CompletedNCT00542386Updated Jan 8, 2026Results posted

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

A Phase 3 interventional study of MCI-196 and Placebo in Chronic Kidney Disease, Dialysis and Hyperphosphatemia, sponsored by Tanabe Pharma Corporation. Completed at 73 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-08.

Sponsored by Tanabe Pharma Corporation · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 642
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

This is a phase III multi-centre study in two periods: the first period is a phosphate binder and lipid lowering drugs washout for 8 weeks, the second period is a double-blind, randomised, parallel group, fixed dose, for 12 weeks.

Conditions studied

Chronic Kidney Disease
Dialysis
Hyperphosphatemia
Dyslipidemia

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Keywords

Chronic Kidney Disease
Dialysis
Hyperphosphatemia
Dyslipidemia
Phosphate binder

In context

Renal Insufficiency, Chronic

3,090 studies on the registry are indexed under Renal Insufficiency, Chronic; 698 are open to participants now.

This study's enrollment of 642 is above the median of 73 across 2,157 interventional studies indexed under Renal Insufficiency, Chronic.

Browse Renal Insufficiency, Chronic studies →

Lead sponsor

Tanabe Pharma Corporation is the lead sponsor of 92 studies on the registry; 1 is open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 6 (75%) have results posted.

Browse Tanabe Pharma Corporation studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Male or female, 18 years of age or over
Clinically stable haemodialysis or peritoneal dialysis
Stable phosphate control
On a stabilised phosphorus diet
Female and of have a negative serum pregnancy test
Male subjects must agree to use appropriate

Exclusion criteria

Exclusion Criteria:

Current medical comorbidities, which may substantially compromise subject safety, or expose them to undue risk, or interfere significantly with study procedures and which, in the opinion of the Investigator, makes the subject unsuitable for inclusion in the study.
A a serum albumin level\<30.0g/L
A PTH level >1000pg/mL
A (BMI)\<= 16.0kg/㎡ or =>40.0kg/㎡
A serum LDL-C level >4.94mmol/L(190mg/dL)
A serum triglycerides level >6.76mmol/L (600mg/dL)
A History of significant gastrointestinal motility problems
A positive test for 1 and 2 antibodies
A history of substance or alcohol abuse within the last year
Seizure disorders
A history of drug or other allergy
A temporary catheter as a vascular access
Participated in a clinical study with any experimental medication in the last 30 days or an experimental biological product within the last 90 days prior to signing of

Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 642 participants (actual)

Study arms

Experimental
1
Drug: MCI-196
Placebo comparator
2
Drug: Placebo

Interventions

DrugMCI-196
3g to 15g/day (3 times a day), Tablet, 12 weeks of fixed dose of study
Also known as: Colestilan(INN),, Colestimide(JAN), CHOLEBINE®, BindRen®
DrugPlacebo
3g to 15g/day (3 times a day), Tablet, 12 weeks of fixed dose of study

What researchers measure

Primary outcomes

The Change in Serum Phosphorus
The change from baseline to week 12
Time frame: 12 weeks
The Change in LDL-cholesterol
The percentage change from baseline to week 12
Time frame: 12 weeks

Secondary outcomes

The Change in Total-cholesterol
Time frame: 12 weeks
The Change in HDL-cholesterol
Time frame: 12 weeks
The Change in Triglycerides
Time frame: 12 weeks
The Change in PTH
Time frame: 12 weeks
The Change in Ca
Time frame: 12 weeks
The Change in Ca x P Ion Product
Time frame: 12 weeks
The Incidence of Adverse Events
Time frame: 12 weeks

Results

Posted Oct 6, 2014

Participant flow

Participant flow — Overall Study
Milestone	MCI-196: 3 g	MCI-196: 6 g	MCI-196: 9 g	MCI-196: 12 g	MCI-196: 15 g	Pooled Placebo
Started	104	102	99	103	102	132
Completed	61	74	66	65	62	82
Not completed	43	28	33	38	40	50
Withdrew: Adverse event	1	7	7	8	13	4
Withdrew: Death	0	0	1	2	1	2
Withdrew: Lack of efficacy	32	12	10	13	7	31
Withdrew: Physician decision	1	0	0	1	0	0
Withdrew: Protocol violation	0	0	1	0	0	4
Withdrew: Withdrawal by subject	5	8	10	11	15	7
Withdrew: Other reasons	4	1	4	3	4	2

Outcome measures

PrimaryThe Change in Serum Phosphorus

The change from baseline to week 12

Time frame:: 12 weeks
Reported as:: Mean · mg/dL

The Change in Serum Phosphorus
mg/dL	MCI-196: 3 g	MCI-196: 6 g	MCI-196: 9 g	MCI-196: 12 g	MCI-196: 15 g	Pooled Placebo
The Change in Serum Phosphorus	-0.23 ± 1.62	-0.77 ± 1.97	-0.97 ± 1.68	-0.71 ± 1.84	-1.41 ± 1.43	-0.12 ± 1.70

PrimaryThe Change in LDL-cholesterol

The percentage change from baseline to week 12

Time frame:: 12 weeks
Reported as:: Mean · Percent change

The Change in LDL-cholesterol
Percent change	MCI-196: 3 g	MCI-196: 6 g	MCI-196: 9 g	MCI-196: 12 g	MCI-196: 15 g	Pooled Placebo
The Change in LDL-cholesterol	-16.66 ± 20.05	-23.56 ± 20.99	-27.64 ± 21.45	-29.44 ± 25.28	-27.46 ± 24.57	2.77 ± 17.44

SecondaryThe Change in Total-cholesterol

Time frame:: 12 weeks