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Dietary Modification

Prevention Strategies for Kidney Stones

Phase 4
Recruiting
Led By Ryan Hsi, MD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adult
Two or more symptomatic kidney stone events in the last 5 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline compared to two months
Awards & highlights

Study Summary

This trial will compare the effects of two different treatment strategies for kidney stones. The first approach is to give medication to everyone at risk, while the second is to only give medication to those who have already developed stones.

Who is the study for?
This trial is for adults who've had two or more painful kidney stone episodes in the past five years. It's not suitable for those with certain kidney conditions, untreated urinary blockages, specific metabolic disorders, pregnancy, inflammatory bowel disease or related surgeries, sarcoidosis, cystinuria, severe chronic kidney disease (eGFR<60), frequent gout attacks, allergies to study meds or imbalances in blood potassium/sodium.Check my eligibility
What is being tested?
The study compares two approaches to prevent new kidney stones: 'Selective Therapy' which tailors diet and drugs to individual needs versus 'Empiric Therapy' that uses a general diet and medication plan. Participants are randomly assigned to one of these strategies.See study design
What are the potential side effects?
Potential side effects from the treatments could include digestive issues due to dietary changes and reactions like rashes or other symptoms from medications. Adherence difficulty and any organ-specific impacts will also be monitored as adverse effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
I have had two or more painful kidney stone episodes in the past 5 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 2 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 2 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Calcium oxalate supersaturation
Calcium phosphate supersaturation
Secondary outcome measures
24hr urine parameters
Uric acid supersaturation
Other outcome measures
24hr urine parameters from baseline to month 1
24hr urine parameters from month 1 to month 2
Adverse events
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Selective TherapyExperimental Treatment2 Interventions
Diet intervention and drug intervention based on 24 hour urine results
Group II: Empiric TherapyActive Control2 Interventions
Diet intervention and drug intervention not based on 24 hour urine results

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
853 Previous Clinical Trials
671,012 Total Patients Enrolled
3 Trials studying Kidney Stones
213 Patients Enrolled for Kidney Stones
Ryan Hsi, MDPrincipal InvestigatorVanderbilt University Medical Center
2 Previous Clinical Trials
280 Total Patients Enrolled
1 Trials studying Kidney Stones
80 Patients Enrolled for Kidney Stones

Media Library

Empiric Therapy: Diet (Dietary Modification) Clinical Trial Eligibility Overview. Trial Name: NCT05365477 — Phase 4
Kidney Stones Research Study Groups: Selective Therapy, Empiric Therapy
Kidney Stones Clinical Trial 2023: Empiric Therapy: Diet Highlights & Side Effects. Trial Name: NCT05365477 — Phase 4
Empiric Therapy: Diet (Dietary Modification) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05365477 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this clinical trial currently open?

"Affirmative. Details from clinicaltrials.gov suggest that this trial is still enrolling candidates, having initially been announced on the 4th of August 2022 and last updated the same day. 56 people have to be recruited from 1 medical centre for it to succeed"

Answered by AI

Has the FDA officially sanctioned Selective Therapy: Drug?

"Due to Selective Therapy: Drug's status as a Phase 4 trial, our team gave it an overall safety rating of 3; this medication has been officially approved for use."

Answered by AI

What is the total number of individuals participating in this experiment?

"Affirmative. According to information on clinicaltrials.gov, this research study is actively recruiting subjects after being first published on August 4th 2022 and last updated the same day. A total of 56 individuals across one site must be enrolled for successful completion of the trial."

Answered by AI
~22 spots leftby Mar 2025