Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Symphony Evolution, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Type 1 or Type 2 diabetes mellitus with albuminuria, observed within 3 months of screening
Prior to randomization, subject has a glomerular filtration rate (GFR) \>/= 40 mL/min
Prior to randomization, the subject has albuminuria defined as ACR \>/= 500 mg/g
Stable seated blood pressure at the screening visit and prior to randomization
Subject has been on a stable dose and schedule of an angiotension converting enzyme (ACE) inhibitor and/or an angiotension receptor blocker (ARB) for at least 3 months before first dose of study drug
If on antidiabetic medication, subject has been on a stable dose and schedule for at least 3 months prior to first dose of study drug
Sexually active subjects must use an accepted method of contraception during the course of the study and for 3 months after
Signed informed consent
You may not be if
Subject has participated in an investigational study and received an investigational drug within 30 days of the first dose of XL784
Hemoglobin A1c (HbA1c) value of \>10% at screening
Subject has had either organ transplantation or is currently on immunosuppressive therapy
Non-steroidal anti-inflammatory drugs (NSAIDs) within 5 days of urine screening assessments
Current diagnosis of one or more of the following conditions: 1) infection requiring parenteral antibiotics, 2) urinary tract infection, 3) hepatic dysfunction or disease, 4) symptomatic congestive heart failure, 5) unstable angina pectoris, 5) serious cardiac arrhythmia
Clinically evident diabetic gastroparesis or motility disturbance
Proteinuria not due to diabetic nephropathy
Diltiazem or verapamil
Ongoing condition where treatment with NSAIDs is anticipated (aspirin \</= 325 mg/day is allowed)
Recent history of drug or alcohol abuse
Pregnant or breastfeeding female subjects
Known HIV and/or receiving anti-retroviral therapy
Known allergy or hypersensitivity to any component of XL784 formulation
Clareo Health | Study of XL784 in Patients With Albuminuria Due to Diabetic Nephropathy
