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Placebo for Kidney Stones

Phase 2

Waitlist Available

Led By Naim M Maalouf, MD

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 weeks

Awards & highlights

Study Summary

This trial will test whether citric acid or potassium citrate can reduce the amount of calcium phosphate in urine of people who form calcium phosphate stones.

Eligible Conditions

Kidney Stones

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Urinary Calcium Phosphate Saturation

Trial Design

6Treatment groups

Experimental Treatment

Group I: Potassium Citrate, then Placebo, then Citric AcidExperimental Treatment3 Interventions

Participants will receive at random, First intervention (1 week), then experience a washout period (1 week) and then receive Second Intervention (1 week) followed by another washout period of 1 week to finally receive the Third Intervention (1 week)

Group II: Potassium Citrate, then Citric Acid, then PlaceboExperimental Treatment3 Interventions

Group III: Placebo, then Potassium Citrate, then Citric AcidExperimental Treatment3 Interventions

Group IV: Placebo, then Citric Acid, then Potassium CitrateExperimental Treatment3 Interventions

Group V: Citric Acid, then Potassium Citrate, then PlaceboExperimental Treatment3 Interventions

Group VI: Citric Acid, then Placebo, then Potassium CitrateExperimental Treatment3 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

Potassium Citrate

2012

Completed Phase 2

~20

Citric Acid

2016

Completed Phase 2

~100

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor

1,047 Previous Clinical Trials

1,053,786 Total Patients Enrolled

5 Trials studying Kidney Stones

652 Patients Enrolled for Kidney Stones

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,358 Previous Clinical Trials

4,315,228 Total Patients Enrolled

6 Trials studying Kidney Stones

590 Patients Enrolled for Kidney Stones

Naim M Maalouf, MDPrincipal InvestigatorUT Southwestern Medical Center

1 Previous Clinical Trials

24 Total Patients Enrolled

Frequently Asked Questions

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

What indications does this medication typically address?

"This treatment can help patients suffering from sodium and fluid retention, recurrent nephrolithiasis, and congestive heart failure (chf)."

Answered by AI

Has this particular medication been cleared for use by the FDA?

"This is a Phase 2 trial, which means that there is some safety data but no efficacy data, so our team at Power rates the safety as a 2."

Answered by AI

Are we still able to enroll new participants in this clinical research project?

"The clinical trial is presently recruiting participants, as indicated by clinicaltrials.gov. This trial was initially posted on 7/1/2012 and was last edited on 1/27/2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Treatment for Calcium Phosphate Kidney Stone Disease

Naim Maalouf 2012. "Treatment for Calcium Phosphate Kidney Stone Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01754779.