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Completed

NCT Number: NCT01683409

A Study to Test Safety and Efficacy of Baricitinib in Participants 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.

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Key information

Conditions

Diabetic Kidney Disease Diabetes Complications Diabetes Mellitus Diabetic Nephropathies Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary 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., Fukuoka, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Baricitinib

Drug

Administered orally

Other names: LY3009104, INCB28050

Placebo

Drug

Administered orally

Primary outcomes

  1. 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 outcomes

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

    Time frame: Baseline, Week 24

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Collaborators

  • Incyte Corporation

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Sep 11, 2012
Registry last updated
Sep 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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