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A Study in Participants With Diabetic Kidney Disease

Primary Purpose

Diabetic Kidney Disease, Diabetic Nephropathy, Diabetic Glomerulosclerosis

Status

Terminated

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

LY2382770

Placebo

About this trial

This is an interventional treatment trial for Diabetic Kidney Disease focused on measuring Chronic Kidney Disease, Diabetic Kidney Disease, End-Stage Renal Disease, Transforming Growth Factor beta 1 Monoclonal Antibody, Type 1 Diabetes, Type 2 Diabetes

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

2 mg LY2382770

10 mg LY2382770

50 mg LY2382770

Arm Description

Outcomes

Primary Outcome Measures

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

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

Population Pharmacokinetics (PK) - Model-Estimated Area Under the Concentration -Time Curve (AUC ) Over a Dosing Interval

Log Transformed (ln) Serum Creatinine Slope of Change From 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

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.

Full Information

NCT ID

NCT01113801

First Posted

April 28, 2010

Last Updated

September 9, 2019

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT01113801

Brief Title

A Study in Participants With Diabetic Kidney Disease

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 Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Terminated

Why Stopped

Interim Assessment: Lack of Efficacy

Study Start Date

July 2010 (undefined)

Primary Completion Date

May 2014 (Actual)

Study Completion Date

July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Kidney Disease, Diabetic Nephropathy, Diabetic Glomerulosclerosis

Keywords

Chronic Kidney Disease, Diabetic Kidney Disease, End-Stage Renal Disease, Transforming Growth Factor beta 1 Monoclonal Antibody, Type 1 Diabetes, Type 2 Diabetes

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

417 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Title

2 mg LY2382770

Arm Type

Experimental

Arm Title

10 mg LY2382770

Arm Type

Experimental

Arm Title

50 mg LY2382770

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

LY2382770

Intervention Description

Subcutaneous injection given monthly for 12 months

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Subcutaneous injection given monthly for 12 months

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Baseline, 12 months

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

Baseline, 12 months

Title

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)

Title

Log Transformed (ln) Serum Creatinine Slope of Change From Baseline Through 12 Months

Description

Time Frame

Baseline through 12 months

Title

Estimated Glomerular Filtration Rate (eGFR) Slope of Change From Baseline Through 12 Months

Description

Time Frame

Baseline through 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

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.

