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A Study in Participants With Diabetic Kidney Disease

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.
 
ClinicalTrials.gov Identifier: NCT01113801
Recruitment Status : Terminated (Interim Assessment: Lack of Efficacy)
First Posted : April 30, 2010
Results First Posted : December 13, 2017
Last Update Posted : September 17, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE April 28, 2010
First Posted Date  ICMJE April 30, 2010
Results First Submitted Date  ICMJE September 27, 2017
Results First Posted Date  ICMJE December 13, 2017
Last Update Posted Date September 17, 2019
Study Start Date  ICMJE July 2010
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 17, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 28, 2010)
Change in Serum Creatinine from baseline to 12 month endpoint [ Time Frame: Baseline, 12 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 17, 2017)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 28, 2010)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study in Participants With Diabetic Kidney Disease
Official Title  ICMJE 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
Brief Summary 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.
Detailed 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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetic Kidney Disease
  • Diabetic Nephropathy
  • Diabetic Glomerulosclerosis
Intervention  ICMJE
  • Drug: LY2382770
    Subcutaneous injection given monthly for 12 months
  • Drug: Placebo
    Subcutaneous injection given monthly for 12 months
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 4, 2015)
417
Original Estimated Enrollment  ICMJE
 (submitted: April 28, 2010)
400
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Czechia,   France,   Hungary,   Israel,   Puerto Rico,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT01113801
Other Study ID Numbers  ICMJE 10168
H9V-MC-GFRF ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: https://vivli.org/
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Eli Lilly and Company
Verification Date September 2019

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