A Novel Approach for Reducing Hyperoxaluria and Kidney Stone Risk.
- Registration Number
- NCT06481150
- Lead Sponsor
- University of Texas Southwestern Medical Center
- 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 information.This 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 10
- Normal, healthy adult volunteers
- Personal history of kidney stones
- Pregnant or nursing
- Recurrent urinary tract infections
- Lithogenic urine chemistry at baseline (oxalate > 45 mg/24 h, urine calcium > 300 mg/24 h)
- Chronic kidney disease (eGFR < 90 mL/min/1.73m2)
- Personal history of GI disease, GI obstruction, or GI surgery
- Chronic diarrhea
- Intestinal inflammation (Fecal calprotectin > 120 mcg/g)
- Drugs which are substrates of OATP2B1 (e.g. enalapril)
- Chronic use of sodium polystyrene sulfonate, angiotensin-converting enzyme inhibitors, diuretics, antacids, alkali treatment, or carbonic anhydrase inhibitors.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Tenapanor Tenapanor 30 mg Tenapanor twice a day Placebo Placebo 30 mg Placebo twice a day
- Primary Outcome Measures
Name Time Method 24-h urine oxalate Two 24-h urine on days 4 and 5 of each arm Study participants collect two 24-hour urine specimens for analysis of their stone-risk profile, including oxalate (mg/24 h), comparing placebo with drug treatment (Tenapanor).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
UT Southwestern Medical Center
🇺🇸Dallas, Texas, United States