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COMPLETEDPhase 2NCT03663855

Effect of Increasing Doses of Tiopronin on Cystine Capacity in Patients With Cystinuria

The purpose of this study is to determine the minimum effective dose of the cysteine binding thiol drug (CBTD) Tiopronin on urine cystine capacity, which is a measure of cystine solubility in the urin...

Lead sponsor: NYU Langone Health•1 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

NYU Langone Health

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Patients with a confirmed laboratory diagnosis of cystinuria who meet the following criteria: (1) stone analysis demonstrating cystine as a component, or (2) increased urinary cystine excretion (\>250mg/24hrs in adults).
•A medical regimen that includes Tiopronin.
•Willing to use a medically accepted form of birth control, if female and of child bearing- potential
•Ability to reliably urinate in a collection vessel and measure urine volume.
•Ability to give informed consent.
•Documentation of a stable complete blood count (CBC) and urinalysis (UA) in the six month period prior to the date of enrollment.
•Enrollment in Rare Kidney Stone Consortium (RKSC) Protocol 6401 (Cystinuria Registry)

Exclusion Criteria

•Women who are pregnant, breastfeeding, or trying to become pregnant
•Patients with renal colic
•Patients who are scheduled to undergo a surgical procedure
•Inability to give informed consent

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: December 17, 2021Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE2

Enrollment10

Start dateNov 2018

Last updatedDec 17, 2021

Condition

Locations shown

New York University School of Medicine

New York, New York

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 17, 2021Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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