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 @ 2:32 AM
Ignite Modification Date:
2025-12-25 @ 2:32 AM
NCT ID:
NCT00600834
Eligibility Criteria:
Inclusion Criteria:
COHORT 1
* Is going to receive or has received PROHANCE injection during an MRI examination;
* Has CKD with eGFR stably comprised between 30 and 59 mL/min/1.73m2, as calculated from a SCr value obtained from the local laboratory within 24 hours prior to the PROHANCE injection.
* Provides written informed consent and is willing to comply with protocol requirements.
OR
COHORT 2
* Is going to receive or has received PROHANCE injection during an MRI examination;
* Has CKD with eGFR below 30 mL/min/1.73m2, as calculated from a SCr value obtained from the local laboratory within 24 hours prior to the PROHANCE injection.
* Provides written informed consent and is willing to comply with protocol requirements.
Exclusion Criteria:
COHORT 1
* Has received a GBCA within the past 12 months prior to inclusion in this study;
* Has unstable kidney function;
* Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data and achieving study objectives;
* Has ever been suspected of, or diagnosed with, NSF prior to the study-specific MRI;
* Is unable or unwilling to return for necessary office visits, to be examined by dermatologists or to undergo deep skin biopsy should development of NSF be suspected.
OR
COHORT 2
* Has received a GBCA within the past 12 months prior to inclusion in this study;
* Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data and achieving study objectives;
* Has ever been suspected of, or diagnosed with, NSF prior to the study-specific MRI;
* Is unable or unwilling to return for necessary office visits, to be examined by dermatologists or to undergo deep skin biopsy should development of NSF be suspected.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00600834
Study Brief:
Protocol Section:
NCT00600834