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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
  Purpose
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.

Condition Intervention Phase
Diabetic Kidney Disease Diabetic Nephropathy Diabetic Glomerulosclerosis Drug: LY2382770 Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 417
Study Start Date: July 2010
Study Completion Date: July 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Subcutaneous injection given monthly for 12 months
Experimental: 2 mg LY2382770 Drug: LY2382770
Subcutaneous injection given monthly for 12 months
Experimental: 10 mg LY2382770 Drug: LY2382770
Subcutaneous injection given monthly for 12 months
Experimental: 50 mg LY2382770 Drug: LY2382770
Subcutaneous injection given monthly for 12 months

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).
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   25 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01113801


  Show 78 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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
  More Information

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01113801     History of Changes
Other Study ID Numbers: 10168
H9V-MC-GFRF ( Other Identifier: Eli Lilly and Company )
First Submitted: April 28, 2010
First Posted: April 30, 2010
Results First Submitted: September 27, 2017
Results First Posted: December 13, 2017
Last Update Posted: December 13, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
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.


Keywords provided by Eli Lilly and Company:
Chronic Kidney Disease
Diabetic Kidney Disease
End-Stage Renal Disease
Transforming Growth Factor beta 1 Monoclonal Antibody
Type 1 Diabetes
Type 2 Diabetes

Additional relevant MeSH terms:
Kidney Diseases
Diabetic Nephropathies
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases