Trial · NCT00542386

A Study of MCI-196 in Chronic Kidney Disease Subjects on Dialysis With Hyperphosphatemia and Dyslipidaemia

NCT00542386, Phase 3, Completed, Tanabe Pharma Corporation; results first posted 2014-10-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of MCI-196 in Chronic Kidney Disease Subjects on Dialysis With Hyperphosphatemia and Dyslipidaemia. Trials, record NCT00542386. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00542386

On this page

Trial

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

Title: A Study of MCI-196 in Chronic Kidney Disease Subjects on Dialysis With Hyperphosphatemia and Dyslipidaemia
NCT number: NCT00542386
Status: Completed
Phases: Phase 3
Enrollment: 642 participants, actual
Lead sponsor: Tanabe Pharma Corporation
Conditions: Chronic Kidney Disease, Dialysis, Hyperphosphatemia, Dyslipidemia
Interventions: MCI-196, Placebo
First posted: 2007-10-11
Last updated: 2026-01-08
Results first posted: 2014-10-06

Source ClinicalTrials.gov

Registered outcomes9

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

List	Outcome	Time frame	Description
Primary	The Change in Serum Phosphorus	12 weeks	The change from baseline to week 12
Primary	The Change in LDL-cholesterol	12 weeks	The percentage change from baseline to week 12
Secondary	The Change in Total-cholesterol	12 weeks
Secondary	The Change in HDL-cholesterol	12 weeks
Secondary	The Change in Triglycerides	12 weeks
Secondary	The Change in PTH	12 weeks
Secondary	The Change in Ca	12 weeks
Secondary	The Change in Ca x P Ion Product	12 weeks
Secondary	The Incidence of Adverse Events	12 weeks

Source ClinicalTrials.gov

Outcomes9

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	12 weeks	ITT: The ITT population included all subjects who received a randomisation number, took study medication, and had at least 1 central laboratory serum phosphorus or LDL-C value after the start	mg/dL	MEAN
PRIMARY	The Change in LDL-cholesterol	12 weeks	ITT: The ITT population included all subjects who received a randomisation number, took study medication, and had at least 1 central laboratory serum phosphorus or LDL-C value after the start of study medication.	Percent change	MEAN
SECONDARY	The Change in Total-cholesterol	12 weeks
SECONDARY	The Change in HDL-cholesterol	12 weeks
SECONDARY	The Change in Triglycerides	12 weeks
SECONDARY	The Change in PTH	12 weeks
SECONDARY	The Change in Ca	12 weeks
SECONDARY	The Change in Ca x P Ion Product	12 weeks
SECONDARY	The Incidence of Adverse Events	12 weeks

Source ClinicalTrials.gov

Results by group12

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	MCI-196: 3 g	-0.23	Standard Deviation 1.62	mg/dL
The Change in Serum Phosphorus	MCI-196: 6 g	-0.77	Standard Deviation 1.97	mg/dL
The Change in Serum Phosphorus	MCI-196: 9 g	-0.97	Standard Deviation 1.68	mg/dL
The Change in Serum Phosphorus	MCI-196: 12 g	-0.71	Standard Deviation 1.84	mg/dL
The Change in Serum Phosphorus	MCI-196: 15 g	-1.41	Standard Deviation 1.43	mg/dL
The Change in Serum Phosphorus	Pooled Placebo	-0.12	Standard Deviation 1.70	mg/dL
The Change in LDL-cholesterol	MCI-196: 3 g	-16.66	Standard Deviation 20.05	Percent change
The Change in LDL-cholesterol	MCI-196: 6 g	-23.56	Standard Deviation 20.99	Percent change
The Change in LDL-cholesterol	MCI-196: 9 g	-27.64	Standard Deviation 21.45	Percent change
The Change in LDL-cholesterol	MCI-196: 12 g	-29.44	Standard Deviation 25.28	Percent change

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow18

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

Period	Milestone	Group	Participants
Overall Study	STARTED	MCI-196: 3 g	104
Overall Study	STARTED	MCI-196: 6 g	102
Overall Study	STARTED	MCI-196: 9 g	99
Overall Study	STARTED	MCI-196: 12 g	103
Overall Study	STARTED	MCI-196: 15 g	102
Overall Study	STARTED	Pooled Placebo	132
Overall Study	COMPLETED	MCI-196: 3 g	61
Overall Study	COMPLETED	MCI-196: 6 g	74
Overall Study	COMPLETED	MCI-196: 9 g	66
Overall Study	COMPLETED	MCI-196: 12 g	65

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events1,542

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: 3 g	1	104
other	Anaemia	Blood and lymphatic system disorders	MCI-196: 6 g	1	102
other	Anaemia	Blood and lymphatic system disorders	MCI-196: 9 g	0	98
other	Anaemia	Blood and lymphatic system disorders	MCI-196: 12 g	1	102
other	Anaemia	Blood and lymphatic system disorders	MCI-196: 15 g	2	101
other	Anaemia	Blood and lymphatic system disorders	Pooled Placebo	0	132
other	Haemorrhagic disorder	Blood and lymphatic system disorders	MCI-196: 3 g	0	104
other	Haemorrhagic disorder	Blood and lymphatic system disorders	MCI-196: 6 g	0	102
other	Haemorrhagic disorder	Blood and lymphatic system disorders	MCI-196: 9 g	0	98
other	Haemorrhagic disorder	Blood and lymphatic system disorders	MCI-196: 12 g	0	102

1 to 10 of 1,542Source ClinicalTrials.gov

See all 1,542 adverse events

Adverse event totals18

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	MCI-196: 3 g
Total, all-cause mortality	MCI-196: 6 g
Total, all-cause mortality	MCI-196: 9 g
Total, all-cause mortality	MCI-196: 12 g
Total, all-cause mortality	MCI-196: 15 g
Total, all-cause mortality	Pooled Placebo
Total, other adverse events	MCI-196: 3 g	47	104
Total, other adverse events	MCI-196: 6 g	44	102
Total, other adverse events	MCI-196: 9 g	49	98
Total, other adverse events	MCI-196: 12 g	53	102

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse event totals

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/NCT00542386

GET https://conductscience.org/api/trials/v1/NCT00542386/events?page=2

API reference For AI assistants