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:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 1:20 AM
NCT ID:
NCT00870493
Eligibility Criteria:
Inclusion Criteria:
* aged 18-65 years
* requires anti-hypertensive therapy
* renal biopsy within the past 3 years and confirmed the diagnosis of IgA nephropathy
* proteinuria \> 1 g/day (or proteinuria \> 1 g/g-Cr) in 3 consecutive samples within 12 weeks despite ACE inhibitor or ARB treatment for at least 3 months
* estimated glomerular filtration rate \> 30 ml/min/1.73m2
* willingness to give written consent and comply with the study protocol
Exclusion Criteria:
* Patients who are diabetic, and patients with systemic diseases that may cause IgA nephropathy or another nephropathy.
* Pregnancy, lactating or childbearing potential without effective method of birth control
* Severe gastrointestinal disorders that interfere with their ability to receive or absorb oral medication
* History of malignancy, including leukemia and lymphoma within the past 2 years
* Systemic infection requiring therapy at study entry
* Any other severe coexisting disease such as, but not limited to, chronic liver disease, myocardial infarction, cerebrovascular accident, malignant hypertension
* History of drug or alcohol abuse within past 2 years
* Participation in any previous trial on aliskiren or other renin inhibitor
* Previous treatment with fish oil, steroid, cytotoxic agents, or aldosterone antagonist
* History of treatment with other drugs that may affect proteinuria within past 2 years
* Patients receiving treatment of corticosteroid
* On other investigational drugs within last 30 days
* History of a psychological illness or condition such as to interfere with the patient's ability to understand the requirement of the study
* History of non-compliance
* Known history of sensitivity or allergy to aliskiren or other renin inhibitor
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00870493
Study Brief:
Protocol Section:
NCT00870493