Trial · NCT00858637

Efficacy and Safety Study of MCI-196 Versus Simvastatin for Dyslipidaemia in Chronic Kidney Disease (CKD) Subjects on Dialysis

NCT00858637, Phase 3, Completed, Tanabe Pharma Corporation; results first posted 2014-10-17

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Safety Study of MCI-196 Versus Simvastatin for Dyslipidaemia in Chronic Kidney Disease (CKD) Subjects on Dialysis. Trials, record NCT00858637. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00858637

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Trial

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

Title: Efficacy and Safety Study of MCI-196 Versus Simvastatin for Dyslipidaemia in Chronic Kidney Disease (CKD) Subjects on Dialysis
NCT number: NCT00858637
Status: Completed
Phases: Phase 3
Enrollment: 260 participants, actual
Lead sponsor: Tanabe Pharma Corporation
Conditions: Chronic Kidney Disease
Interventions: MCI-196, Placebo of Simvastatin, Simvastatin, Placebo of MCI-196
First posted: 2009-03-10
Last updated: 2026-01-07
Results first posted: 2014-10-17

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	Percent Change in Serum LDL-cholesterol Levels From Week 16 to Week 20 (LOCF) (ITT2)	week20 minus week16	Percent Change from Week 16 to Week 20 (LOCF)
Secondary	Percent Change in Serum LDL-cholesterol Levels From Baseline to Week 16 (LOCF) (ITT1)	week16 minus week0	Percent Change from Baseline to Week 16 (LOCF)
Secondary	Change in Phosphorus(P), Calcium(Ca), Calcium-phosphorus Ion Product(PxCa) and Parathyroid Hormone (PTH)	16 weeks and 20 weeks
Secondary	Vital Signs, Adverse Events, and Laboratory Values	throughout study

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percent Change in Serum LDL-cholesterol Levels From Week 16 to Week 20 (LOCF) (ITT2)	week20 minus week16	ITT2 population included all re-randomised subjects who completed 16 weeks in the active treatment groups (MCI-196 or simvastatin), received at least 1 dose of study medication in the Placebo-controlled withdrawal phase and had at least 1 central serum LDL-C value after Week 16.	Percent Change of LDL-cholesterol	MEAN
SECONDARY	Percent Change in Serum LDL-cholesterol Levels From Baseline to Week 16 (LOCF) (ITT1)	week16 minus week0	ITT1 population included all subjects who received a randomisation number, took at least 1 dose of study medication and had at least 1 central serum LDL-C value after the start of study medication.	Percent Change of LDL-cholesterol	MEAN
SECONDARY	Change in Phosphorus(P), Calcium(Ca), Calcium-phosphorus Ion Product(PxCa) and Parathyroid Hormone (PTH)	16 weeks and 20 weeks
SECONDARY	Vital Signs, Adverse Events, and Laboratory Values	throughout study

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
Percent Change in Serum LDL-cholesterol Levels From Week 16 to Week 20 (LOCF) (ITT2)	MCI-196 (Active) + Simvastin (Placebo)/ Withdrawal Phase	4.03	Standard Deviation 19.92	Percent Change of LDL-cholesterol
Percent Change in Serum LDL-cholesterol Levels From Week 16 to Week 20 (LOCF) (ITT2)	MCI-196 (Placebo) + Simvastin (Placebo)/ Withdrawal Phase	42.55	Standard Deviation 30.96	Percent Change of LDL-cholesterol
Percent Change in Serum LDL-cholesterol Levels From Week 16 to Week 20 (LOCF) (ITT2)	Simvastin (Active) + MCI-196 (Placebo)/ Withdrawal Phase	2.76	Standard Deviation 18.43	Percent Change of LDL-cholesterol
Percent Change in Serum LDL-cholesterol Levels From Week 16 to Week 20 (LOCF) (ITT2)	Simvastin (Placebo) + MCI-196 (Placebo)/ Withdrawal Phase	49.84	Standard Deviation 41.89	Percent Change of LDL-cholesterol
Percent Change in Serum LDL-cholesterol Levels From Baseline to Week 16 (LOCF) (ITT1)	MCI-196 (Active) + Simvastatin (Placebo)/ Comparison Phase	-25.67	Standard Deviation 19.45	Percent Change of LDL-cholesterol
Percent Change in Serum LDL-cholesterol Levels From Baseline to Week 16 (LOCF) (ITT1)	Simvastatin (Active) + MCI-196 (Placebo)/ Comparion Phase	-26.38	Standard Deviation 22.9	Percent Change of LDL-cholesterol

