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Effects of Dapagliflozin in Non-diabetic Patients With Proteinuria
Effects of Dapagliflozin in Non-diabetic Patients With Proteinuria
CompletedPhase 2
Sponsor: Hiddo Lambers Heerspink
Conditions: Chronic Kidney Diseases, Proteinuria
Interventions: Dapagliflozin 10mg
Countries: Canada, Malaysia, Netherlands
This study tests the hypothesis that dapagliflozin lowers proteinuria in patients with non-diabetic chronic kidney disease.
Eligibility overview
Sex: ALL
Age: 18 Years to 75 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
Eligibility criteria
Inclusion Criteria: * Age ≥18 and ≤75 years * Urinary protein excretion \> 500 mg/g and ≤ 3500 mg/g in a 24-hr urine collection eGFR ≥ 25 mL/min/1.73m2 * On a stable dose of an ACEi or ARB for at least 4 weeks prior to randomization * Willing to sign informed consent * Women of Child-Bearing Potential (WOCBP): * WOCBP must be using an acceptable method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the last dose of study drug in such a manner that the risk of pregnancy is minimized. * WOCBP must have a negative serum or urine pregnancy test result (minimum sensitivity 25 IU/L or equivalent units of HCG) within 0 to 72 hours before the first dose of study drug. * Women must not be breast-feeding. WOCBP comprises women who have experienced menarche and who have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or who are not post-menopausal. Exclusion Criteria: * Diagnosis of type 1 or type 2 diabetes mellitus * Urinary protein excretion \> 3500 mg/day * Peripheral Vascular Disease * Autosomal dominant polycystic kidney disease or autosomal recessive polycystic kidney disease, lupus nephritis, or ANCA-associated vasculitis * Indication for immunosuppressants as per the treating physician's judgment. * Receiving cytotoxic therapy, immunosuppressive therapy, or other immunotherapy for primary or secondary renal disease within 6 months prior to enrolment. * Active malignancy aside from treated squamous cell or basal cell carcinoma of the skin. * Use of co-interventional treatments (outlined in section 4.2 of the protocol) within 6 weeks of screening will not be allowed. * Any medication, surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of medications including, but not limited to any of the following: * History of active inflammatory bowel disease within the last six months; * Major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection; * Gastro-intestinal ulcers and/or gastrointestinal or rectal bleeding within last six months; * Pancreatic injury or pancreatitis within the last six months; * Evidence of hepatic disease as determined by any one of the following: ALT or AST values exceeding 3x ULN at the screening visit, a history of hepatic encephalopathy, a history of esophageal varices, or a history of portocaval shunt; * Evidence of urinary obstruction of difficulty in voiding at screening * History of severe hypersensitivity or contraindications to dapagliflozin * Subject who, in the assessment of the investigator, may be at risk for dehydration or volume depletion that may affect the interpretation of efficacy or safety data * Participation in any clinical investigation within 3 months prior to initial dosing. * Donation or loss of 400 ml or more of blood within 8 weeks prior to initial dosing. * History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by the laboratory assays conducted during the screening. * History of noncompliance to medical regimens or unwillingness to comply with the study protocol. * Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study. * Pregnancy or breastfeeding * WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and up to 4 weeks after the last dose of study drug.
Locations (7)
- Vancouver, British Columbia, Canada
- Toronto, Ontario, Canada
- Kuala Lumpur, Malaysia
- Kuala Lumpur, Malaysia
- Almelo, Netherlands
- Amsterdam, Netherlands
- Groningen, Netherlands