Alpha Lipoic Acid for Cystinuria

(ALA Trial)

Overseen By Victoria Hogue, MA

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of California, San Francisco

Must not be taking: Alpha-lipoic acid

Disqualifiers: Diabetes, Pregnancy, Serious illness, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 3 years

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study evaluates how daily alpha lipoic acid supplementation affects cystine kidney stone recurrence. Half of the subjects will receive 1200 mg alpha lipoic acid orally daily for three years, while the other half will receive a placebo. The funding source for this clinical trial is FDA OOPD.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are currently taking alpha-lipoic acid, you would need to stop, as the trial excludes those who have taken it within the last year.

Is alpha-lipoic acid safe for humans?

Alpha-lipoic acid is generally safe for adults, as shown in a review of 71 clinical studies with no increased risk of adverse events. However, there have been rare cases of toxicity, especially in children and adolescents, with one fatal case reported after a large overdose. ^{1 2 3 4 5}

How does the drug alpha-lipoic acid differ from other treatments for cystinuria?

Alpha-lipoic acid is unique because it acts as a powerful antioxidant, which may help protect the kidneys from damage. This is different from other treatments for cystinuria that primarily focus on reducing cystine levels in the urine. Its potential to minimize oxidative stress could offer a novel approach to managing kidney-related complications in cystinuria. ^{6 7 8 9 10}

What evidence supports the effectiveness of the drug alpha-lipoic acid for treating cystinuria?

Alpha-lipoic acid has shown potential in reducing oxidative stress and improving kidney function in conditions like obstructive nephropathy and experimental renal lithiasis, which involve similar mechanisms to cystinuria. Its antioxidant properties may help protect the kidneys and prevent stone formation. ^{1 10 11 12 13}

Who Is on the Research Team?

Thomas Chi, M.D.

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have had cystine kidney stones in the past.

Being able and willing to provide consent

You have been diagnosed with cystinuria based on a urine test or analysis of kidney stones.

Exclusion Criteria

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

I have taken alpha-lipoic acid in the past year.

Pregnancy, lactation, or child-bearing age without birth control devices

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either 1200 mg alpha lipoic acid or placebo daily for three years

3 years

Routine clinical visit every 4 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Alpha lipoic acid
• Placebo

Trial Overview 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.

How Is the Trial Designed?

Group I: ALA supplement Experimental Treatment 1 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: Placebo Placebo Group 1 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.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Thomas Chi, MD

Lead Sponsor

Trials

1

Recruited

50+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Citations

1. England pubmed.ncbi.nlm.nih.gov

Mitigation of free radical toxicity in hyperoxaluric condition by a novel derivative eicosapentaenoate-lipoate. [2017]

2. United States pubmed.ncbi.nlm.nih.gov

Alpha-lipoic acid attenuates renal injury in rats with obstructive nephropathy. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Alpha-lipoic acid in liver metabolism and disease. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Oxidative stress in 5/6 nephrectomized rat model: effect of alpha-lipoic acid. [2013]

5. Australia pubmed.ncbi.nlm.nih.gov

Tissue lipids in experimental calcium oxalate lithiasis and the effect of DL alpha-lipoic acid. [2013]

6. United States pubmed.ncbi.nlm.nih.gov

Alpha Lipoic Acid Toxicity: The First Reported Mortality in an Adult Patient After Multiorgan Failure. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Safety Evaluation of α-Lipoic Acid Supplementation: A Systematic Review and Meta-Analysis of Randomized Placebo-Controlled Clinical Studies. [2020]

8. Turkey pubmed.ncbi.nlm.nih.gov

Alpha-lipoic acid intoxication in an adolescent girl: Case report and review of the literature. [2021]

9. Germany pubmed.ncbi.nlm.nih.gov

Fatal non-accidental alpha-lipoic acid intoxication in an adolescent girl. [2014]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Beneficial effect of DL-alpha-lipoic acid on cyclosporine A induced hyperlipidemic nephropathy in rats. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Plasma kinetics, metabolism, and urinary excretion of alpha-lipoic acid following oral administration in healthy volunteers. [2013]

12. Netherlands pubmed.ncbi.nlm.nih.gov

High-performance liquid chromatographic assay for alpha-lipoic acid and five of its metabolites in human plasma and urine. [2019]

13. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Long-term effect of 3-week intravenous alpha-lipoic acid administration in symptomatic diabetic polyneutropathy with clinical manifestations]. [2013]