A Study to Evaluate Homocysteine Metabolism and Endothelial Function in ADPKD (NCT05193981) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
A Study to Evaluate Homocysteine Metabolism and Endothelial Function in ADPKD
United States80 participantsStarted 2021-09-14
Plain-language summary
The purpose of this study is to assess homocysteine metabolism and systemic endothelial function at the early stages of the disease and determine the prognostic value of homocysteine, related metabolites, and markers of endothelial function and injury to estimate renal disease severity and progression in patients with early Autosomal Dominant Polycystic Kidney Disease (ADPKD).
Who can participate
Age range
15 Years – 40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male and Female subjects, 15-40 years of age, inclusive
* Previous diagnosis of ADPKD (Based on Ravine et al. criteria)
* Class 1 according to imaging classification
* Estimated GFR\>70 mL/min/1.73m\^2(CKD-EPI)
* Ability to provide written, informed consent.
Exclusion Criteria:
* Class 2 according to imaging classification
* A concomitant systemic disease affecting the kidney
* Diabetes mellitus
* Predicted urine protein excretion in urinalysis \>1 g/24 hrs
* Subjects having contraindications to or interference with MRI assessments
* Patients that are part of an interventional study or taking tolvaptan
* Female subjects that are pregnant
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in height adjusted Total kidney volume (htTKV)
Timeframe: Baseline to 24 months
2
Baseline endothelial function, homocysteine and related metabolite levels as predictors of change in TKV