Status:
ACTIVE_NOT_RECRUITING
A Study to Evaluate Homocysteine Metabolism and Endothelial Function in ADPKD
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Autosomal Dominant Polycystic Kidney Disease
Eligibility:
All Genders
15-40 years
Brief 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 metaboli...
Detailed Description
ADPKD is a devastating systemic disorder characterized by progressive development and enlargement of bilateral renal cysts, often leading to renal failure. Disease severity and progression vary widely...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 14 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05193981
Start Date
September 14 2021
End Date
June 1 2026
Last Update
April 11 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic
Rochester, Minnesota, United States, 55905