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A Study to Test Safety and Efficacy of Baricitinib in Participants With Diabetic Kidney Disease | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Study to Test Safety and Efficacy of Baricitinib in Participants With Diabetic Kidney Disease

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

NCT01683409•Eli Lilly and Company

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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)
+9 more criteria

Locations (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, United States

San Diego, California, United States

Torrance, California, United States

Lakewood, Colorado, United States

Fort Lauderdale, Florida, United States

Jacksonville, Florida, United States

Miami, Florida, United States

Tampa, Florida, United States

Augusta, Georgia, United States

Honolulu, Hawaii, United States

Key Dates

Start Date

August 1, 2012

Primary Completion Date

September 1, 2014

Completion Date

November 1, 2014

Last Updated

September 30, 2019

Enrollment

130

ACTUAL participants

Conditions

Diabetic Kidney Disease

Interventions

Baricitinib

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 30, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Test Safety and Efficacy of Baricitinib in Participants With Diabetic Kidney Disease

Inclusion Criteria

Exclusion Criteria

Study to Assess the Effects of Angiopoietin-like Protein 3 (ANGPTL3) Inhibition in Adult Participants With Diabetic Kidney Disease

The Evaluation of the Drug R3R01 for the Excretion of Protein in the Urine in Patients With Diabetic Kidney Disease.

Trial of Semaglutide for Diabetic Kidney Disease in Type 1 Diabetes

Mechanism of SGLT2 Inhibition in the Kidney

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