Trial · NCT00853242
Randomized Study Comparing Genz-644470, Placebo, and Sevelamer Carbonate in Chronic Kidney Disease Patients on Hemodialysis
NCT00853242, Phase 2, Completed, Genzyme, a Sanofi Company; results first posted 2015-05-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Randomized Study Comparing Genz-644470, Placebo, and Sevelamer Carbonate in Chronic Kidney Disease Patients on Hemodialysis. Trials, record NCT00853242. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00853242
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Randomized Study Comparing Genz-644470, Placebo, and Sevelamer Carbonate in Chronic Kidney Disease Patients on Hemodialysis
- NCT number
- NCT00853242
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 349 participants, actual
- Lead sponsor
- Genzyme, a Sanofi Company
- Conditions
- Kidney Failure, Chronic
- Interventions
- Placebo, Genz-644470, Sevelamer carbonate
- First posted
- 2009-03-02
- Last updated
- 2015-05-01
- Results first posted
- 2015-05-01
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Serum Phosphorus at Day 22 (Genz-644470 vs Placebo) | Baseline, Day 22 | |
| Secondary | Change From Baseline in Serum Phosphorus at Day 22 (Genz-644470 vs Sevelamer Carbonate) | Baseline, Day 22 | |
| Secondary | Change From Baseline in Serum Calcium (Albumin-adjusted)-Phosphorus Product at Week 22 | Baseline, Day 22 | |
| Secondary | Change From Baseline in Total Cholesterol at Day 22 | Baseline, Day 22 | |
| Secondary | Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol at Day 22 | Baseline, Day 22 |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Serum Phosphorus at Day 22 (Genz-644470 vs Placebo) | Baseline, Day 22 | Full Analysis Set (FAS) included all participants who received at least one dose of study drug and had baseline and at least one post-baseline phosphorus measure less than or equal to (\<=) 3 days after date of last study drug. | mg/dL | MEAN |
| SECONDARY | Change From Baseline in Serum Phosphorus at Day 22 (Genz-644470 vs Sevelamer Carbonate) | Baseline, Day 22 | FAS included all participants who received at least one dose of study drug and had baseline and at least one post-baseline phosphorus measure \<= 3 days after date of last study drug. | mg/dL | MEAN |
| SECONDARY | Change From Baseline in Serum Calcium (Albumin-adjusted)-Phosphorus Product at Week 22 | Baseline, Day 22 | Full Analysis Set. | mg^2/dL^2 | MEAN |
| SECONDARY | Change From Baseline in Total Cholesterol at Day 22 | Baseline, Day 22 | Full Analysis Set. | mg/dL | MEAN |
| SECONDARY | Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol at Day 22 | Baseline, Day 22 | Full Analysis Set. | mg/dL | MEAN |
Source ClinicalTrials.gov
Results by group31
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Serum Phosphorus at Day 22 (Genz-644470 vs Placebo) | Placebo | -0.0 | Standard Deviation 1.3 | mg/dL | |
| Change From Baseline in Serum Phosphorus at Day 22 (Genz-644470 vs Placebo) | Genz-644470 2.4 g/Day | -0.6 | Standard Deviation 1.5 | mg/dL | |
| Change From Baseline in Serum Phosphorus at Day 22 (Genz-644470 vs Placebo) | Genz-644470 4.8 g/Day | -1.2 | Standard Deviation 1.6 | mg/dL | |
| Change From Baseline in Serum Phosphorus at Day 22 (Genz-644470 vs Placebo) | Genz-644470 7.2 g/Day | -1.8 | Standard Deviation 1.9 | mg/dL | |
| Change From Baseline in Serum Phosphorus at Day 22 (Genz-644470 vs Sevelamer Carbonate) | Genz-644470 2.4 g/Day | -0.6 | Standard Deviation 1.5 | mg/dL | |
