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Study of LY3016859 in Participants With Diabetic Nephropathy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01774981
First received: January 22, 2013
Last updated: July 14, 2017
Last verified: July 2017
  Purpose
The purpose of this two-part study is to investigate the safety, tolerability and efficacy of LY3016859 after multiple intravenous (IV) dosing's in participants with diabetic nephropathy (DN). Part A will be dose escalation for safety and tolerability and Part B will evaluate Proteinuria.

Condition Intervention Phase
Diabetic Nephropathy Drug: Placebo Drug: LY3016859 Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Study of the Safety and Efficacy of LY3016859 After Multiple Intravenous Dosing in Diabetic Nephropathy Patients

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Part B:Change From Baseline in Proteinuria [ Time Frame: Baseline, 16 Weeks ]
    Proteinuria is defined as the ratio of protein to creatinine.

  • Part A and Part B: Number of Participants With One or More Treatment Emergent Adverse Events (AEs) or Any Serious AEs [ Time Frame: Baseline up to 32 Weeks ]
    Treatment-emergent adverse events (TEAEs) are events which were not present at baseline or pre-existing conditions at baseline that worsened in severity following the start of treatment. A summary of other non-serious Adverse Events (AEs), and all Serious Adverse Events (SAE's), regardless of causality, is located in the Reported Adverse Events section.


Secondary Outcome Measures:
  • Part B: Change From Baseline in Proteinuria Over Time [ Time Frame: Baseline, 19 Weeks ]
    Proteinuria is defined as the ratio of protein to creatinine.

  • Part B: Change From Baseline in Albuminuria Over Time [ Time Frame: Baseline, 19 Weeks ]
    Albuminuria is defined as the ratio of albumin to creatinine.


Enrollment: 60
Study Start Date: March 2013
Study Completion Date: August 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo (Part A)
Part A: Placebo administered by 60 minute Intravenous (IV) infusion at Week 1 and Week 4.
Drug: Placebo
Administered IV
Experimental: 10 mg LY3016859 (Part A)
Part A: 10 milligram (mg) LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4.
Drug: LY3016859
Administered IV
Experimental: 100 mg LY3016859 (Part A)
Part A: 100 mg LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4.
Drug: LY3016859
Administered IV
Experimental: 750 mg LY3016859 (Part A)
Part A: 750 mg LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4.
Drug: LY3016859
Administered IV
Placebo Comparator: Placebo (Part B)
Part B: Placebo administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
Drug: Placebo
Administered IV
Experimental: 50 mg LY3016859 (Part B)
Part B: 50 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
Drug: LY3016859
Administered IV
Experimental: 250 mg LY3016859 (Part B)
Part B: 250 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
Drug: LY3016859
Administered IV
Experimental: 750 mg LY3016859 (Part B)
Part B: 750 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13.
Drug: LY3016859
Administered IV

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Stable diabetic kidney disease (DKD) while taking Standard of Care medication (SOC), as defined by:

    • Estimated glomerular filtration rate (eGFR) less than (<) 90 milliliter per minute per 1.73 square meter (ml/min/1.73m²) as determine utilizing the Modification of Diet in Renal Disease (MDRD) equation
    • Taking an angiotensin convertible enzyme (ACE) inhibitor or angiotensin II receptor blocker (ARB) at a stable dose for greater than or equal to (≥) 2 months prior to randomization and agree to continue to take such throughout the duration of the study
    • Type 1 or Type 2 diabetes on a stable treatment regimen and adequately controlled in the opinion of the investigator
    • First morning protein-creatine ratio (PCR) at screening ≥400 milligrams per gram (mg/g) (Part B only)
  • Clinical chemistry labs within acceptable range for the participant population, as per investigator judgment
  • Men and women of non-childbearing potential as determined by medical history and physical examination

    • Non-vasectomized male participants must agree to use a medically accepted method of contraception with all sexual partners during the study and for 90 days following the final dosing. Medically accepted effective forms of contraception may include condoms with contraceptive foam or having partners use diaphragms with contraceptive jelly or cervical caps with contraceptive jelly
    • Female participants must be postmenopausal or surgically sterile to participate in this study. This is defined as females between age 45 to 75 years, inclusive, and either 12 months without a menstrual period [no follicle stimulating hormone (FSH) test required] or 6-12 months without a menstrual period and follicle stimulating hormone (FSH) greater than (>) 40 international units per liter (IU/L)
  • Must weigh ≥50 kilograms (kg) at time of screening and dosing
  • Acceptable sitting blood pressure (BP) per the following American Heart Association (AHA) guidelines:

