Trial · NCT00506441

A Phase 3, Randomized, Double Blind, Placebo-Controlled, Multi-Center, Withdrawal Study of MCI-196 in CKD on Dialysis With Hyperphosphatemia

NCT00506441, Phase 3, Completed, Tanabe Pharma Corporation; results first posted 2014-07-25

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Phase 3, Randomized, Double Blind, Placebo-Controlled, Multi-Center, Withdrawal Study of MCI-196 in CKD on Dialysis With Hyperphosphatemia. Trials, record NCT00506441. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00506441

On this page

Trial

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

Title: A Phase 3, Randomized, Double Blind, Placebo-Controlled, Multi-Center, Withdrawal Study of MCI-196 in CKD on Dialysis With Hyperphosphatemia
NCT number: NCT00506441
Status: Completed
Phases: Phase 3
Enrollment: 245 participants, actual
Lead sponsor: Tanabe Pharma Corporation
Conditions: Chronic Kidney Disease, Dialysis, Hyperphosphatemia
Interventions: MCI-196, Placebo
First posted: 2007-07-25
Last updated: 2026-01-08
Results first posted: 2014-07-25

Source ClinicalTrials.gov

Registered outcomes11

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

List	Outcome	Time frame	Description
Primary	The Change in Serum Phosphorus From Week 12 to Week 16	4 weeks (Week 12 to Week 16)	The changes in serum phosphorus (mg/dL) from Week 12 to Week 16 (last observation post Week 12)
Secondary	Change From Baseline in Serum Phosphorus	12 weeks (Week 0 to Week 12)
Secondary	Change From Baseline in PTH	12 weeks
Secondary	Change From Baseline in Calcium	12 weeks
Secondary	Change From Baseline in Calcium x Phosphorus Ion Product	12 weeks
Secondary	Change From Baseline in Total Cholesterol	12 weeks
Secondary	Change From Baseline in LDL Cholesterol	12 weeks
Secondary	Change From Baseline in HDL Cholesterol	12 weeks
Secondary	Change From Baseline in VLDL Cholesterol	12 weeks
Secondary	Change From Baseline in Triglyceride	12 weeks

1 to 10 of 11Source ClinicalTrials.gov

See all 11 registered outcomes

Outcomes11

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 From Week 12 to Week 16	4 weeks (Week 12 to Week 16)	Intent-to-treat (ITT) 2 (The ITT2 population included all subjects who complete 12-weeks, receive a randomization number and receive at least one dose of study medication in the placebo-controlled withdrawal phase, either MCI-196 or placebo, and have at least one central phosphorus value after 12-weeks.)	mg / dL	MEAN
SECONDARY	Change From Baseline in Serum Phosphorus	12 weeks (Week 0 to Week 12)	ITT1 (The ITT1 population included all enrolled subjects who have taken at least one dose of study medication and have at least one central phosphorus value after the start of study medication.)	mg/dL	MEAN
SECONDARY	Change From Baseline in PTH	12 weeks
SECONDARY	Change From Baseline in Calcium	12 weeks
SECONDARY	Change From Baseline in Calcium x Phosphorus Ion Product	12 weeks
SECONDARY	Change From Baseline in Total Cholesterol	12 weeks
SECONDARY	Change From Baseline in LDL Cholesterol	12 weeks
SECONDARY	Change From Baseline in HDL Cholesterol	12 weeks
SECONDARY	Change From Baseline in VLDL Cholesterol	12 weeks
SECONDARY	Change From Baseline in Triglyceride	12 weeks

1 to 10 of 11Source ClinicalTrials.gov

See all 11 outcomes

Results by group3

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 From Week 12 to Week 16	MCI-196 (Double-blind Period)	-0.04	Standard Deviation 1.49	mg / dL
The Change in Serum Phosphorus From Week 12 to Week 16	Placebo (Double-blind Period)	0.71	Standard Deviation 1.71	mg / dL
Change From Baseline in Serum Phosphorus	MCI-196 (Open-label Period)	-1.54	95% Confidence Interval -1.80 to -1.28	mg/dL

Source ClinicalTrials.gov

Participant flow12

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

Period	Milestone	Group	Participants
Period 1; Open-label Period	STARTED	MCI-196	245
Period 1; Open-label Period	STARTED	Placebo	0
Period 1; Open-label Period	COMPLETED	MCI-196	169
Period 1; Open-label Period	COMPLETED	Placebo	0
Period 1; Open-label Period	NOT COMPLETED	MCI-196	76
Period 1; Open-label Period	NOT COMPLETED	Placebo	0
Period 2; Double-blind Period	STARTED	MCI-196	85
Period 2; Double-blind Period	STARTED	Placebo	84
Period 2; Double-blind Period	COMPLETED	MCI-196	82
Period 2; Double-blind Period	COMPLETED	Placebo	79

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events834

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	Arteriovenous fistula site haematoma	Injury, poisoning and procedural complications	MCI-196 (Open-label Period)	1	245
other	Arteriovenous fistula site haematoma	Injury, poisoning and procedural complications	MCI-196 (Double-blind Period)	0	86
other	Arteriovenous fistula site haematoma	Injury, poisoning and procedural complications	Placebo (Double-blind Period)	0	83
other	Arteriovenous fistula site complication	Injury, poisoning and procedural complications	MCI-196 (Open-label Period)	11	245
other	Arteriovenous fistula site complication	Injury, poisoning and procedural complications	MCI-196 (Double-blind Period)	1	86
other	Arteriovenous fistula site complication	Injury, poisoning and procedural complications	Placebo (Double-blind Period)	1	83
other	Limb injury	Injury, poisoning and procedural complications	MCI-196 (Open-label Period)	2	245
other	Limb injury	Injury, poisoning and procedural complications	MCI-196 (Double-blind Period)	0	86
other	Limb injury	Injury, poisoning and procedural complications	Placebo (Double-blind Period)	0	83
other	Fall	Injury, poisoning and procedural complications	MCI-196 (Open-label Period)	2	245

1 to 10 of 834Source ClinicalTrials.gov

See all 834 adverse events

Adverse event totals9

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	MCI-196 (Double-blind Period)
Total, all-cause mortality	Placebo (Double-blind Period)
Total, other adverse events	MCI-196 (Open-label Period)	161	245
Total, other adverse events	MCI-196 (Double-blind Period)	34	86
Total, other adverse events	Placebo (Double-blind Period)	25	83
Total, serious adverse events	MCI-196 (Open-label Period)	37	245
Total, serious adverse events	MCI-196 (Double-blind Period)	10	86
Total, serious adverse events	Placebo (Double-blind Period)	7	83

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
26184491	DERIVED	PubMed
40576086	DERIVED	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/NCT00506441

GET https://conductscience.org/api/trials/v1/NCT00506441/events?page=2

API reference For AI assistants