Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:48 AM
Ignite Modification Date:
2025-12-24 @ 11:48 AM
NCT ID:
NCT02299661
Eligibility Criteria:
Inclusion Criteria:
* Male and female patients aged 18 - 70 years (inclusive).
* Female patients must be of non-childbearing potential (post-menopause or surgical sterilization). In women younger than 60 years a follicle-stimulating hormone (FSH) test will be conducted to confirm post-menopausal status (i.e., FSH ≥ 30 mU/mL).
* Part A: CKD stage 3b (eGFR: \< 45 to ≥ 30 mL/min) or stage 4 (eGFR: \< 30 to ≥ 15 mL/min). The CKD-EPI equation will be used for the eGFR estimation.
* Part B: Patients on chronic haemodialysis for at least 6 months and stable Hb levels (i.e., +/- 1 g/dL) for the last 6 months.
* Patient can be washed out from ESAs for at least 3 weeks (2 weeks prior to dosing and 1 week post-dose).
* Baseline Hb level ≥10 g/dL.
* Willingness to give written consent to participate after reading the ICF, and after having the opportunity to discuss the trial with the Investigator or his delegate.
* Male patients must be willing to use a reliable method of contraception during the trial, and for 4 months afterwards
Exclusion Criteria:
* Use of ESAs within 2 weeks prior to dosing.
* Uncontrolled hypertension despite optimal medical therapy, defined as \> 160/100 mmHg after 10 minutes of rest at screening, and \> 180/110 mmHg after 10 minutes of rest on Day -1 pre-dose.
* Known haemoglobinopathy.
* Acute renal failure (as judged by the Investigator).
* History of kidney transplant regardless of functionality.
* Start of any new medication or any changes to a current dosage within 7 days prior to study drug administration.
* Chronic liver disease.
* Positive hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody test.
* Positive test for human immunodeficiency virus (HIV)-1 or HIV-2.
* A history of gastrointestinal bleeding.
* History of a thrombotic event (e.g., myocardial infarction, stroke or transient ischemic attack, peripheral embolism, venous thromboembolism, etc.)
* Patients with poorly controlled diabetes despite optimal medical therapy.
* A history of cancer, except basal cell skin cancer, squamous cell skin cancer, or cervical cancer (if judged by the Investigator to be in full remission).
* Hypersensitivity to any components of the study drug.
* Requirement for any concomitant medication that cannot be withheld on Day 1 until 4 hours post-dose (insulin is allowed to cover the breakfast, if necessary).
* Clinically relevant abnormal medical history, physical findings, ECG, or laboratory values at the screening assessments that could interfere with the objectives of the trial or the safety of the patient.
* Participation in another investigational drug trial within 30 days prior to dosing (or 5 times the half-life of the drug, whichever is longer) or exposure to more than three new investigational agents within 12 months prior to enrolment.
* Abuse of drugs or alcohol during the 2 years before the first dose of trial medication.
* Ingestion of alcohol within 72 hours prior to dosing and during confinement. Outside the in-house period, regular alcohol consumption must not exceed 16 units for males and 7 units for females per week (1 unit equals 340 mL of beer, 115 mL of wine or 43 mL of spirits).
* Positive drug screen (if not due to concomitant medication) or alcohol breath test at screening and/or Day -1.
* Patients who smoke more than 10 cigarettes per day (or equivalent), and who would not be able to abstain from smoking during the in-house period.
* Concomitant use of medications known to affect the elimination of serum creatinine (e.g., trimethoprim or cimetidine) and competitors of renal tubular secretion (e.g., probenecid) within 30 days before dosing.
* Use of a strong inducer or inhibitor of CYP enzymes, during the 30 days before dosing.
* Use of any other prohibited medication.
* Loss of more than 400 mL blood, or donation of blood, plasma, platelets, or any other blood components, during the 3 months before the trial, or unwilling to abstain from donating during the study and for 3 months after receipt of the final dose of trial medication.
* Possibility that the patient will not cooperate with the requirements of the protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02299661
Study Brief:
Protocol Section:
NCT02299661