Phase 2
N=130
A Study to Test Safety and Efficacy of Baricitinib in Participants With Diabetic Kidney Disease
Diabetic Kidney Disease
Bottom Line
View on ClinicalTrials.gov: NCT01683409 ↗Enrolled (actual)
130
Serious AEs
4.5%
Results posted
Jul 2017
Primary outcome: Primary: Change From Baseline in Urinary Albumin/Creatinine Ratio (UACR) at Week 24 — 1.12; 0.87; 0.85; 0.91 milligram/gram (mg/g)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Baricitinib (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Urinary Albumin/Creatinine Ratio (UACR) at Week 24 |
1.12; 0.87; 0.85; 0.91; 0.66 | — |
| SECONDARY Change From Baseline in Urinary Monocyte Chemotactic Protein 1 (MCP-1)/Creatinine Ratio |
— | — |
| SECONDARY Change From Baseline in Creatinine Clearance at Week 24 |
0.93; 1.09; 0.86; 0.86; 0.080 | — |
| SECONDARY Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) at Week 24 |
0.00; -0.03; -0.01; -0.04; 0.00; 0.00 | — |
| SECONDARY Pharmacokinetics (PK): Area Under the Concentration-Time Curve at Steady State (AUC,ss) |
198; 286; 388; 1250 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01683409). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.