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

This study has been completed.
Sponsor:
Collaborator:
Incyte Corporation
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01683409
First received: September 7, 2012
Last updated: June 2, 2017
Last verified: June 2017
  Purpose
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.

Condition Intervention Phase
Diabetic Kidney Disease Drug: Baricitinib Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Phase 2 Study to Evaluate the Safety and Renal Efficacy of Baricitinib in Patients With Diabetic Kidney Disease

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Change From Baseline in Urinary Albumin/Creatinine Ratio (UACR) at Week 24 [ Time Frame: Baseline, Week 24 ]
    UACR is a potential marker of chronic kidney disease, calculated as a ratio of Urinary Albumin and Urinary Creatinine. The least squares mean (LS mean) are from mixed model repeated measures (MMRM) analyses which include treatment, baseline estimated Glomerular Filtration Rate (eGFR) group (higher: 50 to 70 mL/min/1.73m² and lower: 25 to <50 mL/min/1.73m²), visit, treatment-by-visit interaction, baseline UACR, and baseline UACR-by-visit interaction.


Secondary Outcome Measures:
  • Change From Baseline in Urinary Monocyte Chemotactic Protein 1 (MCP-1)/Creatinine Ratio [ Time Frame: Baseline, Week 24 ]
  • Change From Baseline in Creatinine Clearance at Week 24 [ Time Frame: Baseline, Week 24 ]
    Creatinine clearance is the amount of creatinine cleared from kidney within 24 hours. The LS mean was from MMRM analyses which included treatment, baseline eGRF group, visit, treatment-by-visit interaction, baseline Creatinine Clearance, and baseline Creatinine Clearance-by-visit interaction.

  • Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) at Week 24 [ Time Frame: Baseline, Week 24 ]
    EQ-5D-5L is a 2-part measurement. The first part is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1. A higher score indicates better health state. The second part is assessed using a visual analog scale (VAS) that ranged from 0 to 100mm, where 0 is the worst health you can imagine and 100 is the best health you can imagine. The LS means are analyzed using an analysis of covariance (ANCOVA) model with treatment, baseline eGFR group, and baseline VAS score or baseline health state index score as covariates.

  • Pharmacokinetics (PK): Area Under the Concentration-Time Curve at Steady State (AUC,ss) [ Time Frame: Weeks 2 and 4 (1-2 hours postdose), 8 (3-6 hours postdose), 12 (in fasted state), 16 and 20 (6-9 hours postdose), 24 (in fasted state) ]
    Evaluable pharmacokinetic concentrations from the 2-week, 4-week, 8-week, 12-week, 16-week, 20-week and 24-week time points were combined and utilized in a population approach to determine the population mean estimate and standard deviation at steady-state.


Enrollment: 130
Study Start Date: August 2012
Study Completion Date: November 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Administered orally, given as three placebo tablets in the morning and one placebo tablet in the evening for 24 weeks.
Drug: Placebo
Administered orally
Experimental: 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.
Drug: Baricitinib
Administered orally
Other Names:
  • LY3009104
  • INCB28050
Drug: Placebo
Administered orally
Experimental: 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.
Drug: Baricitinib
Administered orally
Other Names:
  • LY3009104
  • INCB28050
Drug: Placebo
Administered orally
Experimental: 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.
Drug: Baricitinib
Administered orally
Other Names:
  • LY3009104
  • INCB28050
Drug: Placebo
Administered orally
Experimental: 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.
Drug: Baricitinib
Administered orally
Other Names:
  • LY3009104
  • INCB28050
Drug: Placebo
Administered orally

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01683409

  Show 45 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Incyte Corporation
Investigators
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
  More Information

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01683409     History of Changes
Other Study ID Numbers: 14734
I4V-MC-JAGQ ( Other Identifier: Eli Lilly and Company )
Study First Received: September 7, 2012
Results First Received: March 10, 2017
Last Updated: June 2, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.


Additional relevant MeSH terms:
Kidney Diseases
Diabetic Nephropathies
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 21, 2017