Ignite Creation Date:
2024-07-17 @ 10:52 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06481150
Status:
RECRUITING
Last Update Posted:
2024-07-01
First Post:
2024-06-24
Brief Title:
A Novel Approach for Reducing Hyperoxaluria and Kidney Stone Risk
Sponsor:
University of Texas Southwestern Medical Center
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
A Novel Approach for Reducing Hyperoxaluria and Kidney Stone Risk
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This pilot study is proposing a novel approach to directly target intestinal oxalate absorption with the drug Tenapanor which was recently FDA-approved for treating hyperphosphatemia in patients with chronic kidney disease Tenapanor works by blocking paracellular phosphate absorption by the intestine but the underlying mechanisms have not been clearly defined Since phosphate and oxalate ions are absorbed through the same paracellular pathway and are of similar size and charge Tenapanor is hypothesized to also reduce dietary oxalate absorption and consequently lower urinary oxalate excretion
Detailed Description:
The proposed proof-of-concept studies will determine whether Tenapanor reduces urine oxalate in normal human subjects receiving a high-oxalate diet in a crossover placebo-controlled short-term metabolic study
Study Design Screening - One 24-hour urine for analysis of stone-risk profile one blood sample for comprehensive metabolic panel and cystatin C one stool sample for fecal calprotectin physical exam social and medical history vital signs demographic information personal informationThis is a two-phase study each phase is 5 days in duration
Phase 1 The subjects will consume a pre-prepared oxalate-rich metabolic diet for 5 days while taking 30 mg Tenapanor or Placebo twice a day just prior to the morning and evening meals On days 4 and 5 they will collect two 24-hour urines for measurement of urine oxalate and stone-risk profile
Washout The subjects will undergo a 9-day washout period Phase 2 The subjects will consume a pre-prepared oxalate-rich metabolic diet for 5 days while taking 30 mg Tenapanor or Placebo twice a day just prior to the morning and evening meals On days 4 and 5 they will collect two 24-hour urines for measurement of urine oxalate and stone-risk profile
Study Design Screening - One 24-hour urine for analysis of stone-risk profile one blood sample for comprehensive metabolic panel and cystatin C one stool sample for fecal calprotectin physical exam social and medical history vital signs demographic information personal informationThis is a two-phase study each phase is 5 days in duration
Phase 1 The subjects will consume a pre-prepared oxalate-rich metabolic diet for 5 days while taking 30 mg Tenapanor or Placebo twice a day just prior to the morning and evening meals On days 4 and 5 they will collect two 24-hour urines for measurement of urine oxalate and stone-risk profile
Washout The subjects will undergo a 9-day washout period Phase 2 The subjects will consume a pre-prepared oxalate-rich metabolic diet for 5 days while taking 30 mg Tenapanor or Placebo twice a day just prior to the morning and evening meals On days 4 and 5 they will collect two 24-hour urines for measurement of urine oxalate and stone-risk profile
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1UL1TR003163 | NIH | None | None |