A study evaluating the safety of LHW090 in patients with kidney disorder
- Conditions
- Moderate renal impairmentMedDRA version: 20.0 Level: PT Classification code 10062237 Term: Renal impairment System Organ Class: 10038359 - Renal and urinary disordersTherapeutic area: Not possible to specify
- Registration Number
- EUCTR2015-004570-15-DE
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 84
1. Written informed consent must be obtained before any assessment is performed.
2. Male and female patients, age 40 to 85 years of age (inclusive) on a stable (at least 1 month) dose of an angiotensin receptor blocker (ARB) and stable moderately impaired renal function, defined here as an eGFR 30-59 mL/min/1.73m2 (inclusive) using the 4 variable MDRD Study equation for at least 3 months.
3. At screening, vital signs (systolic and diastolic blood pressure and pulse rate) will be assessed in the sitting position after the patient has rested for at least five minutes and again after three minutes in the standing position.
Sitting vital signs should be within the following ranges:
- oral body temperature between 35.0-37.5 °C,
-systolic blood pressure, 100-170 mm Hg,
- diastolic blood pressure, 50-100 mm Hg
- pulse rate, 50 - 95 bpm
4. Patients must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 - 40kg/m2. BMI = Body weight (kg) / [Height (m)]2.
5. Able to communicate well with the investigator, to understand and comply with the requirements of the study.
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 42
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 42
1. Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or until the expected PD effect has returned to baseline, whichever is longer; or longer if required by local regulations.
2. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
3. History of angioedema, drug-related or otherwise, as reported by the patient.
4. Use of angiotensin converting enzyme inhibitors (ACE inhibitors), mineralocorticoid receptor antagonists (e.g. spironolactone or eplerenone), aliskiren, vasopressin receptor antagonists (e.g. tolvaptan), or oral alkalinizing agents (e.g. sodium and potassium citrate or Shohl's solution).
5. History of a renal transplant.
6. Known current significant left ventricular outflow obstruction, such as obstructive hypertrophic cardiomyopathy or significant severe valvular disease on prior or current echocardiogram.
7. A history of clinically significant ECG abnormalities, as determined by the Investigator, or any of the following ECG abnormalities at screening? •?QTcF > 480 msec
8. Known history or current clinically significant arrhythmias.
9. History within the previous 6 months of myocardial infarction, coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI), stroke, transient ischemic attack (TIA) or acute kidney injury.
10. Hemoglobin levels below 9.0 g/dL at screening.
11. A serum potassium = 3.5 mmol/l or = 5.5 mmol/l at screening.
12. A previous history or previously diagnosed kidney disorder, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study or is likely to confound the interpretation of the study results. Such kidney disorders may include renal cystic disease such as autosomal dominant polycystic kidney disease (history of an incidental asymptomatic acquired renal cyst(s) is excepted); obstructive uropathy; renal stone(s) in the past 2 years; chronic interstitial nephropathy; drug-induced nephropathy; residual renal insufficiency following an episode of acute kidney injury or acute tubular necrosis related to renal atheroembolic disease, septic shock or ischemic nephropathy; renal tubular acidosis requiring treatment; nephrotic syndrome or nephrotic range proteinuria; or renal artery stenosis.
13. Donation or loss of 400 mL or more of blood within 8 weeks prior to initial dosing, or longer if required by local regulations.
14. Significant illness which has not resolved within two (2) weeks prior to initial dosing.
15. History of immunodeficiency diseases, including a positive HIV test result.
16. A positive Hepatitis B surface antigen or Hepatitis C test result.
17. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
18. Pregnant or nursing (lactating) women.
19. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant.
20. Sexually active males unwilling to use a condom during intercourse while taking
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method