Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
TERMINATED
Clinical Phase
PHASE2
Total Enrollment
417 participants
Study Classification
INTERVENTIONAL
Study Start Date
2010-07-31
Study Completion Date
2014-07-31
Brief Summary
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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.
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Detailed Description
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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).
Conditions
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Diabetic Kidney Disease
Diabetic Nephropathy
Diabetic Glomerulosclerosis
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
TRIPLE
Participants
Caregivers
Investigators
Study Groups
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Placebo
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DRUG
Subcutaneous injection given monthly for 12 months
2 mg LY2382770
Group Type
EXPERIMENTAL
LY2382770
Intervention Type
DRUG
Subcutaneous injection given monthly for 12 months
10 mg LY2382770
Group Type
EXPERIMENTAL
LY2382770
Intervention Type
DRUG
Subcutaneous injection given monthly for 12 months
50 mg LY2382770
Group Type
EXPERIMENTAL
LY2382770
Intervention Type
DRUG
Subcutaneous injection given monthly for 12 months
Interventions
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LY2382770
Subcutaneous injection given monthly for 12 months
Intervention Type
DRUG
Placebo
Subcutaneous injection given monthly for 12 months
Intervention Type
DRUG
Eligibility Criteria
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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.
* 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.
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
* 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
Minimum Eligible Age
25 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Phoenix, Arizona, United States
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Inglewood, California, United States
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Los Angeles, California, United States
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Northridge, California, United States
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Denver, Colorado, United States
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Port Charlotte, Florida, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
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Idaho Falls, Idaho, United States
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Wichita, Kansas, United States
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Kenner, Louisiana, United States
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Rockville, Maryland, United States
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Kansas City, Missouri, United States
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Omaha, Nebraska, United States
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Chapel Hill, North Carolina, United States
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Charlotte, North Carolina, United States
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Durham, North Carolina, United States
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Greenville, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Beachwood, Ohio, United States
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Bend, Oregon, United States
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Providence, Rhode Island, United States
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Orangeburg, South Carolina, United States
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Dallas, Texas, United States
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Lufkin, Texas, United States
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St. George, Utah, United States
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Suffolk, Virginia, United States
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Milwaukee, Wisconsin, United States
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Camperdown, New South Wales, Australia
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Concord, New South Wales, Australia
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Gosford, New South Wales, Australia
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Liverpool, New South Wales, Australia
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Adelaide, South Australia, Australia
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Launceston, Tasmania, Australia
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Box Hill, Victoria, Australia
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Fitzroy, Victoria, Australia
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Heidelberg, Victoria, Australia
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Melbourne, Victoria, Australia
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Parkville, Victoria, Australia
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Reservoir, Victoria, Australia
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Nedlands, Western Australia, Australia
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Český Krumlov, , Czechia
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Děčín, , Czechia
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Jilemnice, , Czechia
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Liberec, , Czechia
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Ostrava, , Czechia
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Prague, , Czechia
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Tábor, , Czechia
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Teplice, , Czechia
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Grenoble, , France
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Lyon, , France
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Nanterre, , France
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Valenciennes, , France
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Vandœuvre-lès-Nancy, , France
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Baja, , Hungary
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Balatonfüred, , Hungary
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Budapest, , Hungary
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Gyöngyös, , Hungary
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Győr, , Hungary
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Kaposvár, , Hungary
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Nagykanizsa, , Hungary
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Szeged, , Hungary
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Szigetvár, , Hungary
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Zalaegerszeg, , Hungary
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Ashkelon, , Israel
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Hadera, , Israel
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Haifa, , Israel
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Holon, , Israel
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Jerusalem, , Israel
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Kfar Saba, , Israel
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Nahariya, , Israel
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Rehovot, , Israel
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Safed, , Israel
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Tel Aviv, , Israel
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Tel Litwinsky, , Israel
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Ẕerifin, , Israel
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Cidra, , Puerto Rico
Site Status
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.
Rio Piedras, , Puerto Rico
Site Status
Countries
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United States
Australia
Czechia
France
Hungary
Israel
Puerto Rico
Other Identifiers
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H9V-MC-GFRF
Identifier Type: OTHER
Identifier Source: secondary_id
10168
Identifier Type: -
Identifier Source: org_study_id
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