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 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT06794567
Eligibility Criteria:
Patients:
Inclusion Criteria:
1. A diagnosis of CKD warranting a referral to a nephrologist for further assessment AND
2. Screen positive for potential genetic kidney disease using the Ontario Health Provincial Genetics Program Eligibility Criteria for genetic assessment in CKD AND
3. Index participant or substitute decision maker (SDM) can provide informed consent to participate.
Exclusion Criteria:
1. Participant or SDM is unable to provide consent, for any reason, to be an unsuitable candidate for the study.
2. Fail screening as set out by the Provincial Genetics Program Eligibility Criteria for genetic assessment in CKD.
Family Members:
Inclusion Criteria:
1. Family/caregiver or SDM can provide informed consent to participate AND
2. Related patient participant must be enrolled in the study.
Exclusion Criteria:
1. Family/caregiver or SDM is unable to provide consent, for any reason, to be an unsuitable candidate for the study.
2. Related patient participant is not enrolled in the study.
Healthcare Provider:
Inclusion Criteria 1. Provided a referral for at least one study participant.
Exclusion Criteria:
1\. Is not a referring healthcare provider.
Qualitative Sub-Study:
Inclusion Criteria:
1. Patient participant who is enrolled in the main study.
2. 18 years or older.
3. The guardian for a minor
Exclusion Criteria:
1. \<18 years of age unless the guardian can conduct the interview
2. Patient participant who is not enrolled in the main study.
Healthy Volunteers:
True
Sex:
ALL
Study:
NCT06794567
Study Brief:
Protocol Section:
NCT06794567