Effects of Dapagliflozin in Non-diabetic Patients With Proteinuria (NCT03190694) | Clinical Trial Compass
CompletedPhase 2
Effects of Dapagliflozin in Non-diabetic Patients With Proteinuria
Canada, Malaysia, Netherlands53 participantsStarted 2017-11-12
Plain-language summary
This study tests the hypothesis that dapagliflozin lowers proteinuria in patients with non-diabetic chronic kidney disease.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Change in 24-hr Proteinuria With Dapagliflozin for Six Weeks Relative to Placebo in Patients With Non-diabetic Kidney Disease and Proteinuria 500 mg/Day on Stable Angiotensin-converting Enzyme Inhibitor or Angiotensin II Receptor Blocker Treatment.