Source ClinicalTrials.gov

Participant flow36

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

Period	Milestone	Group	Participants
Active Comparison Phase	STARTED	MCI-196 (Active) + Simvastatin (Placebo)/ Comparison Phase	127
Active Comparison Phase	STARTED	MCI-196 (Active) + Simvastin (Placebo)/ Withdrawal Phase	0
Active Comparison Phase	STARTED	MCI-196 (Placebo) + Simvastin (Placebo)/ Withdrawal Phase	0
Active Comparison Phase	STARTED	Simvastatin (Active) + MCI-196 (Placebo)/ Comparion Phase	133
Active Comparison Phase	STARTED	Simvastin (Active) + MCI-196 (Placebo)/ Withdrawal Phase	0
Active Comparison Phase	STARTED	Simvastin (Placebo) + MCI-196 (Placebo)/ Withdrawal Phase	0
Active Comparison Phase	COMPLETED	MCI-196 (Active) + Simvastatin (Placebo)/ Comparison Phase	103
Active Comparison Phase	COMPLETED	MCI-196 (Active) + Simvastin (Placebo)/ Withdrawal Phase	0
Active Comparison Phase	COMPLETED	MCI-196 (Placebo) + Simvastin (Placebo)/ Withdrawal Phase	0
Active Comparison Phase	COMPLETED	Simvastatin (Active) + MCI-196 (Placebo)/ Comparion Phase	115

1 to 10 of 36Source ClinicalTrials.gov

See all 36 participant flow

Adverse events326

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 (Active) + Simvastatin (Placebo)/ Comparison Phase	11	128
other	Anaemia	Blood and lymphatic system disorders	Simvastatin (Active) + MCI-196 (Placebo)/ Comparion Phase	12	131
other	Anaemia vitamin B12 deficiency	Blood and lymphatic system disorders	MCI-196 (Active) + Simvastatin (Placebo)/ Comparison Phase	1	128
other	Anaemia vitamin B12 deficiency	Blood and lymphatic system disorders	Simvastatin (Active) + MCI-196 (Placebo)/ Comparion Phase	0	131
other	Leukocytosis	Blood and lymphatic system disorders	MCI-196 (Active) + Simvastatin (Placebo)/ Comparison Phase	1	128
other	Leukocytosis	Blood and lymphatic system disorders	Simvastatin (Active) + MCI-196 (Placebo)/ Comparion Phase	0	131
other	Nephrogenic anaemia	Blood and lymphatic system disorders	MCI-196 (Active) + Simvastatin (Placebo)/ Comparison Phase	1	128
other	Nephrogenic anaemia	Blood and lymphatic system disorders	Simvastatin (Active) + MCI-196 (Placebo)/ Comparion Phase	0	131
other	Angina pectoris	Cardiac disorders	MCI-196 (Active) + Simvastatin (Placebo)/ Comparison Phase	1	128
other	Angina pectoris	Cardiac disorders	Simvastatin (Active) + MCI-196 (Placebo)/ Comparion Phase	0	131

1 to 10 of 326Source ClinicalTrials.gov

See all 326 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	MCI-196 (Active) + Simvastatin (Placebo)/ Comparison Phase
Total, all-cause mortality	Simvastatin (Active) + MCI-196 (Placebo)/ Comparion Phase
Total, other adverse events	MCI-196 (Active) + Simvastatin (Placebo)/ Comparison Phase	89	128
Total, other adverse events	Simvastatin (Active) + MCI-196 (Placebo)/ Comparion Phase	87	131
Total, serious adverse events	MCI-196 (Active) + Simvastatin (Placebo)/ Comparison Phase	16	128
Total, serious adverse events	Simvastatin (Active) + MCI-196 (Placebo)/ Comparion Phase	12	131

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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 comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
MCI-196 (Active) + Simvastatin (Placebo)/ Comparison Phase vs Simvastatin (Active) + MCI-196 (Placebo)/ Comparion Phase: serious adverse events

Source Trial comparisons

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/NCT00858637

GET https://conductscience.org/api/trials/v1/NCT00858637/flow?page=2

API reference For AI assistants