Study to Assess the Safety and the Phosphate Binding Capacity of Renazorb

Phase 1 Completed 32 enrolled Spectrum Pharmaceuticals, Inc

RandomizedParallel-groupQuadruple-blindBasic science

Summary

The purpose of this trial is to study safety, tolerability, and phosphate binding capacity of Renazorb (SPI-014) in healthy volunteers before conducting trials in patients with renal failure. Renal excretion of phosphate is expected to decrease and fecal excretion of phosphate is expected to increase after treatment.

Timeline

Start: 2012-04
Primary completion: 2012-09
Completion: 2012-09

Publications

Pergola PE, Joy MS, Garsd A, Hasal SJ, Khare A, Reddy G, Gupta P, Finn WF. Safety and Phosphate-Binding Capacity of Oxylanthanum Carbonate in Healthy Volunteers. Clin Transl Sci. 2025 Jan;18(1):e70116. doi: 10.1111/cts.70116.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Oxylanthanum Carbonate	Small molecule	1500 mg	Oral
Comparator	Oxylanthanum Carbonate	Small molecule	3000 mg	Oral
Comparator	Oxylanthanum Carbonate	Small molecule	4500 mg	Oral
Comparator	Oxylanthanum Carbonate	Small molecule	6000 mg	Oral

Indications

No indication recorded.