A Study in Patients With Diabetic Kidney Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01113801
First received: April 28, 2010
Last updated: September 29, 2014
Last verified: August 2014

April 28, 2010
September 29, 2014
July 2010
May 2014   (final data collection date for primary outcome measure)
Change in Serum Creatinine from baseline to 12 month endpoint [ Time Frame: Baseline, 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01113801 on ClinicalTrials.gov Archive Site
  • Change in Urine Protein/Creatinine Ratio from baseline to 12 month endpoint [ Time Frame: Baseline, 12 months ] [ Designated as safety issue: No ]
  • Population PK [ Time Frame: Baseline through 12 months ] [ Designated as safety issue: No ]
  • Serum creatinine slope of change from baseline through 12 months [ Time Frame: Baseline through 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study in Patients With Diabetic Kidney Disease
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 patients 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 patients treated with an angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin II receptor blocker (ARB).

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Diabetic Kidney Disease
  • Diabetic Nephropathy
  • Diabetic Glomerulosclerosis
  • Drug: LY2382770
    Subcutaneous injection given monthly for 12 months
  • Drug: Placebo
    Subcutaneous injection given monthly for 12 months
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: 2 mg LY2382770
    Intervention: Drug: LY2382770
  • Experimental: 10 mg LY2382770
    Intervention: Drug: LY2382770
  • Experimental: 50 mg LY2382770
    Intervention: Drug: LY2382770
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
July 2014
May 2014   (final data collection date for primary outcome measure)

Main Inclusion Criteria:

  • Patients with chronic kidney disease presumed due to diabetes Type 1 or Type 2
  • Patients 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 eGFR 20 to 60 mL/min/1.73 m2
  • Patients 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).
  • Patients 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 patients who can become pregnant, are pregnant or breastfeeding
  • Patients who have any of the following medical conditions (the site research staff will discuss these criteria and determine a patient'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
Both
25 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Czech Republic,   France,   Hungary,   Israel,   Puerto Rico
 
NCT01113801
10168, H9V-MC-GFRF
Yes
Eli Lilly and Company
Eli Lilly and Company
Not Provided
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP