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Antioxidant

Alpha Lipoic Acid for Cystinuria (ALA Trial)

Phase 2

Waitlist Available

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

History of previous cystine kidney stones

Be older than 18 years old

Must not have

Poorly controlled diabetes mellitus (hemoglobin A1C > 8.0% for more than 1 year)

Non-English primary language

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Summary

This trial will study whether taking alpha lipoic acid everyday can prevent kidney stones from coming back.

Who is the study for?

This trial is for people with cystinuria who've had kidney stones made of cystine. They must have documented evidence of the condition, be willing to consent, and not be pregnant or planning pregnancy during the study. It's not for those with uncontrolled diabetes, current alpha-lipoic acid use, non-English speakers, prisoners, or anyone seriously ill.

What is being tested?

The trial tests if taking a daily dose of 1200 mg alpha lipoic acid can prevent cystine kidney stone recurrence over three years compared to a placebo (a pill without active medication). Participants are randomly assigned to one of these two groups.

What are the potential side effects?

Alpha lipoic acid may cause side effects like skin rashes, cramps in the abdomen area, nausea or vomiting. Since it's an antioxidant supplement generally considered safe at recommended doses; however individual reactions can vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had cystine kidney stones in the past.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My diabetes has not been well-managed for over a year.

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My primary language is not English.

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I am unable to understand and agree to the study's procedures and risks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cystine stone recurrence

Secondary study objectives

Urinary cystine level

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ALA supplementExperimental Treatment1 Intervention

Clinical data including medical history, plain KUB x-ray and renal ultrasound, routine blood work and 24-hour urine collections for all subjects will be collected as part of normal clinical care at routine clinical visit every 4 months. Subjects in this study arm will be taking one supplement tablet containing 1200 mg of alpha lipoic acid orally once daily for three years. At the end of the three years of study drug treatment, all subjects will undergo a low dose non-contrast CT scan to look for a silent change in stone size.

Group II: PlaceboPlacebo Group1 Intervention

Clinical data including medical history, plain KUB x-ray and renal ultrasound, routine blood work and 24-hour urine collections for all subjects will be collected as part of normal clinical care at routine clinical visit every 4 months. Subjects in this study arm will be taking one placebo tablet containing 10 mg of sucrose orally once daily for three years. At the end of the three years of study drug treatment, all subjects will undergo a low dose non-contrast CT scan to look for a silent change in stone size.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Alpha lipoic acid

2022

Completed Phase 4

~890

0 / 4Eligibility criteria met