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

• Status: Completed
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Collaborator: Incyte Corporation

Criteria

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 m²) (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