 mL/min/1.73m²; or
(b) CKD-EPI eGFR ≥45 <90 mL/min/1.73m2 with uACR ≥200 mg/g (or protein-to-
creatinine ratio ≥300 mg/g).
Exclusion Criteria
limited to either the Screening or Randomization visit as indicated below):
(i) Blood potassium of >5.2 mmol/Lu at Screening visit;
(ii) Blood ALT or AST >3x ULN at Screening visit;
(iii) Known liver cirrhosis;
(iv) On dialysis, functioning kidney transplant, or scheduled living donor
transplant;
The Estimated Number of Participants
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Taiwan
400 participants
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Global
11000 participants
