Trial · NCT00542815

A Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia

NCT00542815, Phase 3, Completed, Tanabe Pharma Corporation; results first posted 2014-09-23

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia. Trials, record NCT00542815. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00542815

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia
NCT number: NCT00542815
Status: Completed
Phases: Phase 3
Enrollment: 632 participants, actual
Lead sponsor: Tanabe Pharma Corporation
Conditions: Chronic Kidney Disease, Dialysis, Hyperphosphatemia
Interventions: MCI-196, Another Phosphate binder (Sevelamer)
First posted: 2007-10-12
Last updated: 2026-01-07
Results first posted: 2014-09-23

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	The Change in Serum Phosphorus for MCI-196 and Sevelamer	52 weeks (Baseline-52 weeks)	Change from Baseline to Week 52 (LOCF)
Secondary	The Percent Change in Serum LDL-cholesterol for MCI-196 and Sevelamer	52 weeks (Baseline-52 weeks)	Percent Change from Baseline to Week 52 (LOCF)

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	The Change in Serum Phosphorus for MCI-196 and Sevelamer	52 weeks (Baseline-52 weeks)	ITT2 population included all subjects who received enrolment number into MCI-196-E10, took at least 1 dose of study medication in original study and had at least 1 post-enrolment efficacy value after start of study medication in MCI-196-E10. Data collected from start of original studies to end of MCI-196-E10 were analysed for this population.	mg / dL	MEAN
SECONDARY	The Percent Change in Serum LDL-cholesterol for MCI-196 and Sevelamer	52 weeks (Baseline-52 weeks)	ITT2 population included all subjects who received enrolment number into MCI-196-E10, took at least 1 dose of study medication in original study and had at least 1 post-enrolment efficacy value after start of study medication in MCI-196-E10. Data collected from start of original studies to end of MCI-196-E10 were analysed for this population.	percentage change of LDL-cholesterol	MEAN

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
The Change in Serum Phosphorus for MCI-196 and Sevelamer	MCI-196 From E07 / E08 Studies	-1.23	Standard Deviation 1.78	mg / dL
The Change in Serum Phosphorus for MCI-196 and Sevelamer	MCI-196 From E07 Study	-1.47	Standard Deviation 1.68	mg / dL
The Change in Serum Phosphorus for MCI-196 and Sevelamer	Sevelamer From E07 Study	-2.26	Standard Deviation 1.82	mg / dL
The Percent Change in Serum LDL-cholesterol for MCI-196 and Sevelamer	MCI-196 From E07 / E08 Studies	-26.22	Standard Deviation 27.08	percentage change of LDL-cholesterol
The Percent Change in Serum LDL-cholesterol for MCI-196 and Sevelamer	MCI-196 From E07 Study	-30.62	Standard Deviation 20.12	percentage change of LDL-cholesterol
The Percent Change in Serum LDL-cholesterol for MCI-196 and Sevelamer	Sevelamer From E07 Study	-28.66	Standard Deviation 23.61	percentage change of LDL-cholesterol

Source ClinicalTrials.gov

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	MCI-196 From E07 / E08 Studies	432
Overall Study	STARTED	MCI-196 From E07 Study	76
Overall Study	STARTED	Sevelamer From E07 Study	124
Overall Study	COMPLETED	MCI-196 From E07 / E08 Studies	326
Overall Study	COMPLETED	MCI-196 From E07 Study	44
Overall Study	COMPLETED	Sevelamer From E07 Study	92
Overall Study	NOT COMPLETED	MCI-196 From E07 / E08 Studies	106
Overall Study	NOT COMPLETED	MCI-196 From E07 Study	32
Overall Study	NOT COMPLETED	Sevelamer From E07 Study	32

Source ClinicalTrials.gov

Adverse events726

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
other	Anaemia	Blood and lymphatic system disorders	MCI-196 From E07/E08 Studies	34	432
other	Anaemia	Blood and lymphatic system disorders	MCI-196 From E07 Study	13	76
other	Anaemia	Blood and lymphatic system disorders	Sevelamer From E07 Study	22	124
other	Nephrogenic anaemia	Blood and lymphatic system disorders	MCI-196 From E07/E08 Studies	6	432
other	Nephrogenic anaemia	Blood and lymphatic system disorders	MCI-196 From E07 Study	2	76
other	Nephrogenic anaemia	Blood and lymphatic system disorders	Sevelamer From E07 Study	1	124
other	Angina pectoris	Cardiac disorders	MCI-196 From E07/E08 Studies	5	432
other	Angina pectoris	Cardiac disorders	MCI-196 From E07 Study	1	76
other	Angina pectoris	Cardiac disorders	Sevelamer From E07 Study	4	124
other	Myocardial ischaemia	Cardiac disorders	MCI-196 From E07/E08 Studies	9	432

1 to 10 of 726Source ClinicalTrials.gov

See all 726 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	MCI-196 From E07/E08 Studies
Total, all-cause mortality	MCI-196 From E07 Study
Total, all-cause mortality	Sevelamer From E07 Study
Total, other adverse events	MCI-196 From E07/E08 Studies	310	432
Total, other adverse events	MCI-196 From E07 Study	75	76
Total, other adverse events	Sevelamer From E07 Study	112	124
Total, serious adverse events	MCI-196 From E07/E08 Studies	74	432
Total, serious adverse events	MCI-196 From E07 Study	31	76
Total, serious adverse events	Sevelamer From E07 Study	48	124

Source ClinicalTrials.gov

Papers1

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00542815

GET https://conductscience.org/api/trials/v1/NCT00542815/events?page=2

API reference For AI assistants