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Tenapanor for Kidney Stones
Phase 4
Recruiting
Led By Jonathan M Whittamore, Ph.D.
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
Normal, healthy adult volunteers
Be older than 18 years old
Must not have
Chronic kidney disease (eGFR < 90 mL/min/1.73m2)
Drugs which are substrates of OATP2B1 (e.g. enalapril)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up two 24-h urine on days 4 and 5 of each arm
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
Summary
This trial aims to test whether a drug called Tenapanor, which is currently used to treat a kidney disease-related condition, can also help reduce the absorption of oxalate in the intestines.
Who is the study for?
This trial is for individuals with high urinary oxalate levels (hyperoxaluria) and those at risk of kidney stones. Participants should be adults who have not been diagnosed with chronic kidney disease but are experiencing these conditions.
What is being tested?
The study tests Tenapanor, a drug approved for another kidney condition, to see if it can also reduce the absorption of oxalate from food and lower the risk of kidney stones. A placebo group will serve as a comparison to measure Tenapanor's effectiveness.
What are the potential side effects?
Possible side effects include digestive issues like diarrhea since Tenapanor affects ion absorption in the intestines. Other side effects may relate to changes in electrolyte levels due to its mechanism of action.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a healthy adult.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My kidney function is reduced.
Select...
I am not taking drugs like enalapril that affect certain body processes.
Select...
I have had kidney stones in the past.
Select...
I have had GI diseases, blockages, or surgeries in the past.
Select...
I frequently get urinary tract infections.
Select...
I have chronic diarrhea.
Select...
I regularly use medications like water pills, blood pressure meds, or antacids.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ two 24-h urine on days 4 and 5 of each arm
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~two 24-h urine on days 4 and 5 of each arm
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
24-h urine oxalate
Side effects data
From 2021 Phase 4 trial • 333 Patients • NCT0454959739%
Diarrhea
2%
Acute Myocardial Infarction
2%
Hyperkalemia
1%
Dyspnoea
1%
Covid-19
1%
Cerebrovascular Accident
1%
Fluid Overload
1%
Chest Pain
1%
Vascular Graft Occlusion
1%
Sepsis
1%
Hypoglycemia
1%
Diabetic Foot
1%
Pneumonia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1
Cohort 2
Cohort 3: Phosphate Binder Naïve
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: TenapanorExperimental Treatment1 Intervention
30 mg Tenapanor twice a day
Group II: PlaceboPlacebo Group1 Intervention
30 mg Placebo twice a day
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tenapanor
2016
Completed Phase 4
~4040
Find a Location
Who is running the clinical trial?
University of Texas Southwestern Medical CenterLead Sponsor
1,089 Previous Clinical Trials
1,059,673 Total Patients Enrolled
National Center for Advancing Translational Sciences (NCATS)NIH
377 Previous Clinical Trials
413,017 Total Patients Enrolled
Jonathan M Whittamore, Ph.D.Principal InvestigatorUniversity of Texas Southwestern Medical Center