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Trial record 1 of 1 for:    NCT01113801
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A Study in Participants With Diabetic Kidney Disease

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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetic Kidney Disease Diabetic Nephropathy Diabetic Glomerulosclerosis Drug: LY2382770 Drug: Placebo Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 417 participants
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
Study Start Date : July 2010
Actual Primary Completion Date : May 2014
Actual Study Completion Date : July 2014

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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) ]
  3. 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.

  4. 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.


Eligibility Criteria
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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
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
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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


Locations
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Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01113801    
Other Study ID Numbers: 10168
H9V-MC-GFRF ( Other Identifier: Eli Lilly and Company )
First Posted: April 30, 2010    Key Record Dates
Results First Posted: December 13, 2017
Last Update Posted: September 17, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
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
Statistical Analysis Plan (SAP)
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/
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:
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Kidney Diseases
Diabetic Nephropathies
Urologic Diseases
 Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases