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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
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:
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.

Condition or disease
Cystinuria

Detailed Description:

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.

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort
Cystinuria



Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
For patients to be enrolled in this study they must have a diagnosis of cystinuria.
Criteria

Inclusion Criteria:

  • Patients with a confirmed laboratory diagnosis of cystinuria will be included in this study. There will be no age barrier to inclusion, but included patients must be able to reliably collect urine for 24 hours. Men and women will be recruited equally and there are no restrictions for racial or ethnic origin in this study.
  • Patient enrollment will require signing of an informed consent document approved by the Lenox Hill IRB.
  • For children 8-18 years of age, signing an assent to participate will also be required.

Exclusion Criteria:

  • Patients will be excluded if they cannot sign consent or assent.
  • Furthermore if the patient cannot reliably collect urine for 24 hours or adhere to study follow up visit requirements.

Information from the National Library of Medicine

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


Locations
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United States, New York
NYU Langone Medical Center
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: David S Goldfarb, MD NYU Langone Health
Additional Information:
Publications:
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT02120105    
Other Study ID Numbers: 6402
First Posted: April 22, 2014    Key Record Dates
Last Update Posted: December 3, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NYU Langone Health:
Renal aminoaciduria
cystinuria
D-penicillamine
renal tubular transport
inborn errors
tiopronin
urolithiasis
Additional relevant MeSH terms:
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Cystinuria
Renal Aminoacidurias
Renal Tubular Transport, Inborn Errors
Kidney Diseases
Urologic Diseases
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases