Cystinuria Clinical Trial
Official title:
Cystine Capacity Clinical Study (CysCap)
NCT number | NCT02120105 |
Other study ID # | 6402 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | September 2012 |
Est. completion date | February 24, 2017 |
Verified date | November 2018 |
Source | New York University School of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | February 24, 2017 |
Est. primary completion date | February 24, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 8 Years to 80 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | NYU Langone Medical Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
New York University School of Medicine |
United States,
Goldfarb DS, Coe FL, Asplin JR. Urinary cystine excretion and capacity in patients with cystinuria. Kidney Int. 2006 Mar;69(6):1041-7. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cystine capacity will be correlated with recurrence or non-recurrence of stones | 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. |
every 6 months over 3 years | |
Secondary | 24-hour urine cystine excretion | We will compare 24 hour urine cystine excretion in patients who remain stone free and those who experience stone recurrence. | every 6 months over 3 years | |
Secondary | episodes of renal colic and/or stone passage from a kidney that was previously stone-free | Assessed by renal imaging, either ultrasound or CT scan, every 6 months. | every 6 months over 3 years | |
Secondary | Evidence of new asymptomatic stones noted on the contralateral kidney | Cystine capacity will be compared in participants with or without recurrence of stones in the contralateral kidney by renal ultrasound or CT scan | every 6 months over 3 year observational study |
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