| Change From Baseline in Serum Phosphorus at Day 22 (Genz-644470 vs Sevelamer Carbonate) | Genz-644470 4.8 g/Day | -1.2 | Standard Deviation 1.6 | mg/dL | |
| Change From Baseline in Serum Phosphorus at Day 22 (Genz-644470 vs Sevelamer Carbonate) | Genz-644470 7.2 g/Day | -1.8 | Standard Deviation 1.9 | mg/dL | |
| Change From Baseline in Serum Phosphorus at Day 22 (Genz-644470 vs Sevelamer Carbonate) | Sevelamer Carbonate 2.4 g/Day | -0.9 | Standard Deviation 1.7 | mg/dL | |
| Change From Baseline in Serum Phosphorus at Day 22 (Genz-644470 vs Sevelamer Carbonate) | Sevelamer Carbonate 4.8 g/Day | -1.3 | Standard Deviation 1.9 | mg/dL | |
| Change From Baseline in Serum Phosphorus at Day 22 (Genz-644470 vs Sevelamer Carbonate) | Sevelamer Carbonate 7.2 g/Day | -2.0 | Standard Deviation 1.4 | mg/dL |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 results by groupParticipant flow28
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 50 | |
| Overall Study | STARTED | Genz-644470 2.4 Grams Per Day (g/Day) | 50 | |
| Overall Study | STARTED | Genz-644470 4.8 g/Day | 49 | |
| Overall Study | STARTED | Genz-644470 7.2 g/Day | 50 | |
| Overall Study | STARTED | Sevelamer Carbonate 2.4 g/Day | 50 | |
| Overall Study | STARTED | Sevelamer Carbonate 4.8 g/Day | 51 | |
| Overall Study | STARTED | Sevelamer Carbonate 7.2 g/Day | 49 | |
| Overall Study | Treated | Placebo | 50 | |
| Overall Study | Treated | Genz-644470 2.4 Grams Per Day (g/Day) | 49 | |
| Overall Study | Treated | Genz-644470 4.8 g/Day | 48 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 participant flowAdverse events1,113
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 1 | 50 | |
| other | Anaemia | Blood and lymphatic system disorders | Genz-644470 2.4 g/Day | 1 | 49 | |
| other | Anaemia | Blood and lymphatic system disorders | Genz-644470 4.8 g/Day | 0 | 48 | |
| other | Anaemia | Blood and lymphatic system disorders | Genz-644470 7.2 g/Day | 0 | 50 | |
| other | Anaemia | Blood and lymphatic system disorders | Sevelamer Carbonate 2.4 g/Day | 1 | 50 | |
| other | Anaemia | Blood and lymphatic system disorders | Sevelamer Carbonate 4.8 g/Day | 0 | 51 | |
| other | Anaemia | Blood and lymphatic system disorders | Sevelamer Carbonate 7.2 g/Day | 0 | 48 | |
| other | Monocytosis | Blood and lymphatic system disorders | Placebo | 0 | 50 | |
| other | Monocytosis | Blood and lymphatic system disorders | Genz-644470 2.4 g/Day | 0 | 49 | |
| other | Monocytosis | Blood and lymphatic system disorders | Genz-644470 4.8 g/Day | 0 | 48 |
1 to 10 of 1,113Source ClinicalTrials.gov
See all 1,113 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Genz-644470 2.4 g/Day | ||
| Total, all-cause mortality | Genz-644470 4.8 g/Day | ||
| Total, all-cause mortality | Genz-644470 7.2 g/Day | ||
| Total, all-cause mortality | Sevelamer Carbonate 2.4 g/Day | ||
| Total, all-cause mortality | Sevelamer Carbonate 4.8 g/Day | ||
| Total, all-cause mortality | Sevelamer Carbonate 7.2 g/Day | ||
| Total, other adverse events | Placebo | 17 | 50 |
| Total, other adverse events | Genz-644470 2.4 g/Day | 17 | 49 |
| Total, other adverse events | Genz-644470 4.8 g/Day | 17 | 48 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40576086 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00853242
GET https://conductscience.org/api/trials/v1/NCT00853242/results?page=2