Phase 2
Completed N=42
A Study of LY2623091 in Male and Females With Chronic Kidney Disease
Source: ClinicalTrials.gov NCT01427972 ↗Enrolled (actual)
42
Serious AEs
2.5%
Results posted
Jun 2019
Primary outcomePrimary: Change From Baseline to Day 21 in Proteinuria Based on 24-hours Pooled Urine — -98.9; -19.7; 119.4; 273.7 milligrams/24 hours (mg/24 h)
Summary
The purpose of this trial is to investigate the safety and efficacy of LY2623091 in males and females with chronic kidney disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Day 21 in Proteinuria Based on 24-hours Pooled Urine |
-98.9; -19.7; 119.4; 273.7 | — |
| SECONDARY Change From Baseline to Day 21 in Potassium Clearance Following an Oral Potassium Challenge |
0.097; -0.122; -0.174; -0.019 | — |
| SECONDARY Pharmacokinetics (PK): Area Under the Plasma Concentration Time Curve During the Dosing Period of LY2623091 (AUC0-τ) |
75.321; 526.640; 3096.658 | — |
| SECONDARY PK: Maximum Plasma Concentration (Cmax) of LY2623091 |
4.540; 31.722; 187.441 | — |
Eligibility Criteria
Inclusion Criteria
- Men and women of non-childbearing potential as determined by medical history and physical examination
- Male participants: Non-vasectomized male participants must agree to use 2 medically accepted methods 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: Female participants must be of non-childbearing potential due to surgical sterilization (hysterectomy, bilateral oophorectomy or tubal ligation) or menopause. Postmenopausal women should be a minimum of 12 months without a menstrual period. Perimenopausal women who are 6 months without a menstrual period, have a follicle stimulating hormone (FSH) level 23.0-116.3 international unit/liter (IU/L) and are between the ages of 45 and 65 years, inclusive, are also eligible
- Have been diagnosed with Chronic Kidney Disease (CKD) (and including diabetic kidney disease and chronic glomerulonephritis)
- Have an estimated glomerular filtration rate (eGFR) between 30-70 milliliter/minute/1.73 square meters(30-70 ml/min/1.73m²)
- Have been taking an angiotensin converting enzyme (ACE) inhibitor and/or angiotensin II receptor blocker (ARB), for at least 3 months, and 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
- Participants must meet both of the following renal function criteria prior to qualifying for randomization:
- Have Screening first morning urine protein/creatinine ratio (PCR) ≥400 milligram/gram (mg/g)
- Have stable renal function, in the opinion of the Investigator
- Stable use of blood pressure (BP) medication and acceptable cuff BP, as defined by the following criteria:
- While receiving stable dose of an ACE inhibitor and/or ARB
- While receiving stable doses of any other applicable BP medication (including diuretic therapy) for ≥3 weeks prior to screening
- Have seated cuff systolic BP less than or equal to (≤) 160 millimeters of mercury (mm Hg) and diastolic BP ≤100 mm Hg
- Have serum potassium (K+)≤5.0 milliequivalents/liter (mEq/L) at Screening, and no more that 1 hospitalization due to hyperkalemia within 1 year
- Are reliable and willing to make themselves available for the duration of the study and are willing to follow specific study procedures
- Have venous access sufficient to allow blood sampling
- Have lab values and other safety parameters that are, in the opinion of the investigator, acceptable for participation in the study
Exclusion Criteria
- Participants who are currently enrolled in, or have discontinued within the last 30 days of the investigational drug from, a clinical trial involving an investigational drug or device or an off-label use of an approved drug (other than the study drug used in this study), or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. Participants may be enrolled in this study and dosed on day 31 or greater following the last day of previous investigational drug administration
- Have previously completed or withdrawn from this study or any other study investigating LY2623091
- Participants 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
- Participants receiving a renin inhibitor, or an mineralocorticoid receptor (MR) antagonist must have a wash-out period of at least 1 month prior to randomization
- Participants in whom dialysis or renal transplantation is anticipated by their physician within 6 months after the Screening
- Participants with a history of acute kidney injury within 3 months before Screening
- Participants who have or are e
Data sourced from ClinicalTrials.gov (NCT01427972). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.