This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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
Results First Received: March 10, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Investigator;   Primary Purpose: Treatment
Condition: Diabetic Kidney Disease
Interventions: Drug: Baricitinib
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study included a 24-week treatment period and a 4- to 8-week washout period where study drug was discontinued. Time to loss-of-treatment benefit (defined as a failure to maintain a 30% decrease in UACR from baseline) was evaluated at Week 28. Participants who maintained treatment benefit were followed for an additional 4 weeks.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants in each baricitinib dose group were classified by their baseline estimated glomerular filtration rate (eGFR) into higher (50 to 70 milliliter [mL]/minute [min]/1.73 meters squared [m²]) and lower (25 to <50 mL/min/1.73 m²) eGFR strata. Participants in the lower strata had their dose adjusted to a lower dose.

Reporting Groups
  Description
Placebo Placebo administered orally (PO) once a day (QD).
Baricitinib 0.75 mg/0.5 mg QD Baricitinib 0.75 mg or 0.5 mg administered PO QD.
Baricitinib 0.75 mg/0.5 mg BID Baricitinib 0.75 mg or 0.5 mg administered PO twice a day (BID).
Baricitinib 1.5 mg/1 mg Baricitinib 1.5 mg or 1 mg administered PO QD.
Baricitinib 4 mg/2.75 mg Baricitinib 4 milligram (mg) or 2.75 mg administered PO QD.

Participant Flow for 3 periods

Period 1:   Treatment Period (Weeks 1-24)
    Placebo   Baricitinib 0.75 mg/0.5 mg QD   Baricitinib 0.75 mg/0.5 mg BID   Baricitinib 1.5 mg/1 mg   Baricitinib 4 mg/2.75 mg
STARTED   27   25   27   26   25 
Received at Least One Dose of Study Drug   27   25   26   26   25 
COMPLETED   27   21   26   24   23 
NOT COMPLETED   0   4   1   2   2 
Inappropriately Enrolled                0                0                1                0                0 
Adverse Event                0                3                0                1                1 
Lost to Follow-up                0                1                0                0                0 
Withdrawal by Subject                0                0                0                1                1 

Period 2:   Washout Period 1 (Weeks 25-28)
    Placebo   Baricitinib 0.75 mg/0.5 mg QD   Baricitinib 0.75 mg/0.5 mg BID   Baricitinib 1.5 mg/1 mg   Baricitinib 4 mg/2.75 mg
STARTED   27   21   26   24   23 
COMPLETED   24   17   25   22   20 
NOT COMPLETED   3   4   1   2   3 
Lost to Follow-up                0                0                1                0                0 
Protocol Violation                1                0                0                1                0 
Withdrawal by Subject                1                0                0                0                1 
Physician Decision                1                0                0                0                0 
Adverse Event                0                4                0                1                2 

Period 3:   Washout Period 2 (Weeks 29-32)
    Placebo   Baricitinib 0.75 mg/0.5 mg QD   Baricitinib 0.75 mg/0.5 mg BID   Baricitinib 1.5 mg/1 mg   Baricitinib 4 mg/2.75 mg
STARTED   6 [1]   6 [2]   8 [3]   6 [4]   12 [5] 
COMPLETED   6   6   7   6   9 
NOT COMPLETED   0   0   1   0   3 
Adverse Event                0                0                0                0                3 
Physician Decision                0                0                1                0                0 
[1] Study was completed at Week 28 for 18 participants.
[2] Study was completed at Week 28 for 11 participants.
[3] Study was completed at Week 28 for 17 participants.
[4] Study was completed at Week 28 for 16 participants.
[5] Study was completed at Week 28 for 8 participants.



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants that received at least one dose of study drug.

Reporting Groups
  Description
Placebo Placebo administered PO QD.
Baricitinib 0.75/0.5 mg QD Baricitinib 0.75 mg or 0.5 mg administered PO QD.
Baricitinib 0.75 mg/0.5 mg BID Baricitinib 0.75 mg or 0.5 mg administered PO BID.
Baricitinib 1.5 mg/1 mg QD Baricitinib 1.5 mg or 1 mg administered PO QD.
Baricitinib 4 mg/2.75 mg Baricitinib 4 mg or 2.75 administered PO QD.
Total Total of all reporting groups

Baseline Measures
   Placebo   Baricitinib 0.75/0.5 mg QD   Baricitinib 0.75 mg/0.5 mg BID   Baricitinib 1.5 mg/1 mg QD   Baricitinib 4 mg/2.75 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 27   25   26   26   25   129 
Age 
[Units: Years]
Mean (Standard Deviation)
 64  (9.0)   61  (10.0)   64  (8.3)   61  (10.4)   63  (7.8)   63  (9.1) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
           
Female      7  25.9%      8  32.0%      5  19.2%      5  19.2%      10  40.0%      35  27.1% 
Male      20  74.1%      17  68.0%      21  80.8%      21  80.8%      15  60.0%      94  72.9% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
           
Hispanic or Latino      4  14.8%      4  16.0%      6  23.1%      7  26.9%      4  16.0%      25  19.4% 
Not Hispanic or Latino      23  85.2%      21  84.0%      20  76.9%      19  73.1%      21  84.0%      104  80.6% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
           
American Indian or Alaska Native      2   7.4%      2   8.0%      2   7.7%      2   7.7%      1   4.0%      9   7.0% 
Asian      14  51.9%      12  48.0%      12  46.2%      11  42.3%      11  44.0%      60  46.5% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0%      1   4.0%      1   0.8% 
Black or African American      2   7.4%      7  28.0%      3  11.5%      0   0.0%      3  12.0%      15  11.6% 
White      8  29.6%      4  16.0%      9  34.6%      13  50.0%      9  36.0%      43  33.3% 
More than one race      1   3.7%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      1   0.8% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
           
Puerto Rico   0   1   0   0   0   1 
United States   14   13   14   14   13   68 
Japan   11   10   10   10   11   52 
Mexico   2   1   2   2   1   8 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Urinary Albumin/Creatinine Ratio (UACR) at Week 24   [ Time Frame: Baseline, Week 24 ]

2.  Secondary:   Change From Baseline in Urinary Monocyte Chemotactic Protein 1 (MCP-1)/Creatinine Ratio   [ Time Frame: Baseline, Week 24 ]

3.  Secondary:   Change From Baseline in Creatinine Clearance at Week 24   [ Time Frame: Baseline, Week 24 ]

4.  Secondary:   Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) at Week 24   [ Time Frame: Baseline, Week 24 ]

5.  Secondary:   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) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979



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