Phase 4
Completed N=10
Effect of Increasing Doses of Cystine Binding Thiol Drugs on Cystine Capacity in Patients With Cystinuria
Cystinuria
Source: ClinicalTrials.gov NCT02125721 ↗
Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcomePrimary: Cystine Capacity — 43.1 mg/L
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cystine Capacity |
43.1 | — |
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.
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. Informational only — not medical advice.