Autosomal Dominant Polycystic Kidney Disease Clinical Trial
Official title:
Role of Homocysteine Metabolism, Endothelial Function and Microvascular Rarefaction on Renal Disease Severity and Progression in ADPKD
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).
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 among patients. Large phenotypic variability, incomplete understanding of underlying mechanisms, and lack of suitable biomarkers challenge potential therapies' identification, implementation, and evaluation. In ADPKD, systemic endothelial dysfunction (ED), characterized by an imbalance between vasodilating (particularly nitric oxide, NO) and vasoconstricting substances, develops early and correlates with renal disease severity. It has been previously associated with decreased NO availability, but NO abnormalities' mechanisms are still poorly understood. Endothelium-dependent, NO-mediated vasodilation is impaired in subjects with hyperhomocysteinemia, suggesting that NO availability is decreased in these subjects. Increased plasma levels of homocysteine have been reported in patients with ADPKD and preserved kidney function, likely contributing to a reduction in NO bioavailability. The mechanisms underlying increased homocysteine in ADPKD are not known. Furthermore, whether systemic endothelial function and injury or homocysteine levels can predict renal disease severity and progression in patients is unknown. The investigators' broad objective 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 ADPKD. Participants in this study will have a blood and a urine sample collected to determine biomarkers of oxidative stress, endothelial function and injury, homocysteine, and related metabolite levels. In addition, peripheral arterial tonometry (PAT) will determine systemic endothelial function, and an abdominal MRI will be performed to determine the patient's total kidney volume (TKV). ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02933268 -
High Water Intake in Polycystic Kidney Disease
|
N/A | |
| Completed |
NCT00759369 -
Water as Therapy in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
|
N/A | |
| Completed |
NCT00598377 -
Adrenal Functions in Autosomal Dominant Polycystic Kidney Disease
|
N/A | |
| Completed |
NCT01039987 -
Consortium for Radiologic Imaging Studies of Polycystic Kidney Disease
|
N/A | |
| Completed |
NCT03717883 -
ADPKD Alterations in Hepatic Transporter Function
|
||
| Completed |
NCT03487913 -
The ELiSA Study - Evaluation of Lixivaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease
|
Phase 2 | |
| Recruiting |
NCT05190744 -
PB to Treat Hereditary Nephrogenic Diabetes Insipidus, ADPKD Treated With Tolvaptan, and Severely Polyuric Patients With Previous Lithium Administration
|
Phase 2 | |
| Recruiting |
NCT05521191 -
A Study of RGLS8429 in Patients With Autosomal Dominant Polycystic Kidney Disease
|
Phase 1 | |
| Recruiting |
NCT04344769 -
Characterization of the Nrf2 Response in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD)
|
||
| Active, not recruiting |
NCT02848521 -
A Study Measuring Quality of Life, Treatment Preference and Satisfaction of ADPKD Patients in Europe
|
||
| Completed |
NCT01451827 -
8-Week Study of Tolvaptan Dose Forms in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
|
Phase 2 | |
| Completed |
NCT01210560 -
Dose-finding Study of New Tolvaptan Formulation in Subjects With ADPKD
|
Phase 2 | |
| Completed |
NCT01336972 -
Short-term Renal Hemodynamic Effects of Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD)
|
Phase 2 | |
| Completed |
NCT02134899 -
The Efficacy of Everolimus in Reducing Total Native Kidney Volume in Polycystic Kidney Disease Transplanted Recipients
|
Phase 3 | |
| Active, not recruiting |
NCT02729662 -
Efficacy of Tolvaptan on ADPKD Patients
|
N/A | |
| Recruiting |
NCT06065852 -
National Registry of Rare Kidney Diseases
|
||
| Recruiting |
NCT05288998 -
Intrarenal Microvasculature in ADPKD
|
||
| Recruiting |
NCT04939935 -
Implementation of Metformin theraPy to Ease Decline of Kidney Function in Polycystic Kidney Disease (IMPEDE-PKD)
|
Phase 3 | |
| Withdrawn |
NCT01988038 -
Repository Study of Autosomal Dominant Polycystic Kidney Disease
|
N/A | |
| Completed |
NCT01022424 -
A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) (2) [Extension of Study 156-05-002]
|
Phase 3 |