Randomized Study Comparing Genz-644470, Placebo, and Sevelamer Carbonate in Chronic Kidney Disease Patients on Hemodialysis

Summary

The purpose of this clinical study is to compare the effects of Genz-644470 with the effects of placebo and sevelamer carbonate (Renvela®) on the reduction of serum phosphorus in hyperphosphatemic chronic kidney disease participants on hemodialysis.

Timeline

Start

2009-02

Primary completion

2009-08

Completion

2009-08

Outcome

Met primary endpoint

registry analysis (superiority or other test); Placebo vs Genz-644470 2.4 g/Day; p = 0.0249; Wilcoxon Rank Sum Tests NCT00853242 ↗

registry analysis (superiority or other test); Placebo vs Genz-644470 4.8 g/Day; p = 0.0001; Wilcoxon Rank Sum Tests NCT00853242 ↗

registry analysis (superiority or other test); Placebo vs Genz-644470 7.2 g/Day; p <0.0001; Wilcoxon Rank Sum Tests NCT00853242 ↗

Publications

• Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Genz-644470	Unknown	2.4 g	Oral
Subject	Genz-644470	Unknown	4.8 g	Oral
Subject	Genz-644470	Unknown	7.2 g	Oral
Comparator	Sevelamer	Other / unclassified	2.4 g	Oral
Comparator	Sevelamer	Other / unclassified	4.8 g	Oral
Comparator	Sevelamer	Other / unclassified	7.2 g	Oral

Indications