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 |
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.
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
We found this trial at
37
sites
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