Chronic kidney disease associated with Diabetic nephropathy MedDRA version: 14.1 Level: LLT Classification code 10064848 Term: Chronic kidney disease System Organ Class: 100000004857 MedDRA version: 14.1 Level: LLT Classification code 10012678 Term: Diabetic nephropathy NOS System Organ Class: 100000004857
Conditions
Interventions
Product Name: Not yet avaliable
Product Code: LY3016859
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: N/A
Current Spon
Anti-TGF-alpha/Epiregulin Antibody
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 10 -750
Pharmaceu
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Stable DKD while taking SOC, as defined by: a. Estimated glomerular filtration rate (eGFR) 40 IU/L 4. 18-75 years old, inclusive and must weigh = 50 kg at time of screening and dosing. 5. Acceptable sitting blood pressure per the following American Heart Association guidelines a. Normal: Systolic Blood Pressure (SBP) =65 years) yes F.1.3.1 Number of subjects for this age range 24
Exclusion criteria
Exclusion criteria: 1. Patients with diagnosis of CKD other than DKD (hypertensive nephrosclerosis superimposed on DKD is acceptable) 2. Patients with SBP >160 mmHg or DBP >100 mmHg, a. Individuals with Stage I 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 administered/adjusted to achieve target BP goals ( 450 msec for men and > 470 msec for women; additional ECGs may be performed if required b. Irregular rhythms other than sinus arrhythmia or occasional, rare supraventricular ectopic beats c. History of unexplained syncope d. Family history of unexplained sudden death or sudden death due to long QT syndrome e. T-wave configurations are not of sufficient quality for assessing QT interval, as determined by the investigator 10. Patients with evidence of human immunodeficiency virus (HIV) and/or positive human HIV antibodies; patients with a history of cirrhosis or hepatitis C or are positive for hepatitis C antibody at the screening visit; patients who are known to be hepatitis B surface antigen-positive or are positive for hepatitis B surface antigen at the screening visit 11. Patients who are unwilling to discontinue use of Chinese herbs for at least 2 weeks prior to randomization and for the duration of their study pa
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To investigate the effect of LY3016859 on change from baseline in proteinuria and albuminuria over time (Part B only); Primary end point(s): Number of participants with clinically significant effects (Parts A and B) and change from baseline in proteinuria (Part B) ; Timepoint(s) of evaluation of this end point: Safety: Baseline to 6 and 12 weeks post last dose for Parts A and B, respectively; Proteinuria: Baseline to 16 weeks ; Main Objective: To investigate the safety and tolerability of multiple IV doses of LY3016859 in DN patients To evaluate the effect of multiple IV dosing of LY3016859 on change from baseline in proteinuria at 16 weeks in DN patients (Part B only) | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Baseline to 16 weeks; Secondary end point(s): Change from baseline in proteinuria and albuminuria | — |
Countries
Bulgaria, United Kingdom
Contacts
Public ContactClinical Trial Information
Eli Lilly and Company Ltd.
Outcome results
None listed