Phase 4 N=10 Treatment

Effect of Increasing Doses of Cystine Binding Thiol Drugs on Cystine Capacity in Patients With Cystinuria

Cystinuria

Bottom Line

View on ClinicalTrials.gov: NCT02125721 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2021

Primary outcome: Primary: Cystine Capacity — 43.1 mg/L

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Tiopronin 1g per day (Drug); Tiopronin 2g per day (Drug); Tiopronin 3g per day (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: NYU Langone Health
Primary completion: Dec 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Cystine Capacity	43.1	—

Summary

The purpose of this study is to evaluate the effect of escalating doses of cystine biding thiol drugs, including tiopronin and d-penicillamine, on the urinary cystine capacity, which is a measure of the amount of cystine in the urine, in patients with cystinuria. The overall goal will be to help guide therapy and ultimately minimize unnecessary side effects caused by larger doses.

Eligibility Criteria

Inclusion Criteria

Be a patient with a confirmed diagnosis of cystinuria.
Be already taking a CBTD (either D-penicillamine (Cuprimine®) or tiopronin (Thiola®) as part of your medication regimen.
Be between 18 and 80 years of age
Be enrolled in the Cystinuria Registry.

Exclusion Criteria

You are not a patient with cystinuria
You are not already taking a cystine binding thiol drug
You have renal colic (if you are passing a stone)
You are scheduled to undergo a urologic procedure
You are unwilling or unable to provide informed consent in order to be able to participate.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02125721). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.