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85012

Country

United States

Facility Name

City

Inglewood

State/Province

California

ZIP/Postal Code

90301

Country

United States

Facility Name

City

Los Angeles

State/Province

California

ZIP/Postal Code

90073

Country

United States

Facility Name

City

Northridge

State/Province

California

ZIP/Postal Code

91324

Country

United States

Facility Name

City

Denver

State/Province

Colorado

ZIP/Postal Code

80220

Country

United States

Facility Name

City

Port Charlotte

State/Province

Florida

ZIP/Postal Code

33952

Country

United States

Facility Name

City

Tampa

State/Province

Florida

ZIP/Postal Code

33614

Country

United States

Facility Name

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

Facility Name

City

Idaho Falls

State/Province

Idaho

ZIP/Postal Code

83404

Country

United States

Facility Name

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67214

Country

United States

Facility Name

City

Kenner

State/Province

Louisiana

ZIP/Postal Code

70065

Country

United States

Facility Name

City

Rockville

State/Province

Maryland

ZIP/Postal Code

20852

Country

United States

Facility Name

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64128

Country

United States

Facility Name

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68131

Country

United States

Facility Name

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599

Country

United States

Facility Name

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28207

Country

United States

Facility Name

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27705

Country

United States

Facility Name

City

Greenville

State/Province

North Carolina

ZIP/Postal Code

27834

Country

United States

Facility Name

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

Facility Name

City

Beachwood

State/Province

Ohio

ZIP/Postal Code

44122

Country

United States

Facility Name

City

Bend

State/Province

Oregon

ZIP/Postal Code

97701

Country

United States

Facility Name

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02903

Country

United States

Facility Name

City

Orangeburg

State/Province

South Carolina

ZIP/Postal Code

29118

Country

United States

Facility Name

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390

Country

United States

Facility Name

City

Lufkin

State/Province

Texas

ZIP/Postal Code

75904

Country

United States

Facility Name

City

Saint George

State/Province

Utah

ZIP/Postal Code

84770

Country

United States

Facility Name

City

Suffolk

State/Province

Virginia

ZIP/Postal Code

23435

Country

United States

Facility Name

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53295

Country

United States

Facility Name

City

Camperdown

State/Province

New South Wales

ZIP/Postal Code

2050

Country

Australia

Facility Name

City

Concord

State/Province

New South Wales

ZIP/Postal Code

2139

Country

Australia

Facility Name

City

Gosford

State/Province

New South Wales

ZIP/Postal Code

2250

Country

Australia

Facility Name

City

Liverpool

State/Province

New South Wales

ZIP/Postal Code

2170

Country

Australia

Facility Name

City

Adelaide

State/Province

South Australia

ZIP/Postal Code

5000

Country

Australia

Facility Name

City

Launceston

State/Province

Tasmania

ZIP/Postal Code

7250

Country

Australia

Facility Name

City

Box Hill

State/Province

Victoria

ZIP/Postal Code

3128

Country

Australia

Facility Name

City

Fitzroy

State/Province

Victoria

ZIP/Postal Code

3065

Country

Australia

Facility Name

City

Heidelberg

State/Province

Victoria

ZIP/Postal Code

3084

Country

Australia

Facility Name

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3004

Country

Australia

Facility Name

City

Parkville

State/Province

Victoria

ZIP/Postal Code

3050

Country

Australia

Facility Name

City

Reservoir

State/Province

Victoria

ZIP/Postal Code

3073

Country

Australia

Facility Name

City

Nedlands

State/Province

Western Australia

ZIP/Postal Code

6009

Country

Australia

Facility Name

City

Cesky Krumlov

ZIP/Postal Code

381 27

Country

Czechia

Facility Name

City

Decin

ZIP/Postal Code

405 99

Country

Czechia

Facility Name

City

Jilemnice

ZIP/Postal Code

514 15

Country

Czechia

Facility Name

City

Liberec

ZIP/Postal Code

460 63

Country

Czechia

Facility Name

City

Ostrava

ZIP/Postal Code

703 84

Country

Czechia

Facility Name

City

Prague

ZIP/Postal Code

181 02

Country

Czechia

Facility Name

City

Tabor

ZIP/Postal Code

390 02

Country

Czechia

Facility Name

City

Teplice

ZIP/Postal Code

415 01

Country

Czechia

Facility Name

City

Grenoble

ZIP/Postal Code

38043

Country

France

Facility Name

City

Lyon

ZIP/Postal Code

69437

Country

France

Facility Name

City

Nanterre Cedex

ZIP/Postal Code

92014

Country

France

Facility Name

City

Valenciennes

ZIP/Postal Code

59322

Country

France

Facility Name

City

Vandoeuvre Les Nancy

ZIP/Postal Code

54511

Country

France

Facility Name

City

Baja

ZIP/Postal Code

6500

Country

Hungary

Facility Name

City

Balatonfured

ZIP/Postal Code

8230

Country

Hungary

Facility Name

City

Budapest

ZIP/Postal Code

1096

Country

Hungary

Facility Name

City

Gyongyos

ZIP/Postal Code

3200

Country

Hungary

Facility Name

City

Gyor

ZIP/Postal Code

9023

Country

Hungary

Facility Name

City

Kaposvar

ZIP/Postal Code

7400

Country

Hungary

Facility Name

City

Nagykanizsa

ZIP/Postal Code

8800

Country

Hungary

Facility Name

City

Szeged

ZIP/Postal Code

6720

Country

Hungary

Facility Name

City

Szigetvar

ZIP/Postal Code

7900

Country

Hungary

Facility Name

City

Zalaegerszeg

ZIP/Postal Code

8900

Country

Hungary

Facility Name

City

Ashkelon

ZIP/Postal Code

78278

Country

Israel

Facility Name

City

Hadera

ZIP/Postal Code

38100

Country

Israel

Facility Name

City

Haifa

ZIP/Postal Code

31096

Country

Israel

Facility Name

City

Holon

ZIP/Postal Code

58100

Country

Israel

Facility Name

City

Jerusalem

ZIP/Postal Code

91120

Country

Israel

Facility Name

City

Kfar Saba

ZIP/Postal Code

44281

Country

Israel

Facility Name

City

Nahariya

ZIP/Postal Code

22100

Country

Israel

Facility Name

City

Rehovot

ZIP/Postal Code

76100

Country

Israel

Facility Name

City

Safed

ZIP/Postal Code

13110

Country

Israel

Facility Name

City

Tel Aviv

ZIP/Postal Code

64239

Country

Israel

Facility Name

City

Tel Hashomer

ZIP/Postal Code

52621

Country

Israel

Facility Name

City

Zerifin

ZIP/Postal Code

70300

Country

Israel

Facility Name

City

Cidra

ZIP/Postal Code

00739

Country

Puerto Rico

Facility Name

City

Rio Piedras

ZIP/Postal Code

000935

Country

Puerto Rico

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing URL

https://vivli.org/

Learn more about this trial

A Study in Participants With Diabetic Kidney Disease

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