A Phase 3, Randomized, Double Blind, Placebo-Controlled, Multi-Center, Withdrawal Study of MCI-19… (NCT00506441) | Clinical Trial Compass
CompletedPhase 3
A Phase 3, Randomized, Double Blind, Placebo-Controlled, Multi-Center, Withdrawal Study of MCI-196 in CKD on Dialysis With Hyperphosphatemia
United States, Puerto Rico245 participantsStarted 2007-09
Plain-language summary
This is a phase III multi-centre study in three periods: the first period is a phosphate binder washout for 4 weeks, the second period is an open-label, flexible dose titration, the third period is a placebo-controlled withdrawal comparing MCI-196 with placebo for 4 weeks.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female, and is \>=18 years old
* Stable hemodialysis or peritoneal dialysis
* Subjects has Stable phosphate control
* Subjects on Stabilized phosphorus diet
* Subjects undergoing regular dialysis treatment
* Female and of child-bearing potential have a negative serum pregnancy test.
* Male subjects must agree to use appropriate contraception.
Exclusion Criteria:
* Current clinically significant 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.
* serum albumin level \< 3.0g/dL
* PTH level \> 1000pg/mL
* Hemoglobin level \< 8mg/dL
* A History of significant gastrointestinal motility problems
* Biliary obstruction or proven liver dysfunction
* A positive test for hepatitis B surface antigen, hepatitis C antibody or HIV 1 and 2 antibodies
* A clinically significant severe lactose intolerance or sensitivity
* A history of substance or alcohol abuse within the last year.
* Seizure disorders
* A history of drug or other allergy
* using cholestyramine, colestipol or colesevelam
* Schedule to receive a kidney transplant within the next 6 months
* Participation 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 informed consent
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The Change in Serum Phosphorus From Week 12 to Week 16