A Study to Test Safety and Efficacy of Baricitinib in Participants With Diabetic Kidney Disease



Status:Completed
Conditions:Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:18 - Any
Updated:5/3/2014
Start Date:August 2012
End Date:November 2014
Contact:There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Phone:: 1-317-615-4559

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A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Phase 2 Study to Evaluate the Safety and Renal Efficacy of LY3009104 in Patients With Diabetic Kidney Disease

This is a dose ranging study to evaluate the safety and efficacy of baricitinib in the
treatment of participants with mild to moderate diabetic kidney disease.


Inclusion Criteria:

- Participants with Type 2 diabetes treated with at least one antihyperglycemic
medicine for 12 months

- Have diabetic kidney disease and receiving one of two specific medicines used to
treat high blood pressure or diabetic kidney disease for at least 3 months

- Estimated Glomerular Filtration Rate (eGFR) of 25 to 70 milliliter per minute per
1.73 square meter (mL/min/1.73 m^2) (as determined by the Chronic Kidney Disease
Epidemiology Collaboration equation) and a urinary albumin/creatinine ratio (UACR)
>300 milligram per gram (mg/g) and <5000 mg/g

Exclusion Criteria:

- Too high blood pressure when you enter the study

- Some specific medicines used to treat high blood pressure or diabetic kidney disease

- Frequent high blood glucose levels

- Renal transplant or past history of dialysis

- Nonsteroidal anti-inflammatory drugs (NSAIDs)

- Had a special X-ray in the past 30 days which involved also receiving an injection of
dye into the vein

- Major surgery within 8 weeks of study entry or will require major surgery during the
study

- Some types of vaccination

- Shingles or currently have symptoms of a cold sore

- Serious viral, bacterial, fungal, or parasitic infection, or a urinary infection,
Tuberculosis (TB)

- Human immunodeficiency virus (HIV) infection- the virus that causes Acquired
immunodeficiency syndrome (AIDS)

- Have or had some blood disorders, enlarged lymph glands or spleen, or some cancers.

- Serious circulatory, breathing, liver, stomach or bowel problems, neurological or
psychiatric disorders

- Heart attack or heart failure, or a stroke

- Other serious disorders or illnesses

- Electrocardiogram (ECG) heart trace abnormalities

- Alcohol or illegal drug abuse

- Donated more than 500 mL of blood in the last 30 days (no blood donations allowed
during the study)

- Pregnant or breastfeeding
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37
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