Phase 2a Safety study of MEDI3506 in Subjects with Diabetic Kidney Disease (FRONTIER-1)
Eligibility
Inclusion Criteria
DKD defined as the diagnosis of T2DM and eGFR 30-75 mL/min and Micro- or macro-albuminuria of 100-3000 mg albumin/g creatinine
Stable BP
on stable dose of ACEi or ARB as tolerated
Exclusion Criteria
Diagnosis of CKD other than diabetic renal disease
abnormal liver function tests
HbA1c > 10.5%
BNP level > 200 pg/mL
NYHA Class 3 or 4 heart failure and/or history of recent hospitalization for heart failure
history of unstable arrhythmias
Inflammatory Bowl Disease
anticipated dialysis or renal transplantation;
prior malignancy
history of herpes zoster, hepatitis B, hepatitis C, or HIV
history or evidence of active tuberculosis (TB) infection
Ongoing use of any biologic drug and/or small molecule targeting the immune system