NCT01683409

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2012

Geographic Reach
4 countries

45 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 7, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 11, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

July 2, 2017

Completed
Last Updated

September 30, 2019

Status Verified

September 1, 2019

Enrollment Period

2.1 years

First QC Date

September 7, 2012

Results QC Date

March 10, 2017

Last Update Submit

September 10, 2019

Conditions

Diabetic Kidney Disease

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Urinary Albumin/Creatinine Ratio (UACR) at 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.

    Baseline, Week 24

Secondary Outcomes (4)

  • Change From Baseline in Urinary Monocyte Chemotactic Protein 1 (MCP-1)/Creatinine Ratio

    Baseline, Week 24

  • Change From Baseline in Creatinine Clearance at Week 24

    Baseline, Week 24

  • Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) at Week 24

    Baseline, Week 24

  • Pharmacokinetics (PK): Area Under the Concentration-Time Curve at Steady State (AUC,ss)

    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)

Study Arms (5)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Baricitinib 0.75 mg/0.5 mg QD

EXPERIMENTAL

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: BaricitinibDrug: Placebo

Baricitinib 0.75 mg/0.5 mg BID

EXPERIMENTAL

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: BaricitinibDrug: Placebo

Baricitinib 1.5 mg/1 mg

EXPERIMENTAL

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: BaricitinibDrug: Placebo

Baricitinib 4 mg/2.75 mg

EXPERIMENTAL

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: BaricitinibDrug: Placebo

Interventions

BaricitinibDRUG

Administered orally

Also known as: LY3009104, INCB28050
Baricitinib 0.75 mg/0.5 mg BIDBaricitinib 0.75 mg/0.5 mg QDBaricitinib 1.5 mg/1 mgBaricitinib 4 mg/2.75 mg
PlaceboDRUG

Administered orally

Baricitinib 0.75 mg/0.5 mg BIDBaricitinib 0.75 mg/0.5 mg QDBaricitinib 1.5 mg/1 mgBaricitinib 4 mg/2.75 mgPlacebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (45)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Lancaster, California, 93534, United States

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

San Diego, California, 92103, United States

Location

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Torrance, California, 90502, United States

Location

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Lakewood, Colorado, 80227, United States

Location

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Fort Lauderdale, Florida, 33316, United States

Location

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Jacksonville, Florida, 32258, United States

Location

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Miami, Florida, 33173, United States

Location

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Tampa, Florida, 33614, United States

Location

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Augusta, Georgia, 30909, United States

Location

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Honolulu, Hawaii, 96814, United States

Location

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Meridian, Idaho, 83642, United States

Location

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Gurnee, Illinois, 60031, United States

Location

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Peoria, Illinois, 60603, United States

Location

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Evansville, Indiana, 47713, United States

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Topeka, Kansas, 66606, United States

Location

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Rockville, Maryland, 20852, United States

Location

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Ann Arbor, Michigan, 48109, United States

Location

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Detroit, Michigan, 48236, United States

Location

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Pontiac, Michigan, 48341, United States

Location

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Springfield, Missouri, 65807, United States

Location

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Billings, Montana, 59101, United States

Location

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Nashua, New Hampshire, 03063, United States

Location

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Albany, New York, 12209, United States

Location

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New York, New York, 10021, United States

Location

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Rosedale, New York, 11422, United States

Location

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Winston-Salem, North Carolina, 27103, United States

Location

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Bethlehem, Pennsylvania, 18017, United States

Location

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Philadelphia, Pennsylvania, 19102, United States

Location

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Sumter, South Carolina, 29150, United States

Location

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Chattanooga, Tennessee, 37408, United States

Location

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Houston, Texas, 77030, United States

Location

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San Antonio, Texas, 78229, United States

Location

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Seattle, Washington, 98104, United States

Location

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Spokane, Washington, 99204, United States

Location

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Wenatchee, Washington, 98801, United States

Location

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Fukuoka, 830-0011, Japan

Location

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Hokkaido, 004-0053, Japan

Location

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Ibaraki, 305-0812, Japan

Location

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Ibaraki, 311-0113, Japan

Location

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Osaka, 530-0001, Japan

Location

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Tokyo, 103-0027, Japan

Location

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Mexico City, 03300, Mexico

Location

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Mérida, 97070, Mexico

Location

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Ponce, 00716, Puerto Rico

Location

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Rio Piedras, 00936, Puerto Rico

Location

MeSH Terms

Conditions

Diabetic Nephropathies

Interventions

baricitinib

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

Study Officials

  • 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

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2012

First Posted

September 11, 2012

Study Start

August 1, 2012

Primary Completion

September 1, 2014

Study Completion

November 1, 2014

Last Updated

September 30, 2019

Results First Posted

July 2, 2017

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will share

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
More information

Locations

JP(6)ME(2)PR(2)US(35)