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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Incyte Corporation
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01683409
First received: September 7, 2012
Last updated: October 13, 2014
Last verified: October 2014

September 7, 2012
October 13, 2014
August 2012
September 2014   (final data collection date for primary outcome measure)
Change from Baseline in Urinary Albumin/Creatinine Ratio (UACR) at 24 Weeks [ Time Frame: Baseline, 24 Weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01683409 on ClinicalTrials.gov Archive Site
  • Change from Baseline in Creatinine Clearance at 24 Weeks [ Time Frame: Baseline, 24 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L) at 24 Weeks [ Time Frame: Baseline, 24 Weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study to Test Safety and Efficacy of Baricitinib in Participants With Diabetic Kidney Disease
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetic Kidney Disease
  • Drug: baricitinib
    Administered orally
    Other Names:
    • LY3009104
    • INCB28050
  • Drug: Placebo
    Administered orally
  • Experimental: High dose baricitinib (once daily)

    Dose Group 1

    Administered orally, given as three tablets in the morning and one tablet in the evening for 24 weeks. Placebo tablets given to maintain blind.

    Interventions:
    • Drug: baricitinib
    • Drug: Placebo
  • Experimental: Medium dose baricitinib (once daily)

    Dose Group 2

    Administered orally, given as three tablets in the morning and one tablet in the evening for 24 weeks. Placebo tablets given to maintain blind.

    Interventions:
    • Drug: baricitinib
    • Drug: Placebo
  • Experimental: Medium dose baricitinib (twice daily)

    Dose Group 3

    Administered orally, given as three tablets in the morning and one tablet in the evening for 24 weeks. The total daily dose remains the same as Dose Group 2. Placebo tablets given to maintain blind.

    Interventions:
    • Drug: baricitinib
    • Drug: Placebo
  • Experimental: Low dose baricitinib (once daily)

    Dose Group 4

    Administered orally, given as three tablets in the morning and one tablet in the evening for 24 weeks. Placebo tablets given to maintain blind.

    Interventions:
    • Drug: baricitinib
    • Drug: Placebo
  • Placebo Comparator: Placebo
    Placebo administered orally, twice daily, three tablets in the morning and one tablet in the evening for 24 weeks. Placebo tablets given to maintain blind.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
250
November 2014
September 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Japan,   Mexico,   Puerto Rico
 
NCT01683409
14734, I4V-MC-JAGQ
No
Eli Lilly and Company
Eli Lilly and Company
Incyte Corporation
Study Director: 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) Eli Lilly and Company
Eli Lilly and Company
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP