A Study in Participants With Diabetic Kidney Disease



Status:Terminated
Conditions:Diabetic Neuropathy, Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Endocrinology, Nephrology / Urology
Healthy:No
Age Range:25 - Any
Updated:12/15/2017
Start Date:July 2010
End Date:July 2014

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A Randomized, Double-Masked, Placebo-Controlled, Multicenter, Phase 2 Study to Evaluate the Safety and Renal Efficacy of LY2382770 in Patients With Diabetic Kidney Disease Due to Type 1 or Type 2 Diabetes

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.

The primary objective is to determine if LY2382770, administered monthly for 1 year, is more
effective than placebo at slowing the progression of diabetic kidney disease in participants
treated with an angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin II receptor
blocker (ARB).

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
We found this trial at
29
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Charlotte, North Carolina 28207
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Greenville, North Carolina 27834
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