A Study in Participants With Diabetic Kidney Disease

Lilly

Status and phase: Terminated; Phase 2

Conditions: Diabetic Nephropathy; Diabetic Glomerulosclerosis; Diabetic Kidney Disease

Treatments: Drug: Placebo; Drug: LY2382770

Study type: Interventional

Funder types: Industry

Identifiers

NCT01113801

H9V-MC-GFRF (Other Identifier)

10168 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 417 patients

Sex: All

Ages: 25+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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417 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

2 mg LY2382770

Experimental group

Treatment:

Drug: LY2382770

10 mg LY2382770

Experimental group

Treatment:

Drug: LY2382770

50 mg LY2382770

Experimental group

Treatment:

Drug: LY2382770