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A Phase 2b Diabetic Kidney Disease Study

CompletedPhase 2

Sponsor: AstraZeneca

Conditions: Diabetic Kidney Disease

Interventions: MEDI3506, Placebo, Dapagliflozin

Countries: United States, Argentina, Canada, Chile, Japan, Peru, South Korea

A Phase 2b Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of MEDI3506 in Subjects with Diabetic Kidney Disease

Eligibility overview

Sex: ALL

Age: 18 Years to 101 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Key Inclusion Criteria

1. Adult men or women ≥ 18 years of age.
2. Diabetic kidney disease DKD defined as:

   1. diagnosis of T2DM
   2. eGFR 25-75 mL/min/1.73 m2
   3. UACR 100-3000 mg albumin/g creatinine
3. BP ≤ 150/100 mmHg
4. Stable dose of ACEi or ARB Key Exclusion Criteria

1\. Serum potassium \> 5.5 mmol/L 2. Significant hepatic disease 3. Hemoglobin A1c \> 10.5 % 4. B-type natriuretic peptide level \> 200 pg/mL 5. History of clinically significant heart disease 6. Anticipated dialysis or renal transplantation within 1 year 7. History of underlying condition that predisposes the subject to infections 8. Significant infection (viral, bacterial, or fungal) 9. Amputation due to peripheral artery disease 10. Subjects with a positive diagnostic nucleic acid test for SARS-CoV-2 11. Pregnancy, breastfeeding or intention to become pregnant during the course of the study, 12. Any other medical condition or clinically relevant abnormal findings in physical examination, laboratory results, or electrocardiogram (ECG) during screening that, in the opinion of the investigator, may compromise the safety of the subject in the study, reduce the subject's ability to participate in the study, or interfere with evaluation of the investigational product

Locations (97)

Birmingham, Alabama, United States
Huntsville, Alabama, United States
Mesa, Arizona, United States
Alhambra, California, United States
Glendale, California, United States
Granada Hills, California, United States
Huntington Park, California, United States
Northridge, California, United States
Sacramento, California, United States
San Diego, California, United States
San Dimas, California, United States
Vacaville, California, United States
Fleming Island, Florida, United States
Hialeah, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Atlanta, Georgia, United States
Honolulu, Hawaii, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Iowa City, Iowa, United States
Manhattan, Kansas, United States
Topeka, Kansas, United States
Wichita, Kansas, United States
Flint, Michigan, United States
Henderson, Nevada, United States
Las Vegas, Nevada, United States
Berlin, New Jersey, United States
Charlotte, North Carolina, United States
Greensboro, North Carolina, United States
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