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A Study in Participants With Diabetic Kidney Disease

This study has been terminated.
(Interim Assessment: Lack of Efficacy)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01113801
First Posted: April 30, 2010
Last Update Posted: December 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eli Lilly and Company
April 28, 2010
April 30, 2010
September 27, 2017
December 13, 2017
December 13, 2017
July 2010
May 2014   (Final data collection date for primary outcome measure)
Change in Log Transformed (In) Serum Creatinine From Baseline to 12 Month Endpoint [ Time Frame: Baseline, 12 months ]
Analysis of covariance (ANCOVA) model was used with treatment, visit, and treatment-by-visit interaction as fixed effects, subject as random effect, baseline Serum Creatinine log transformed (ln) and first morning urine protein to creatinine ratio (PCR) log transformed (ln) as covariates.
Change in Serum Creatinine from baseline to 12 month endpoint [ Time Frame: Baseline, 12 months ]
Complete list of historical versions of study NCT01113801 on ClinicalTrials.gov Archive Site
  • Change in Log Transformed (ln) Urine Protein/Creatinine Ratio From Baseline to 12 Month Endpoint [ Time Frame: Baseline, 12 months ]
    Analysis of covariance (ANCOVA) model was used with treatment, visit, and treatment-by-visit interaction as fixed effects, subject as random effect, baseline Serum Creatinine log transformed (ln) and first morning urine protein to creatinine ratio (PCR) log transformed (ln) as covariates.
  • Population Pharmacokinetics (PK) - Model-Estimated Area Under the Concentration -Time Curve (AUC ) Over a Dosing Interval [ Time Frame: Baseline through 12 months (samples collected pre and/or postdose at monthly intervals) ]
  • Log Transformed (ln) Serum Creatinine Slope of Change From Baseline Through 12 Months [ Time Frame: Baseline through 12 months ]
    Analysis of covariance (ANCOVA) model was used with treatment as fixed effects and baseline Serum Creatinine log transformed (ln) and first morning urine protein to creatinine ratio (PCR) log transformed (ln) as covariates.
  • Estimated Glomerular Filtration Rate (eGFR) Slope of Change From Baseline Through 12 Months [ Time Frame: Baseline through 12 months ]
    Analysis of covariance (ANCOVA) model was used with treatment as fixed effects, baseline Serum Creatinine log transformed (ln) and first morning urine protein to creatinine ratio (PCR) ) log transformed (ln) as covariates.
  • Change in Urine Protein/Creatinine Ratio from baseline to 12 month endpoint [ Time Frame: Baseline, 12 months ]
  • Population PK [ Time Frame: Baseline through 12 months ]
  • Serum creatinine slope of change from baseline through 12 months [ Time Frame: Baseline through 12 months ]
Not Provided
Not Provided
 
A Study in Participants 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 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).
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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.
 
Terminated
417
July 2014
May 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
25 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Czechia,   France,   Hungary,   Israel,   Puerto Rico,   United States
Czech Republic
 
NCT01113801
10168
H9V-MC-GFRF ( Other Identifier: Eli Lilly and Company )
Yes
Not Provided
Plan to Share IPD: Yes
Plan Description:

Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.

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
November 2017

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