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 @ 7:00 PM
Ignite Modification Date:
2025-12-24 @ 7:00 PM
NCT ID:
NCT00309257
Eligibility Criteria:
Inclusion Criteria:
* age ≥15 years
* Alport disease
* Creatinine clearance \>20 ml/min/1.73 mq with variation of less than 30% in the three months prior to study entry
* written informed consent. For patients \<18 years old a written informed consent of both parents is needed
Exclusion Criteria:
* treatment with immunosuppressive drugs in the six months preceding the study
* vascular disease of the kidney
* obstructive uropathy, prostatic hypertrophy, incomplete bladder emptying
* transplanted kidney
* clinically relevant electrolyte imbalance (e.g., hyperkaliemia with serum K+ \> 5.5 mEq/l)
* any concomitant medication with drugs that may directly affect UAE including ACE-inhibitors, angiotensin II receptor antagonists, non dihydropyridine CCBS, HMGCoA reductase inhibitors in the last one month
* history of hypersensitivity to the study drugs
* impossibility to temporary withdrawn ACE-I or ATA II or statins (heart failure, cardiovascular events over the last three months)
* any clinically relevant condition that may affect study participation and/or study results
* pregnancy, ineffective contraception, breast feeding
* inability to fully understand the purposes/risks of the study and/or to provide a written informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Years
Maximum Age:
70 Years
Study:
NCT00309257
Study Brief:
Protocol Section:
NCT00309257