Cystine Capacity Clinical Study (CysCap)

NCT02120105 | Completed

• 1 other identifier: 6402
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystinuria

Keywords

Renal aminoaciduria; cystinuria; D-penicillamine; renal tubular transport; inborn errors; tiopronin; urolithiasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 24-hour urine cystine excretion

  every 6 months over 3 years

• episodes of renal colic and/or stone passage from a kidney that was previously stone-free

  every 6 months over 3 years

• Evidence of new asymptomatic stones noted on the contralateral kidney

  every 6 months over 3 year observational study

Study Arms (1)

Cystinuria

Eligibility Criteria

• Age: 8 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

For patients to be enrolled in this study they must have a diagnosis of cystinuria.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Medical Center

New York, New York, 10016, United States

Location

Related Publications (1)

• Goldfarb DS, Coe FL, Asplin JR. Urinary cystine excretion and capacity in patients with cystinuria. Kidney Int. 2006 Mar;69(6):1041-7. doi: 10.1038/sj.ki.5000104.

  PMID: 16501494 BACKGROUND

Related Links

• Rare Kidney Stone Consortium

MeSH Terms

Conditions

Cystinuria; Renal Aminoacidurias; Urolithiasis

Condition Hierarchy (Ancestors)

Renal Tubular Transport, Inborn Errors; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• David S Goldfarb, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2013
• First Posted: April 22, 2014
• Study Start: September 1, 2012
• Primary Completion: February 24, 2017
• Study Completion: February 24, 2017
• Last Updated: December 3, 2018

Record last verified: 2018-11

Locations

US (1)