LLX-424 for Kidney Stones

Recruiting at 2 trial locations

Overseen By Clinical Operations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Lilac Therapeutics, Inc.

Disqualifiers: Unstable kidney function, Kidney transplant, Cirrhosis, others

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

Compensation: Varies

Number of Visits: 1

Duration: 8 weeks

51 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

How does the drug LLX-424 for kidney stones differ from other treatments?

LLX-424 may be unique in its approach to treating kidney stones by potentially increasing urinary citrate and pH, similar to potassium citrate, which helps reduce calcium oxalate crystal formation. This could make it different from other treatments that do not focus on altering urine composition to prevent stone formation. ^{1 2 3 4 5}

What is the purpose of this trial?

This is a Phase 2a study of glycolate oxidase inhibitor LLX-424 in patients with a history of kidney stones. Eligible subjects with a history of kidney stones will be randomized to receive study drug (LLX-424 or placebo) for 8 weeks.

Eligibility Criteria

This trial is for people who have had kidney stones before. Participants will be randomly assigned to receive either the study drug LLX-424 or a placebo for 8 weeks.

Inclusion Criteria

History of kidney stones documented in medical records

24-hour urine oxalate excretion

Body mass index 18.5 to 38 kg/m2 inclusive

Exclusion Criteria

I have had a kidney transplant.

History or medical record evidence of kidney stones that are not calcium oxalate

Spot urine protein to creatinine ratio ≥ 1 mg/mg at screening

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive LLX-424 or placebo for 8 weeks

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

1 visit (outpatient)

Treatment Details

Interventions

• LLX-424

Trial Overview The trial is testing LLX-424, which is a glycolate oxidase inhibitor, to see if it can help prevent the formation of kidney stones in patients with a history of this condition.

Participant Groups

Group I: LLX-424 Experimental Treatment 1 Intervention

Tablets for oral administration

Group II: Placebo Placebo Group 1 Intervention

Tablets for oral administration

Who Is Running the Clinical Trial?

Lilac Therapeutics, Inc.

Lead Sponsor

Findings from Research

Lemonade therapy (LT) alone significantly increased urinary citrate and total urine volume in patients with calcium oxalate stone formation, with a maximum increase of 203 mg/day in urinary citrate and 763 mL/day in urine volume.

When combined with potassium citrate, LT was even more effective, resulting in a greater increase in urinary citrate (346 mg/day) and total urine volume (860 mL/day), highlighting the potential for enhanced treatment strategies for preventing stone formation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lemonade therapy increases urinary citrate and urine volumes in patients with recurrent calcium oxalate stone formation. Penniston, KL., Steele, TH., Nakada, SY.[2013]

In a study involving five calcium oxalate stone formers, the ingestion of minimum doses of potassium citrate significantly increased citraturia and crystallization inhibitory capacity in urine samples.

The most effective timing for taking potassium citrate was after dinner, suggesting that this method could help reduce the risk of kidney stone formation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronopharmacological studies on potassium citrate treatment of oxalocalcic urolithiasis. Grases, F., Conte, A., March, JG., et al.[2019]

References

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

Lemonade therapy increases urinary citrate and urine volumes in patients with recurrent calcium oxalate stone formation. [2013]

2. Italy pubmed.ncbi.nlm.nih.gov

Oxalate and calcium oxalate crystals are injurious to renal epithelial cells: results of in vivo and in vitro studies. [2013]

3. Germany pubmed.ncbi.nlm.nih.gov

A single center comparative study of two single use digital flexible ureteroscopy in the management of renal stones less than 2 cm. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

In vitro anti-lithogenic activity of lime powder regimen (LPR) and the effect of LPR on urinary risk factors for kidney stone formation in healthy volunteers. [2018]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Chronopharmacological studies on potassium citrate treatment of oxalocalcic urolithiasis. [2019]