Phase 2
Completed N=349
Randomized Study Comparing Genz-644470, Placebo, and Sevelamer Carbonate in Chronic Kidney Disease Patients on Hemodialysis
Kidney Failure, Chronic
Source: ClinicalTrials.gov NCT00853242 ↗
Enrolled (actual)
349
Serious AEs
10.4%
Results posted
May 2015
Primary outcomePrimary: Change From Baseline in Serum Phosphorus at Day 22 (Genz-644470 vs Placebo) — -0.0; -0.6; -1.2; -1.8 mg/dL — p=0.0249
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Serum Phosphorus at Day 22 (Genz-644470 vs Placebo) |
-0.0; -0.6; -1.2; -1.8 | 0.0249 sig |
| SECONDARY Change From Baseline in Serum Phosphorus at Day 22 (Genz-644470 vs Sevelamer Carbonate) |
-0.6; -1.2; -1.8; -0.9; -1.3; -2.0 | 0.2647 |
| SECONDARY Change From Baseline in Serum Calcium (Albumin-adjusted)-Phosphorus Product at Week 22 |
-0.1; -4.5; -9.2; -16.1; -8.3; -10.3 | — |
| SECONDARY Change From Baseline in Total Cholesterol at Day 22 |
-3.8; -13.5; -11.2; -17.8; -2.9; -15.8 | — |
| SECONDARY Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol at Day 22 |
-1.3; -15.4; -13.2; -21.9; -7.5; -17.7 | — |
Eligibility Criteria
Inclusion Criteria
- Serum phosphate level greater than (>) 5.5 milligram per deciliter (mg/dL) (1.78 millimole per liter [mmol/L]) after discontinuation of current phosphate binder therapy
- Men or women 18 years or older
Exclusion Criteria
- Have active dysphagia or swallowing disorder or a predisposition to or current bowel obstruction, ileus, or severe gastrointestinal motility disorders including severe constipation
Data sourced from ClinicalTrials.gov (NCT00853242). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.