Your session is about to expire
← Back to Search
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
ALA Trial 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.Check my eligibility
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.See study design
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.
ALA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had cystine kidney stones in the past.
ALA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cystine stone recurrence
Secondary outcome measures
Urinary cystine level
ALA 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
~790
Find a Location
Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,501 Previous Clinical Trials
15,236,521 Total Patients Enrolled
2 Trials studying Cystinuria
20 Patients Enrolled for Cystinuria
Thomas Chi, MDLead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,356 Previous Clinical Trials
4,315,016 Total Patients Enrolled
4 Trials studying Cystinuria
1,125 Patients Enrolled for Cystinuria
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My diabetes has not been well-managed for over a year.I have taken alpha-lipoic acid in the past year.You have a serious illness that is likely to cause death within the next 5 years.I have had cystine kidney stones in the past.My primary language is not English.You have been diagnosed with cystinuria based on a urine test or analysis of kidney stones.People who are in jail or prison.I am unable to understand and agree to the study's procedures and risks.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: ALA supplement
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Alpha lipoic acid received official sanction from the FDA?
"While Phase 2 trials don't have much data backing up their efficacy, there is at least some evidence suggesting that Alpha lipoic acid is safe. Therefore, it received a score of 2."
Answered by AI
Are new enrollees being accepted into this research project?
"The clinicaltrials.gov website says that this trial is not enrolling patients at the moment. The study was created on 6/19/2017 and last updated on 9/12/2022. There are, however, 4 other trials which are still recruiting patients."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger