Cystinuria Clinical Trial
Official title:
Cystine Capacity Clinical Study (CysCap)
The purpose of this study is to determine whether urinary cystine capacity, an assay used to measure the amount of cystine in the urine, can be used to predict stone recurrence in patients with cystinuria.
Cystinuria is a rare genetic cause of kidney stones that leads to significant morbidity due
to the recurrent nature of the disease. Despite recent advancements in knowledge about
cystinuria, such as the discovery of the genetic defects that cause the disease, there have
been very few studies of clinical determinants of recurrent stone formation. An optimal
method of measuring cystine solubility in the urine has been lacking, and therefore response
to pharmacologic and dietary therapy is often not known. Recently, a new assay to measure the
amount of cystine in the urine was developed called Cystine Capacity, or CysCap. It is an
assay that adds a pre-formed amount of cystine crystals to urine and measures the amount of
cystine the urine can take up from the solid phase (in undersaturated urine) or gives up to
solid phase (in supersaturated urine). This study seeks to examine how well this measure of
urinary cystine predicts stone occurrence, with the ultimate goal of helping to guide therapy
and preventing kidney stones in cystinurics.
This is an observational study over 3 years. Subjects who are enrolled in the study will
perform semi-annual 24-hour urine collections. They will undergo imaging of the kidneys every
6 months to monitor kidney stone formation or growth, in order to correlate urinary
parameters with clinical events. The study will examine how well the urinary cystine capacity
predicts stone formation.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02538016 -
TCUPS- Tolvaptan Use in Cystinuria and Urolithiasis: A Pilot Study
|
N/A | |
| Recruiting |
NCT06065852 -
National Registry of Rare Kidney Diseases
|
||
| Recruiting |
NCT00169806 -
Randall's Plaque Study: Pathogenesis and Relationship to Nephrolithiasis
|
N/A | |
| Completed |
NCT03663855 -
Effect of Increasing Doses of Tiopronin on Cystine Capacity in Patients With Cystinuria
|
Phase 2 | |
| Recruiting |
NCT02780297 -
Prospective Research Rare Kidney Stones (ProRKS)
|
||
| Recruiting |
NCT02026388 -
Rare Kidney Stone Consortium Biobank
|
||
| Recruiting |
NCT04818034 -
The Effect of Sodium-glucose Cotransporter (SGLT) 2 Inhibitors on Cystine Stone Formation: A Preliminary Study
|
Phase 2 | |
| Withdrawn |
NCT04137978 -
Study Evaluating Patients With Cystinuria
|
Phase 2/Phase 3 | |
| Recruiting |
NCT02942420 -
Bucillamine Phase 2 Trial in Patients With Cystinuria
|
Phase 2 | |
| Completed |
NCT05048563 -
Registry of Thiola EC Therapy
|
||
| Not yet recruiting |
NCT04147871 -
Study Evaluating Patients With Cystinuria and Efficacy and Safety Exploratory Study in the Youngest Children
|
Phase 2/Phase 3 | |
| Completed |
NCT02125721 -
Effect of Increasing Doses of Cystine Binding Thiol Drugs on Cystine Capacity in Patients With Cystinuria
|
Phase 4 | |
| Active, not recruiting |
NCT02910531 -
Lipoic Acid Supplement for Cystine Stone
|
Phase 2 | |
| Recruiting |
NCT00588562 -
Rare Kidney Stone Consortium Patient Registry
|
||
| Completed |
NCT02124395 -
Health-related Quality of Life in Rare Kidney Stone
|
||
| Not yet recruiting |
NCT05058859 -
Long Term Clinical Efficacy of Sodium-glucose Cotransporter-2 (SGLT-2) Inhibitor in Cystinurics
|
Phase 2 | |
| Active, not recruiting |
NCT03539926 -
This Study Evaluates the Superiority of Daily Self-pH Monitorization of Lit-control®pH Meter Compared to the Monitorization of Reactive Strips (Standard of Care).
|
N/A | |
| Completed |
NCT00381849 -
Use of an Herbal Preparation to Prevent and Dissolve Kidney Stones
|
Phase 1/Phase 2 | |
| Completed |
NCT03836144 -
Effect of Urine Alkalinazation on Urinary Inflammatory Markers in Patients With Cystinuria
|