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 @ 9:20 PM
Ignite Modification Date:
2025-12-24 @ 9:20 PM
NCT ID:
NCT00602004
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosis of CKD at near-end stage renal failure (CKD Stage IV) ( eGFR = 15-30 mls/min).
2. Age \>18 years of age and \<85 years of age.
3. Males and post-menopausal, sterile women. Non-pregnant pre-menopausal women should be on adequate contraception and have no intention of becoming pregnant during the duration of the study.
4. At baseline TTE LVEF\>45%
5. Willing and able to give informed consent.
Exclusion Criteria:
1. Serum potassium level of more than 5.5 mmol/L
2. Acute myocardial infarction or cerebrovascular accident in the previous 6 months.
3. Severe uncontrolled hypertension (diastolic BP \>100mmHg or systolic BP \>160 mmHg)
4. Evidence or suspicion of renovascular disease.
5. Atrial fibrillation
6. Evidence or suspicion of collagen disease, cancer, psychiatric disorder that interferes with patient compliance, drug or alcohol abuse, pregnancy, breast feeding and ineffective contraception.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00602004
Study Brief:
Protocol Section:
NCT00602004