Diabetic Kidney DiseasePhase 2NCT01683409
A Study to Test Safety and Efficacy of Baricitinib in Participants With Diabetic Kidney Disease
A Phase 2 study testing Baricitinib in people with Diabetic Kidney Disease, run by Eli Lilly and Company at 45 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Kidney Disease
- What is being tested?
- Baricitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 45 sitesin 4 countries
- Study dates
- Aug 2012to Nov 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
45 sites in 4 countries.
45 sites in 4 countries
United States35 sites
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.
Albany, New York, 12209
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Ann Arbor, Michigan, 48109
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Augusta, Georgia, 30909
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Bethlehem, Pennsylvania, 18017
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Billings, Montana, 59101
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Chattanooga, Tennessee, 37408
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Detroit, Michigan, 48236
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Evansville, Indiana, 47713
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Fort Lauderdale, Florida, 33316
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Gurnee, Illinois, 60031
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Honolulu, Hawaii, 96814
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Houston, Texas, 77030
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Jacksonville, Florida, 32258
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Lakewood, Colorado, 80227
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Lancaster, California, 93534
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Meridian, Idaho, 83642
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Miami, Florida, 33173
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Nashua, New Hampshire, 03063
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New York, New York, 10021
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Peoria, Illinois, 60603
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Philadelphia, Pennsylvania, 19102
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Pontiac, Michigan, 48341
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Rockville, Maryland, 20852
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Rosedale, New York, 11422
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San Antonio, Texas, 78229
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San Diego, California, 92103
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Seattle, Washington, 98104
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Spokane, Washington, 99204
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Springfield, Missouri, 65807
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Sumter, South Carolina, 29150
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Tampa, Florida, 33614
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Topeka, Kansas, 66606
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Torrance, California, 90502
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Wenatchee, Washington, 98801
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Winston-Salem, North Carolina, 27103
Japan6 sites
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Fukuoka, 830-0011
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Hokkaido, 004-0053
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Ibaraki, 305-0812
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Ibaraki, 311-0113
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Osaka, 530-0001
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Tokyo, 103-0027
Mexico2 sites
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Mérida, 97070
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Mexico City, 03300
Puerto Rico2 sites
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Ponce, 00716
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Rio Piedras, 00936
About this study
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
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
- Being tested
- Baricitinib, Placebo
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BaricitinibDrug
Also called LY3009104, INCB28050
Administered orally
PlaceboDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Administered orally, given as three placebo tablets in the morning and one placebo tablet in the evening for 24 weeks. Receives: 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. Receives: Drug: Baricitinib; Drug: 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. Receives: Drug: Baricitinib; Drug: 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. Receives: Drug: Baricitinib; Drug: 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. Receives: Drug: Baricitinib; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 24
Secondary outcomes (4)
Change From Baseline in Urinary Monocyte Chemotactic Protein 1 (MCP-1)/Creatinine Ratio
Measured: Baseline, Week 24
Change From Baseline in Creatinine Clearance at 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.
Measured: Baseline, Week 24
Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) at 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.
Measured: Baseline, Week 24
Pharmacokinetics (PK): Area Under the Concentration-Time Curve at Steady State (AUC,ss)
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2012 (estimated)
- Study startAug 2012
- Primary completionSep 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Incyte Corporation
- Responsible party
- Sponsor
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01683409
- Sponsor's protocol ID
- 14734
- Other IDs
- I4V-MC-JAGQ
- Status last verified
- Sep 2019
- First submitted
- 7 Sep 2012
- Last updated
- 30 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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.
Publications
Hu S, Lee K, He JC, Fan Y. Current Landscape and Emerging Therapeutic Targets in Diabetic Kidney Disease. Clin J Am Soc Nephrol. 2026 Mar 10. doi: 10.2215/CJN.0000001053. Online ahead of print.
PubMed 41805697
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01683409
- Acronym / sponsor ID
- 14734
- Conditions
- Diabetic Kidney Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Incyte Corporation
- Study start
- Aug 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 11 Sep 2012 (estimated)
- Results
- Posted 2 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboAdministered orally, given as three placebo tablets in the morning and one placebo tablet in the evening for 24 weeks. |
| Baricitinib 0.75 mg/0.5 mg QD | Experimental | Drug: Baricitinib, Drug: PlaceboAdministered 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. |
| Baricitinib 0.75 mg/0.5 mg BID | Experimental | Drug: Baricitinib, Drug: PlaceboAdministered 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. |
| Baricitinib 1.5 mg/1 mg | Experimental | Drug: Baricitinib, Drug: PlaceboAdministered 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. |
| Baricitinib 4 mg/2.75 mg | Experimental | Drug: Baricitinib, Drug: PlaceboAdministered 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (19 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BaricitinibAlso: LY3009104, INCB28050Administered orally | Drug | Baricitinib 0.75 mg/0.5 mg BID, Baricitinib 0.75 mg/0.5 mg QD, Baricitinib 1.5 mg/1 mg, Baricitinib 4 mg/2.75 mg |
| PlaceboAdministered orally | Drug | Baricitinib 0.75 mg/0.5 mg BID, Baricitinib 0.75 mg/0.5 mg QD, Baricitinib 1.5 mg/1 mg, Baricitinib 4 mg/2.75 mg, Placebo |
Primary outcome
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.
4 secondary outcomes
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
Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) at Week 24
Time frame: Baseline, Week 24
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41805697Hu S, Lee K, He JC, Fan Y. Current Landscape and Emerging Therapeutic Targets in Diabetic Kidney Disease. Clin J Am Soc Nephrol. 2026 Mar 10. doi: 10.2215/CJN.0000001053. Online ahead of print.
- Individual participant dataSharing planned: Yes. 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.
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Diabetic Nephropathy Type 2, Type 2 Diabetes Mellitus
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Family Investigation of Nephropathy and Diabetes (F.I.N.D.)
Diabetic Nephropathy, Diabetes Mellitus
Active, not recruitingPhase 4
Pentoxifylline in Diabetic Kidney Disease
Diabetic Kidney Disease
Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
Diabetic Kidney Disease (DKD), Type 2 Diabetes
Not yet recruitingObservational study
Relationship Between Insulin Dose and Complications in Type 1 Diabetes
Diabetes Mellitus, Type 1 Diabetes, Cardiovascular Diseases (CVD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
45 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Baricitinib in people with Diabetic Kidney Disease, run by Eli Lilly and Company at 45 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in United States, Japan, Mexico, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Urinary Albumin/Creatinine Ratio (UACR) at Week 24 (time frame: Baseline, Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01683409, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2019.