A Study in Participants With Diabetic Kidney Disease

• Status: Terminated
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if LY2382770 is safe and effective at protecting kidney function in participants with kidney disease due to diabetes.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company

Criteria

Main Inclusion Criteria:

• Participants with chronic kidney disease presumed due to diabetes Type 1 or Type 2

• Participants with certain levels of kidney function - serum creatinine (SCr) 1.3 to 3.3 mg/dl (115 to 291 micromol/L) inclusive for women and 1.5 to 3.5 mg/dl (132 to 309 micromol/L) inclusive for men, or an estimated glomerular filtration rate (eGFR) 20 to 60 mL/min/1.73 m²

• Participants with protein in the urine - 24-hour urine protein/creatinine ratio (PCR) greater than or equal to 800 mg/g (greater than or equal to 91 mg/mmol).

• Participants must be on a stable and acceptable dose of an ACE (angiotensin-converting enzyme) inhibitor or an ARB (angiotensin II receptor blocker), or not able to tolerate these medications.

Main Exclusion Criteria:

• Female participants who can become pregnant, are pregnant or breastfeeding

• Participants who have any of the following medical conditions (the site research staff will discuss these criteria and determine a participant's ability to participate)

• Chronic inflammatory or autoimmune diseases

• Chronic Kidney Disease from causes other than diabetes

• An organ transplant

• Too high a blood pressure

• Viral Hepatitis B or C liver infection, liver cirrhosis, or significant liver disease

• Recent gastrointestinal bleeding

• Acute kidney injury within the 3 months before screening

• Major surgery within 3 months before screening or plan to have it during the study period

• HIV infection- the virus that causes AIDS

• Heart disease that is not considered stable

• Cancer that is too recent or other condition which poses too high a risk for developing cancer

• Required to take drugs that change the immune system