A Study to Assess the Renoprotective Effects of the SGLT2 Inhibitor Dapagliflozin in Non-Diabetic Patients With Proteinuria: a Randomized Double Blind 6-Weeks Cross-Over Trial - DIAMOND

niversity Medical Center Groningen0 sites53 target enrollmentJuly 27, 2017

Overview

No summary available.

Registry

who.int

Start Date

July 27, 2017

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•\- Age \=18 and \=75 years
•\- Urinary protein excretion \> 500 mg/g and \= 3500 mg/g in a 24hour 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) 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
•Are the trial subjects under 18? no
•Number of subjects for this age range:

•\- 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.
•\- 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:
•oHistory of active inflammatory bowel disease within the last six months;
•oMajor gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection;