Lipoic Acid Supplement for Cystine Stone

Status Active, not recruiting

Clinical Trial Summary

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.

Clinical Trial Description

Cystinuria is a rare inherited autosomal recessive disorder of the kidney that is the result of a defect in the dibasic amino acid transporter in the renal proximal tubule and small intestine. Supersaturation of cystine in the urine produces crystals that precipitate and form calculi, which can be a cause of obstruction, infection, and chronic kidney disease (Chillarón 2010). One potential therapeutic is a thiol-containing compound alpha-lipoic acid (thioctic acid, 5-(1,2-dithiolan-3- yl) pentanoic acid, ALA). It is an over-the-counter supplement with antioxidant property. Once ALA is transported into the cell, it is reduced to dihydrolipoic acid (DHLA). Both ALA and DHLA have direct antioxidant activity (Scholich 1989), and they can regenerate endogenous antioxidants including ascorbic acid and vitamin E. It can also increase intracellular coenzyme Q10 and glutathione levels. ALA and DHLA also have additional biochemical effects as metal chelators, reactive oxygen species scavengers, and modulators of signaling transduction of several pathways (Gomes 2014). While the potential therapeutic effects of ALA have been studied in a number of diseases including, for example, Alzheimer's disease, obesity, cardiovascular disease, hypertension, and several cancers (Gomes 2014), the efficacy of ALA has been best studied in type 2 diabetic peripheral neuropathy (Ziegler 2011). In our lab, results from a mouse model of cystinuria show that ALA markedly slows the initiation of cystine stone formation as well as the growth of existing stones. Given this history in clinical medicine and, most importantly, based upon our positive findings of ALA effectiveness in a mouse model of cystinuria, we propose a pilot study on the use of this molecule in cystinuric patients. ;

Study Design

Related Conditions & MeSH terms

Cystinuria

Clinical Trial Details

NCT number	NCT02910531
Study type	Interventional
Source	University of California, San Francisco
Contact
Status	Active, not recruiting
Phase	Phase 2
Start date	June 19, 2017
Completion date	June 2025

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See also
Status	Clinical Trial	Phase
Completed	`NCT02120105` - Cystine Capacity Clinical Study (CysCap)
Completed	`NCT02538016` - TCUPS- Tolvaptan Use in Cystinuria and Urolithiasis: A Pilot Study	N/A
Recruiting	`NCT06065852` - National Registry of Rare Kidney Diseases
Recruiting	`NCT00169806` - Randall's Plaque Study: Pathogenesis and Relationship to Nephrolithiasis	N/A
Completed	`NCT03663855` - Effect of Increasing Doses of Tiopronin on Cystine Capacity in Patients With Cystinuria	Phase 2
Recruiting	`NCT02780297` - Prospective Research Rare Kidney Stones (ProRKS)
Recruiting	`NCT02026388` - Rare Kidney Stone Consortium Biobank
Recruiting	`NCT04818034` - The Effect of Sodium-glucose Cotransporter (SGLT) 2 Inhibitors on Cystine Stone Formation: A Preliminary Study	Phase 2
Withdrawn	`NCT04137978` - Study Evaluating Patients With Cystinuria	Phase 2/Phase 3
Recruiting	`NCT02942420` - Bucillamine Phase 2 Trial in Patients With Cystinuria	Phase 2
Completed	`NCT05048563` - Registry of Thiola EC Therapy
Not yet recruiting	`NCT04147871` - Study Evaluating Patients With Cystinuria and Efficacy and Safety Exploratory Study in the Youngest Children	Phase 2/Phase 3
Completed	`NCT02125721` - Effect of Increasing Doses of Cystine Binding Thiol Drugs on Cystine Capacity in Patients With Cystinuria	Phase 4
Recruiting	`NCT00588562` - Rare Kidney Stone Consortium Patient Registry
Completed	`NCT02124395` - Health-related Quality of Life in Rare Kidney Stone
Not yet recruiting	`NCT05058859` - Long Term Clinical Efficacy of Sodium-glucose Cotransporter-2 (SGLT-2) Inhibitor in Cystinurics	Phase 2
Active, not recruiting	`NCT03539926` - This Study Evaluates the Superiority of Daily Self-pH Monitorization of Lit-control®pH Meter Compared to the Monitorization of Reactive Strips (Standard of Care).	N/A
Completed	`NCT00381849` - Use of an Herbal Preparation to Prevent and Dissolve Kidney Stones	Phase 1/Phase 2
Completed	`NCT03836144` - Effect of Urine Alkalinazation on Urinary Inflammatory Markers in Patients With Cystinuria

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Lipoic Acid Supplement for Cystine Stone — ALA

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms