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

NCT ID: NCT01683409

Last Updated: 2019-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2014-11-30

Brief 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.

Conditions

Diabetic Kidney Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Administered orally, given as three placebo tablets in the morning and one placebo tablet in the evening for 24 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Administered orally

Baricitinib 0.75 mg/0.5 mg QD

Administered orally, 0.75 mg given as one 0.75 mg tablets and two placebo tablets in the morning and one placebo tablet in the evening for 24 weeks or 0.5 mg given as one 0.5 mg tablet and two placebo tablets in the morning and one placebo tablet in the evening for 24 weeks. Placebo tablets given to maintain blind.

Group Type: EXPERIMENTAL

Baricitinib

Intervention Type: DRUG

Administered orally

Placebo

Intervention Type: DRUG

Administered orally

Baricitinib 0.75 mg/0.5 mg BID

Administered orally, 0.75 mg given as one 0.75 tablet and 2 placebo in the morning and one 0.75 mg tablet in the evening for 24 weeks or 0.5 mg given as one 0.5 mg tablet and two placebo tablets in the morning and one 0.5 mg tablet in the evening. Placebo tablets given to maintain blind.

Group Type: EXPERIMENTAL

Baricitinib

Intervention Type: DRUG

Administered orally

Placebo

Intervention Type: DRUG

Administered orally

Baricitinib 1.5 mg/1 mg

Administered orally, 1.5 mg given as two 0.75 mg tablets and 1 placebo tablet in the morning and one placebo tablet in the evening for 24 weeks or 1 mg tablet and two placebo tablets in the morning and one placebo tablet in the evening for 24 weeks. Placebo tablets given to maintain blind.

Group Type: EXPERIMENTAL

Baricitinib

Intervention Type: DRUG

Administered orally

Placebo

Intervention Type: DRUG

Administered orally

Baricitinib 4 mg/2.75 mg

Administered orally, 4 mg given as one tablet and 2 placebo tablets in the morning and one placebo tablet in the evening for 24 weeks or 2.75 mg given as two 1 mg tablets and one 0.75 mg tablet in the morning and one placebo tablet in the evening for 24 weeks. Placebo tablets given to maintain blind.

Group Type: EXPERIMENTAL

Baricitinib

Intervention Type: DRUG

Administered orally

Placebo

Intervention Type: DRUG

Administered orally

Interventions

Baricitinib

Administered orally

Intervention Type: DRUG

Placebo

Administered orally

Intervention Type: DRUG

Other Intervention Names

LY3009104; INCB28050

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Incyte Corporation

INDUSTRY

Sponsor Role: collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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Lancaster, California, United States

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San Diego, California, United States

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Torrance, California, United States

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Lakewood, Colorado, United States

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Fort Lauderdale, Florida, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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Tampa, Florida, United States

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Augusta, Georgia, United States

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Honolulu, Hawaii, United States

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Meridian, Idaho, United States

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Gurnee, Illinois, United States

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Peoria, Illinois, United States

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Evansville, Indiana, United States

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Topeka, Kansas, United States

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Rockville, Maryland, United States

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Ann Arbor, Michigan, United States

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Detroit, Michigan, United States

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Pontiac, Michigan, United States

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Springfield, Missouri, United States

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Billings, Montana, United States

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Nashua, New Hampshire, United States

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Albany, New York, United States

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New York, New York, United States

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Rosedale, New York, United States

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Winston-Salem, North Carolina, United States

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Bethlehem, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Sumter, South Carolina, United States

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Chattanooga, Tennessee, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Seattle, Washington, United States

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Spokane, Washington, United States

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Wenatchee, Washington, United States

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Fukuoka, , Japan

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Hokkaido, , Japan

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Ibaraki, , Japan

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Ibaraki, , Japan

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Osaka, , Japan

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Tokyo, , Japan

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Mexico City, , Mexico

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Mérida, , Mexico

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Ponce, , Puerto Rico

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Rio Piedras, , Puerto Rico

Countries

United States; Japan; Mexico; Puerto Rico

Other Identifiers

I4V-MC-JAGQ

Identifier Type: OTHER

Identifier Source: secondary_id

14734

Identifier Type: -

Identifier Source: org_study_id