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 @ 4:04 AM
Ignite Modification Date:
2025-12-25 @ 4:04 AM
NCT ID:
NCT06642402
Eligibility Criteria:
SLE patients with kidney involvement
Inclusion criteria:
* \> 18 years old
* Fulfilling the 2019 EULAR/ACR classification criteria
* Positive autoantibodies, medical history and obejctive examination compatible with SLE
* Referred to kidney biopsy
Exclusion criteria:
* Lack of ability or willingness to provide informed consent
* Significant comorbidity, which is considered to potentially impact the outcome
SLE patients with no sign of kidney disease
Inclusion criteria:
* \> 18 years old
* Fulfilling the 2019 EULAR/ACR classification criteria
* Positive autoantibodies, medical history and obejctive examination compatible with SLE
* Normal plasma creatinine
* Urine albumine/creatinine \< 100 mg/g
Exclusion criteria:
* Lack of ability or willingness to provide informed consent
* Significant comorbidity, which is considered to potentially impact the outcome
Healthy controls:
Inclusion criteria:
* \> 18 years old
* No known kidney disease
Exclusion criteria:
* Lack of ability or willingness to provide informed consent
* Urine albumin-creatinine ratio \> 100 mg/g or proteinuria \> 100 mg/day
* Postive autoantibodies
* Significant comorbidity, which is considered to potentially impact the outcome
Biopsy control:
Inclusion criteria:
* \> 18 years old
* Negative autoantibiodies and immunoglobulines
* Referred to kidney biopsy
Exclusion criteria:
* Lack of ability or willingness to provide informed consent
* Significant comorbidity, which is considered to potentially impact the outcome
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06642402
Study Brief:
Protocol Section:
NCT06642402