Chronic kidney disease associated with Diabetic nephropathy MedDRA version: 16.1 Level: LLT Classification code 10064848 Term: Chronic kidney disease System Organ Class: 100000004857 MedDRA version: 16.1 Level: LLT Classification code 10012678 Term: Diabetic nephropathy NOS System Organ Class: 100000004857
Conditions
Interventions
Product Name: Not yet available
Product Code: LY3016859
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: N/A
CAS Number: N/A
Current Sponsor code: LY3016859
Other descriptive name: LA49
anti-TGF-alpha/Epiregulin monoclonal antibody
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-
Pharmaceutical form of the placebo: Solution for infusion
Route of
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 (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, despite adjustment of the antihypertensive regimen, confirmed upon repeat assessment 3. Patients with current use of (or within 2 weeks of enrollment), or projected need for a renin inhibitor or aldosterone antagonist, or a combination of ACEi/ARB or medications that confound the assessment of renal function, including lithium, immunosuppressives, anti-vascular endothelial growth factor (VEGF) therapies, and chronic nonsteroidal anti-inflammatory drugs (NSAIDs); Patients who are unwilling to discontinue use of any medication with potential to mask a significant allergic response (e.g. systemic glucocorticoids) within 3 days of dosing; 4. Patients in whom dialysis or transplantation is anticipated within 6 months of screening 5. Patients with history of acute kidney injury within 3 months of screening 6. Patients who 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 7. Patients who have previously completed or withdrawn from this study or any other study investigating LY3016859 8. Patients with a diagnosis of Class III or IV congestive heart failure (as defined by the New York Heart Association); active/significant skin disorders (dermatitis, rash, acne, psoriasis), lung diseases (asthma, COPD, interstitial lung disease), or ocular disorders affecting sclerae, conjunctiva or iris (scleritis, conjunctivitis, keratoconjunctivitis, uveitis). 9. Patients with an abnormality in the 12-lead ECG that, in the opinion of the investigator, increases the risks associated with participating in the study. In addition, subjects with the following findings will be excluded: a. Confirmed corrected QT (QTcF) interval > 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 participation. 12. Patients who are investigator site personnel directly affiliated with this study and/or members of their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted 13. Patients who are Lilly or Chorus employees or contractors or their immediate family members 14. Patients who are unwilling or unable to comply with the use of a data collection device to di
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change from baseline in proteinuria and albuminuria;Timepoint(s) of evaluation of this end point: Baseline to 16 weeks | — |
Countries
Bulgaria, United Kingdom, United States
Contacts
Public ContactClinical Trial Information
Eli Lillyand Company
Outcome results
None listed