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 @ 2:19 AM
Ignite Modification Date:
2025-12-25 @ 2:19 AM
NCT ID:
NCT00035334
Eligibility Criteria:
PROTOCOL INCLUSION CRITERIA
* Patients must be 18 years of age or older.
* Males and females. If women of childbearing potential (i.e., not surgically sterilized or post-menopausal greater than one year) the patient must be using effective birth control.
* Diagnosis of AA amyloidosis demonstrated by positive biopsy (Congo red staining) and immunohistochemistry or immunoelectron microscopy at screening visit. Tissue from previous biopsy can be used for confirmation of diagnosis, if available.
* Persistent proteinuria defined as urinary protein excretion ? 1g/24h in two distinct 24-h urine collections at least 1 week apart within 3 months prior to study entry (baseline, Month 0 visit) without evidence of urinary tract infection or overt heart failure (NYHA class III or more); OR creatinine clearance ? 60 mL/min in two distinct measures at least 1 week apart within 3 months prior to study entry (baseline, Month 0 visit).
* Creatinine clearance ? 20 mL/min AND serum creatinine ? 3 mg/dl within 3 months prior to study entry (baseline, Month 0 visit).
* Written informed consent.
PROTOCOL EXCLUSION CRITERIA
* Evidence or suspicion of renal or renovascular diseases other than renal AA amyloidosis.
* Presence of diabetes mellitus (Type I and II).
* Evidence of a cause of potentially reversible reduced renal function, such as accelerated hypertension or drug nephrotoxicity.
* AST, ALT, or ALP \> 5 times the upper limit of normal, or total bilirubin 50% above upper limits of normal.
* Presence of any other clinically significant diseases that could interfere with the interpretation of study results or compromise patient safety or any conditions that could reduce life expectancy to less than two years.
* Use of an investigational drug within thirty days prior to the screening visit.
* Active alcohol and/or drug abuse.
* Initiation of or any changes in ACE inhibitor therapy within 3 months prior to the screening visit.
* Initiation of or any changes in cytotoxic agents/colchicine therapy within 3 months prior to the screening visit.
* Inability to provide legal consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00035334
Study Brief:
Protocol Section:
NCT00035334