Cystine Capacity Clinical Study (CysCap)
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|ClinicalTrials.gov Identifier: NCT02120105|
Recruitment Status : Completed
First Posted : April 22, 2014
Last Update Posted : December 3, 2018
|Condition or disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||30 participants|
|Official Title:||Cystine Capacity Clinical Study (CysCap)|
|Actual Study Start Date :||September 2012|
|Actual Primary Completion Date :||February 24, 2017|
|Actual Study Completion Date :||February 24, 2017|
- Cystine capacity will be correlated with recurrence or non-recurrence of stones [ Time Frame: every 6 months over 3 years ]
The primary end point will be cystine capacity in participants who do and do not have recurrence of stones seen on radiologic imaging in the ipsilateral kidney which was rendered stone-free prior to enrollment.
Subjects who are enrolled in the study will perform semi-annual 24-hour urine collections for measurement of cystine capacity. 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.
- 24-hour urine cystine excretion [ Time Frame: every 6 months over 3 years ]We will compare 24 hour urine cystine excretion in patients who remain stone free and those who experience stone recurrence.
- episodes of renal colic and/or stone passage from a kidney that was previously stone-free [ Time Frame: every 6 months over 3 years ]Assessed by renal imaging, either ultrasound or CT scan, every 6 months.
- Evidence of new asymptomatic stones noted on the contralateral kidney [ Time Frame: every 6 months over 3 year observational study ]Cystine capacity will be compared in participants with or without recurrence of stones in the contralateral kidney by renal ultrasound or CT scan
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02120105
|United States, New York|
|NYU Langone Medical Center|
|New York, New York, United States, 10016|
|Principal Investigator:||David S Goldfarb, MD||NYU Langone Health|