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 @ 2:28 AM
Ignite Modification Date:
2025-12-25 @ 2:28 AM
NCT ID:
NCT06931834
Eligibility Criteria:
Inclusion Criteria
A patient must meet all of the following criteria to be eligible:
1. Age 18 to 75 years inclusive;
2. Diagnosis of genetically-confirmed mitochondrial disease with a pathogenic mutation or defect in their mitochondrial or nuclear DNA;
3. Diagnosis of chronic kidney disease stage 3 or stage 4;
4. Moderate or severe symptomatology of mitochondrial disease;
5. A sexually-active patient agrees to practice acceptable methods of contraception throughout the protocol period;
6. The patient is not eligible for, or does not have access to, a clinical trial;
7. The patient (or guardian/legal representative) provides signed and dated informed consent to be treated with probucol in accordance with the expanded access protocol.
Exclusion Criteria
A patient who meets any of the following criteria will not be eligible:
1. A known hypersensitivity or adverse reaction to probucol;
2. A medical condition or laboratory result that, in the opinion of the treating physician, will interfere with the safe completion of the protocol;
3. An active fungal infection, acute blood, lung, or bladder infection, clinically significant hepatic or renal dysfunction, and/or viral infection (past or present) that, in the opinion of the treating physician, may have a clinically significant effect on their treatment;
4. Taking an investigational drug other than probucol within one month prior to the first dosing with probucol under the protocol;
5. A medical history or condition that increases the potential for QTc prolongation;
6. A female with a positive pregnancy test result or who is breastfeeding;
7. Has received or is receiving kidney dialysis;
8. Has received or is scheduled to receive an organ transplant;
9. Known or suspected active alcohol and/or substance abuse;
10. A history of or current suicidal ideation, behavior, and/or attempts; or
11. Is unable to swallow tablets or requires gastric feeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06931834
Study Brief:
Protocol Section:
NCT06931834