Study of the Safety and Efficacy in Chronic Kidney Disease Patients
- Conditions
- Chronic kidney diseaseMedDRA version: 14.1Level: LLTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 10038359 - Renal and urinary disorders
- Registration Number
- EUCTR2012-000773-23-BG
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 48
1] Men and women of non-childbearing potential as determined by medical history and PE.
[1a] male subjects: agree to use 2 medically accepted methods of contraception
[1b] female subjects: women not of child-bearing potential
[2] Have been diagnosed with CKD
3] Have an estimated glomerular filtration rate (eGFR) between 30-70 ml/min/1.73 m2
4] Have been taking an ACE inhibitor and/or ARB, for at least 3 months, and at a stable dose for =2 months prior to randomization
5] Stable use of BP medication and acceptable cuff BP
6] Have serum potassium =5.0 mEq/L (equivalent to mmol/L) at screening, and no more than 1 hospitalization due to hyperkalemia within 1 year
[7] Are 18-75 years old, inclusive
8] Have given written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 24
Patients who are currently enrolled in, or have discontinued within the last 30 days or 5 half lives (whichever is longer) of the investigational drug from, a clinical trial involving an investigational drug or device or an off-label use of an approved drug
Patients who have previously completed or withdrawn from this study or any other study investigating LY2623091.
Patients who are taking any diuretic drug and not receiving a stable dose for 3 weeks prior to the screening/qualification visit and through end of treatment
Patients receiving a renin inhibitor, or an MR antagonist must have a wash-out period of at least 1 month prior to randomization.
Patients in whom dialysis or renal transplantation is anticipated by their physician within 6 months after the screening visit.
Patients with a history of acute kidney injury within 3 months before the screening visit.
Patients who have or are expected to require systemic immunosuppression therapy within 30 days of the screening visit (except for inhalant steroids).
Patients who use oral or parenteral corticosteroids within 30 days of the screening visit.
Patients with a diagnosis of Class III or IV congestive heart failure
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.
Patients who use CYP3A4 inhibitors or inducers, potassium-sparing diuretic drugs, potassium supplements or systemic glucocorticoids within 7 days of study enrollment. Intermittent use of nonsteroidal antiinflammatory drugs (NSAIDs) is permitted, except for within 24 hours of critical urine sodium/potassium measures or during the inpatient periods, during which times NSAID use is limited to chronic use only (stable for =1 month prior to enrollment). Prostaglandin inhibitors should not be used during the inpatient periods of the study, with above exception of chronic NSAID use.
Patients who have donated blood of more than 500 mL within the last 60 days prior to screening.
Patients who have an average weekly alcohol intake that exceeds 21 units per week or subjects unwilling to stop alcohol within 48 hours of entry into study and for the duration of the study
Patients who consume natural licorice and/or natural licorice-containing products and/or regular daily consumption of grapefruit and/or grapefruit juice within 7 days of first dosing and/or anticipated consumption during the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate the effect of LY2623091 on change from baseline in proteinuria after 3 weeks of daily oral dosing in CKD patients.;Secondary Objective: •Investigate the effect of LY2623091 on potassium clearance following an oral potassium challenge in CKD patients<br><br>•Investigate the safety and tolerability of LY2623091 in CKD patients <br><br>•Explore the PK profile of LY2623091 after multiple oral dosing in CKD patients <br>;Primary end point(s): Change from Baseline to 21 days in proteinurea based on 24 hours pooled urine;Timepoint(s) of evaluation of this end point: Baseline, 21 Days of each treatment period
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Change from baseline to 21 days in<br>potassium clearance following an oral potassium challenge<br><br>Pharmacokinetics: area under the<br>concentration - time curve (AUC 0-24hr) of LY2623091<br><br>Pharmacokinetic: maximum plasma<br>concentration (Cmax) of LY2623091<br>;Timepoint(s) of evaluation of this end point: endpoint Baseline, 21 Days of each treatment<br>Period<br><br>Predose up to 24 hours Postdose on<br>Day 20 of each treatment period<br><br>Predose up to 24 hours Postdose on<br>Day 20 of each treatment period<br>