NCT01113801

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
417

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2010

Typical duration for phase_2

Geographic Reach
7 countries

78 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 30, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

December 13, 2017

Completed
Last Updated

September 17, 2019

Status Verified

September 1, 2019

Enrollment Period

3.8 years

First QC Date

April 28, 2010

Results QC Date

September 27, 2017

Last Update Submit

September 9, 2019

Conditions

Diabetic Kidney DiseaseDiabetic NephropathyDiabetic Glomerulosclerosis

Keywords

Chronic Kidney DiseaseDiabetic Kidney DiseaseEnd-Stage Renal DiseaseTransforming Growth Factor beta 1 Monoclonal AntibodyType 1 DiabetesType 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline, 12 months

Secondary Outcomes (4)

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

    Baseline, 12 months

  • 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

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

    Baseline through 12 months

Study Arms (4)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

2 mg LY2382770

EXPERIMENTAL
Drug: LY2382770

10 mg LY2382770

EXPERIMENTAL
Drug: LY2382770

50 mg LY2382770

EXPERIMENTAL
Drug: LY2382770

Interventions

LY2382770DRUG

Subcutaneous injection given monthly for 12 months

10 mg LY23827702 mg LY238277050 mg LY2382770
PlaceboDRUG

Subcutaneous injection given monthly for 12 months

Placebo

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (78)

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Phoenix, Arizona, 85012, United States

Location

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Inglewood, California, 90301, United States

Location

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Los Angeles, California, 90073, United States

Location

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Northridge, California, 91324, United States

Location

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Denver, Colorado, 80220, United States

Location

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Port Charlotte, Florida, 33952, United States

Location

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Tampa, Florida, 33614, United States

Location

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Atlanta, Georgia, 30342, United States

Location

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Idaho Falls, Idaho, 83404, United States

Location

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Wichita, Kansas, 67214, United States

Location

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Kenner, Louisiana, 70065, United States

Location

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Rockville, Maryland, 20852, United States

Location

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Kansas City, Missouri, 64128, United States

Location

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Omaha, Nebraska, 68131, United States

Location

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Chapel Hill, North Carolina, 27599, United States

Location

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Charlotte, North Carolina, 28207, United States

Location

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Durham, North Carolina, 27705, United States

Location

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Greenville, North Carolina, 27834, United States

Location

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Winston-Salem, North Carolina, 27157, United States

Location

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Beachwood, Ohio, 44122, United States

Location

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Bend, Oregon, 97701, United States

Location

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Providence, Rhode Island, 02903, United States

Location

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Orangeburg, South Carolina, 29118, United States

Location

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Dallas, Texas, 75390, United States

Location

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Lufkin, Texas, 75904, United States

Location

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St. George, Utah, 84770, United States

Location

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Suffolk, Virginia, 23435, United States

Location

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Milwaukee, Wisconsin, 53295, United States

Location

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Camperdown, New South Wales, 2050, Australia

Location

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Concord, New South Wales, 2139, Australia

Location

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Gosford, New South Wales, 2250, Australia

Location

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Liverpool, New South Wales, 2170, Australia

Location

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Adelaide, South Australia, 5000, Australia

Location

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Launceston, Tasmania, 7250, Australia

Location

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Box Hill, Victoria, 3128, Australia

Location

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Fitzroy, Victoria, 3065, Australia

Location

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Heidelberg, Victoria, 3084, Australia

Location

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Melbourne, Victoria, 3004, Australia

Location

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Parkville, Victoria, 3050, Australia

Location

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Reservoir, Victoria, 3073, Australia

Location

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Nedlands, Western Australia, 6009, Australia

Location

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Český Krumlov, 381 27, Czechia

Location

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Děčín, 405 99, Czechia

Location

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Jilemnice, 514 15, Czechia

Location

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Liberec, 460 63, Czechia

Location

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Ostrava, 703 84, Czechia

Location

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Prague, 181 02, Czechia

Location

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Tábor, 390 02, Czechia

Location

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Teplice, 415 01, Czechia

Location

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Grenoble, 38043, France

Location

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Lyon, 69437, France

Location

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Nanterre, 92014, France

Location

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Valenciennes, 59322, France

Location

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Vandœuvre-lès-Nancy, 54511, France

Location

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Baja, 6500, Hungary

Location

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Balatonfüred, 8230, Hungary

Location

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Budapest, 1096, Hungary

Location

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Gyöngyös, 3200, Hungary

Location

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Győr, 9023, Hungary

Location

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Kaposvár, 7400, Hungary

Location

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Nagykanizsa, 8800, Hungary

Location

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Szeged, 6720, Hungary

Location

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Szigetvár, 7900, Hungary

Location

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Zalaegerszeg, 8900, Hungary

Location

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Ashkelon, 78278, Israel

Location

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Hadera, 38100, Israel

Location

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Haifa, 31096, Israel

Location

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Holon, 58100, Israel

Location

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Jerusalem, 91120, Israel

Location

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Kfar Saba, 44281, Israel

Location

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Nahariya, 22100, Israel

Location

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Rehovot, 76100, Israel

Location

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Safed, 13110, Israel

Location

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Tel Aviv, 64239, Israel

Location

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Tel Litwinsky, 52621, Israel

Location

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Ẕerifin, 70300, Israel

Location

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Cidra, 00739, Puerto Rico

Location

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Rio Piedras, 000935, Puerto Rico

Location

MeSH Terms

Conditions

Diabetic NephropathiesRenal Insufficiency, ChronicKidney Failure, ChronicDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesRenal InsufficiencyChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesAutoimmune DiseasesImmune System Diseases

Limitations and Caveats

Study was stopped early for efficacy futility per recommendation by the independent Data Safety Monitoring Committee.

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

Study Officials

  • 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

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2010

First Posted

April 30, 2010

Study Start

July 1, 2010

Primary Completion

May 1, 2014

Study Completion

July 1, 2014

Last Updated

September 17, 2019

Results First Posted

December 13, 2017

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, 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.
More information

Locations

HU(10)PR(2)US(28)CZ(8)AU(13)FR(5)IL(12)