A Study in Participants With Diabetic Kidney Disease

Phase 2

Terminated

• Conditions: Diabetic Kidney Disease; Diabetic Nephropathy; Diabetic Glomerulosclerosis
• Interventions: Drug: LY2382770; Drug: Placebo

• Registration Number: NCT01113801
• Lead Sponsor: Eli Lilly and Company

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 Timeline

• Study First Submitted: 2010-04-28
• Study First Submitted QC: 2010-04-28
• Study First Posted: 2010-04-30
• Study Start: 2010-07
• Primary Completion: 2014-05
• Study Completion: 2014-07
• Disposition First Submitted: 2014-09-29
• Disposition First Submitted QC: 2014-09-29
• Disposition First Posted: 2014-10-08
• Results First Submitted: 2017-09-27
• Results First Submitted QC: 2017-11-17
• Results First Posted: 2017-12-13
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-09
• Last Update Posted: 2019-09-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 417

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2 mg LY2382770	LY2382770	-
10 mg LY2382770	LY2382770	-
50 mg LY2382770	LY2382770	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change in Log Transformed (In) Serum Creatinine From Baseline to 12 Month Endpoint	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

Name	Time	Method
Change in Log Transformed (ln) Urine Protein/Creatinine Ratio From Baseline to 12 Month Endpoint	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	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	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	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.

Trial Locations

Locations (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.; 🇵🇷 Rio Piedras, Puerto Rico