Selective Therapy: Drug for Kidney Stones

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Vanderbilt University Medical Center, Nashville, TN
Kidney Stones+2 More
Selective Therapy: Drug - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The aims of this study are to 1) Conduct a randomized clinical trial of selective versus empiric diet plus pharmacologic therapy in high-risk stone formers and 2) Determine adverse effects from, and adherence to selective and empiric strategies.

Eligible Conditions

  • Kidney Stones
  • Nephrolithiasis

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Other trials for Kidney Stones

Study Objectives

2 Primary · 2 Secondary · Reporting Duration: Baseline compared to two months

Month 2
24hr urine parameters from month 1 to month 2
Baseline compared to two months
24hr urine parameters
Calcium oxalate supersaturation
Calcium phosphate supersaturation
Uric acid supersaturation
Baseline to 1 month
24hr urine parameters from baseline to month 1
Baseline to 2 months
Adverse events
Diet adherence
Diet and medication adherence
Kidney stone events
Medication adherence

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Kidney Stones

Trial Design

2 Treatment Groups

Empiric Therapy
1 of 2
Selective Therapy
1 of 2
Active Control
Experimental Treatment

56 Total Participants · 2 Treatment Groups

Primary Treatment: Selective Therapy: Drug · No Placebo Group · Phase 4

Selective TherapyExperimental Group · 2 Interventions: Selective Therapy: Diet, Selective Therapy: Drug · Intervention Types: Behavioral, Drug
Empiric TherapyActiveComparator Group · 2 Interventions: Empiric Therapy: Drug, Empiric Therapy: Diet · Intervention Types: Drug, Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline compared to two months
Closest Location: Vanderbilt University Medical Center · Nashville, TN
Photo of vanderbilt university medical center 1Photo of vanderbilt university medical center 2Photo of vanderbilt university medical center 3
2006First Recorded Clinical Trial
5 TrialsResearching Kidney Stones
1026 CompletedClinical Trials

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
758 Previous Clinical Trials
590,031 Total Patients Enrolled
3 Trials studying Kidney Stones
223 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

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have two or more symptomatic kidney stone events in the last 5 years.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.