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 @ 6:49 PM
Ignite Modification Date:
2025-12-24 @ 6:49 PM
NCT ID:
NCT01129557
Eligibility Criteria:
Inclusion Criteria:
* Proteinuria \> 300 mg/day
* Normal to mildly reduced kidney function (eGFR \> 45 ml/min/1.73m2)
* Systolic blood pressure \>130 mm Hg
* Diastolic blood pressure \>70 mm Hg
* Diagnoses of diabetic nephropathy, hypertensive nephrosclerosis, IgA nephropathy, focal segmental glomerulosclerosis, membranoproliferative glomerulonephritis, membranous nephropathy, fibrillary glomerulonephritis, or obesity-associated glomerulopathy
Exclusion Criteria:
* Concomitant use of cyclosporine (which can interact with aliskiren)
* Inability to undergo 6 week washout period if already on RAAS-blocking drug(s) (includes renin inhibitor, ACE-inhibitor, ARB, and mineralocorticoid receptor blocker)
* eGFR \< 45 ml/min/1.73m2
* Urine protein excretion \< 300 mg/day
* Serum K \> 5.0 mEq/l
* Systolic blood pressure \> 170 mm Hg or \< 130 mm Hg after washout period
* Diastolic blood pressure \> 110 mm Hg or \< 70 mm Hg after washout period
* Congestive heart failure NYHA class III and IV
* History of any cardiovascular events (stroke, TIA, MI, unstable angina, CABG, PCI, CHF hospitalization) in 3 months prior to study visit 1
* 2nd or 3rd degree heart block without a pacemaker or other uncontrolled arrhythmia
* Clinically significant valvular disease
* Known renal artery stenosis
* Any surgical or medical condition that might significantly alter the pharmacokinetics of the study drugs (n.b. bariatric surgery \> 6 months prior to visit 1 is not an exclusion)
* History or evidence of drug or alcohol abuse within the last 12 months
* Any concurrent life threatening condition with a life expectancy less than 2 years
* Pregnant or nursing (lactating) women
* Women of child-bearing potential unless postmenopausal for at least 1 year, surgically sterile, or using effective methods of contraception as defined by local health authorities
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01129557
Study Brief:
Protocol Section:
NCT01129557