Trial · NCT00416520
A Phase III, Multicentre, Double-Blind, Placebo-Controlled Withdrawal Study in Patients With Hyperphosphatemia
NCT00416520, Phase 3, Completed, Tanabe Pharma Corporation; results first posted 2014-10-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase III, Multicentre, Double-Blind, Placebo-Controlled Withdrawal Study in Patients With Hyperphosphatemia. Trials, record NCT00416520. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00416520
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase III, Multicentre, Double-Blind, Placebo-Controlled Withdrawal Study in Patients With Hyperphosphatemia
- NCT number
- NCT00416520
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 336 participants, actual
- Lead sponsor
- Tanabe Pharma Corporation
- Conditions
- Chronic Kidney Disease, Hyperphosphatemia
- Interventions
- MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®), Placebo, Another phosphate binder (Sevelamer)
- First posted
- 2006-12-28
- Last updated
- 2026-01-08
- Results first posted
- 2014-10-23
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Serum Phosphorus Levels From Week 12 to Week 16 (LOCF) (ITT2) | week16 minus week12 | ITT2 population included all re-randomised subjects who completed 12 weeks in the MCI-196 treatment group and received at least 1 dose of study medication in the placebo-controlled withdrawal period and had at least 1 central serum phosphorus value after 12 weeks. |
| Secondary | Change in Serum Phosphorus Levels From Baseline to Week 12 (LOCF) (ITT1) | week12 minus week0 | ITT1 population included all subjects who received a randomisation number (at Week 0), took at least 1 dose of study medication and had at least 1 central serum phosphorus value after the start of study medication. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Serum Phosphorus Levels From Week 12 to Week 16 (LOCF) (ITT2) | week16 minus week12 | ITT2 population included all re-randomised subjects who completed 12 weeks in the MCI-196 treatment group and received at least 1 dose of study medication in the placebo-controlled withdrawal period and had at least 1 central serum phosphorus value after 12 weeks. | mg / dL | MEAN |
| SECONDARY | Change in Serum Phosphorus Levels From Baseline to Week 12 (LOCF) (ITT1) | week12 minus week0 | ITT1 population included all subjects who received a randomisation number (at Week 0), took at least 1 dose of study medication and had at least 1 central serum phosphorus value after the start of study medication. | mg / dL | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Serum Phosphorus Levels From Week 12 to Week 16 (LOCF) (ITT2) | MCI-196 (Placebo-controlled Withdrawal Period) | -0.24 | Standard Deviation 1.46 | mg / dL | |
| Change in Serum Phosphorus Levels From Week 12 to Week 16 (LOCF) (ITT2) | Placebo (Placebo-controlled Withdrawal Period) | 1.27 | Standard Deviation 1.48 | mg / dL | |
| Change in Serum Phosphorus Levels From Baseline to Week 12 (LOCF) (ITT1) | MCI-196 (Open-label Period) | -1.12 | Standard Deviation 1.63 | mg / dL | |
| Change in Serum Phosphorus Levels From Baseline to Week 12 (LOCF) (ITT1) | Sevelamer (Open-label Period) | -2.16 | Standard Deviation 1.55 | mg / dL |
Source ClinicalTrials.gov
Participant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Open-label Period | STARTED | MCI-196 (Open-label Period) | 165 | |
| Open-label Period | STARTED | Sevelamer (Open-label Period) | 171 | |
| Open-label Period | STARTED | MCI-196 (Placebo-controlled Withdrawal Period) | 0 | |
| Open-label Period | STARTED | Placebo (Placebo-controlled Withdrawal Period) | 0 | |
| Open-label Period | COMPLETED | MCI-196 (Open-label Period) | 105 | |
| Open-label Period | COMPLETED | Sevelamer (Open-label Period) | 139 | |
| Open-label Period | COMPLETED | MCI-196 (Placebo-controlled Withdrawal Period) | 0 | |
| Open-label Period | COMPLETED | Placebo (Placebo-controlled Withdrawal Period) | 0 | |
| Open-label Period | NOT COMPLETED | MCI-196 (Open-label Period) | 60 | |
| Open-label Period | NOT COMPLETED | Sevelamer (Open-label Period) | 32 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events640
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 | MCI-196 (Open-label Period) | 6 | 162 | |
| other | Anaemia | Blood and lymphatic system disorders | Sevelamer (Open-label Period) | 6 | 169 | |
| other | Anaemia | Blood and lymphatic system disorders | MCI-196 (Placebo-Controlled Period) | 0 | 50 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo (Placebo-Controlled Period) | 2 | 53 | |
| other | Angina pectoris | Cardiac disorders | MCI-196 (Open-label Period) | 2 | 162 | |
| other | Angina pectoris | Cardiac disorders | Sevelamer (Open-label Period) | 2 | 169 | |
| other | Angina pectoris | Cardiac disorders | MCI-196 (Placebo-Controlled Period) | 0 | 50 | |
| other | Angina pectoris | Cardiac disorders | Placebo (Placebo-Controlled Period) | 0 | 53 | |
| other | Hyperparathyroidism | Endocrine disorders | MCI-196 (Open-label Period) | 2 | 162 | |
| other | Hyperparathyroidism | Endocrine disorders | Sevelamer (Open-label Period) | 1 | 169 |
1 to 10 of 640Source ClinicalTrials.gov
See all 640 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MCI-196 (Open-label Period) | ||
| Total, all-cause mortality | Sevelamer (Open-label Period) | ||
| Total, all-cause mortality | MCI-196 (Placebo-Controlled Period) | ||
| Total, all-cause mortality | Placebo (Placebo-Controlled Period) | ||
| Total, other adverse events | MCI-196 (Open-label Period) | 126 | 162 |
| Total, other adverse events | Sevelamer (Open-label Period) | 113 | 169 |
| Total, other adverse events | MCI-196 (Placebo-Controlled Period) | 20 | 50 |
| Total, other adverse events | Placebo (Placebo-Controlled Period) | 23 | 53 |
| Total, serious adverse events | MCI-196 (Open-label Period) | 26 | 162 |
| Total, serious adverse events | Sevelamer (Open-label Period) | 25 | 169 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 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/NCT00416520
GET https://conductscience.org/api/trials/v1/NCT00416520/flow?page=2