A Novel Approach for Reducing Hyperoxaluria and Kidney Stone Risk.

Phase 4 Completed 18 enrolled University of Texas Southwestern Medical Center National Center for Advancing Translational Sciences (NCATS) · collab

RandomizedCrossoverTriple-blindBasic science

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.

Timeline

Start: 2024-07-01
Primary completion: 2025-09-14
Completion: 2025-09-14

Publications

Background King AJ, Siegel M, He Y, Nie B, Wang J, Koo-McCoy S, Minassian NA, Jafri Q, Pan D, Kohler J, Kumaraswamy P, Kozuka K, Lewis JG, Dragoli D, Rosenbaum DP, O'Neill D, Plain A, Greasley PJ, Jonsson-Rylander AC, Karlsson D, Behrendt M, Stromstedt M, Ryden-Bergsten T, Knopfel T, Pastor Arroyo EM, Hernando N, Marks J, Donowitz M, Wagner CA, Alexander RT, Caldwell JS. Inhibition of sodium/hydrogen exchanger 3 in the gastrointestinal tract by tenapanor reduces paracellular phosphate permeability. Sci Transl Med. 2018 Aug 29;10(456):eaam6474. doi: 10.1126/scitranslmed.aam6474.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tenapanor	Small molecule	30 mg	—

Indications

No indication recorded.