    • Normal: systolic blood pressure (SBP) <120 millimeters of mercury (mmHg) and diastolic blood pressure (DBP) <80 mmHg
    • Prehypertension: SBP 120-139 or DBP 80-89
    • High Blood Pressure (Hypertension) Stage 1: SBP 140-159 mmHg or DBP 90-99
  • Have given written informed consent prior to any study-specific procedures
  • Are reliable and willing to make themselves available for the duration of the study and are willing to follow site specific study procedures
  • Have venous access sufficient to allow blood sampling
  • Have laboratory values and other safety parameters that are, in the opinion of the investigator, acceptable fo participation for the study

Exclusion Criteria:

  • Have a diagnosis of chronic kidney disease (CKD) other than DKD, (hypertensive nephrosclerosis superimposed on DKD is acceptable)
  • Have SBP >160 mmHg or DBP >100 mmHg

    o Individuals with Stage 1 BP elevation (SBP 140-159 mmHg or DBP 90-99 mmHg) on some occasions during study, may be acceptable, as long as only non-protein-lowering antihypertensives are adjusted to achieve target BP goals (<140/90 mmHg)

  • Current use of (or within 2 weeks of enrollment), or projected need for a renin inhibitor or aldosterone antagonist, or a combination of Angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers (ACEi/ARB)
  • Individuals in whom dialysis or transplantation is anticipated within 6 months of screening
  • Have a history of acute kidney injury within 3 months of screening
  • Are currently enrolled in, or discontinued within the last 60 days from, a clinical trial involving an investigational drug that has not received regulatory approval for any indication and/or have received treatment with biologic agents (such as monoclonal antibodies) within 3 months or 5 half-lives of the administered drug (whichever is longer) prior to dosing
  • Have previously completed or withdrawn from this study or any other study investigating LY3016859
  • Have a diagnosis of Class III or IV congestive heart failure (as defined by the New York Heart Association)
  • Have an abnormality in the 12-lead Electrocardiogram (ECG) that, in the opinion of the investigator increases the risks associated with participating in the study. In addition, individuals with the following findings will be excluded:

    • Confirmed corrected QT (QTcF) interval >450 milliseconds (msec) for men and >470 msec for women
    • Irregular rhythms other than sinus arrhythmia or occasional, rare supraventricular ectopic beats
    • History of unexplained syncope
    • Family history of unexplained sudden death or sudden death due to long QT syndrome
    • T-wave configurations are not of sufficient quality for assessing QT interval, as determined by the investigator
  • Have evidence of human immunodeficiency virus (HIV) and/or positive human HIV antibodies; have a history of cirrhosis or hepatitis C or are positive for hepatitis C antibody at the screening visit; are known to be hepatitis B surface antigen-positive or are positive for hepatitis B surface antigen at the screening visit
  • Are unwilling to discontinue use of Chinese herbs for at least 2 weeks prior to randomization and for the duration of their study participation
  • Are unwilling or unable to comply with the use of a data collection device to directly record data from the participant
  • Have donated blood of more than 500 milliliters (mL) within the last 60 days prior to screening
  • Have an average weekly alcohol intake that exceeds 21 units per week or are unwilling to stop alcohol intake within 48 hours of entry into study and for the duration of the study (1 unit = 12 ounces (oz) or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits)
  • Individuals who, in the opinion of the investigator, show evidence of regular use of drugs of abuse
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01774981

Locations
United States, Florida
Innovative Research of West Florida
Clearwater, Florida, United States, 33756
United States, Nebraska
Creighton University Medical Center
Omaha, Nebraska, United States, 68131
United States, Pennsylvania
Northeast Clinical Research Center
Bethlehem, Pennsylvania, United States, 18017
United States, Tennessee
Southeast Renal Research Institute
Chattanooga, Tennessee, United States, 37408
United States, Texas
TAD Clinical Research
Lufkin, Texas, United States, 75904
Renal Associates, PA
San Antonio, Texas, United States, 78215
Bulgaria
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.
Sofia, Bulgaria, 1612
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: NCT01774981     History of Changes
Other Study ID Numbers: 14353
I5V-MC-TGAB ( Other Identifier: Eli Lilly and Company )
2012-004496-40 ( EudraCT Number )
Study First Received: January 22, 2013
Results First Received: July 14, 2017
Last Updated: July 14, 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.


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

ClinicalTrials.gov processed this record on September 20, 2017