Clinical trial NCT00506441: A Phase 3, Randomized, Double Blind, Placebo-Controlled, Multi-Center, Withdrawal Study of MCI-196 in CKD on Dialysis With Hyperphosphatemia
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-center, Withdrawal Study Comparing MCI-196 v.s Placebo Following A 12-Week Dose Titration Period With MCI-196 in Stage V Subjects on Dialysis With Hyperphosphatemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Kidney Disease
Dialysis
Hyperphosphatemia
Keywords: Chronic Kidney Disease
Dialysis
Hyperphosphatemia
Phosphate binder
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2007-07-25
Enrollment: 245
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: The Change in Serum Phosphorus From Week 12 to Week 16
timeFrame: 4 weeks (Week 12 to Week 16)
Secondary outcomes:
measure: Change From Baseline in Serum Phosphorus
timeFrame: 12 weeks (Week 0 to Week 12)
measure: Change From Baseline in PTH
timeFrame: 12 weeks
measure: Change From Baseline in Calcium
timeFrame: 12 weeks
measure: Change From Baseline in Calcium x Phosphorus Ion Product
timeFrame: 12 weeks
measure: Change From Baseline in Total Cholesterol
timeFrame: 12 weeks
measure: Change From Baseline in LDL Cholesterol
timeFrame: 12 weeks
measure: Change From Baseline in HDL Cholesterol
timeFrame: 12 weeks
measure: Change From Baseline in VLDL Cholesterol
timeFrame: 12 weeks
measure: Change From Baseline in Triglyceride
timeFrame: 12 weeks
measure: Incidence of Adverse Events
timeFrame: 12 weeks (Week 0-12) and 4 weeks (Week 12-16)
Other outcomes:
Locations:
city: Glendale
country: United States
state: Arizona
city: Tempe
country: United States
state: Arizona
city: Hot Springs
country: United States
state: Arkansas
city: Paragould
country: United States
state: Arkansas
city: Pine Bluff
country: United States
state: Arkansas
city: Fountain Valley
country: United States
state: California
city: La Mesa
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Lynwood
country: United States
state: California
city: Orange
country: United States
state: California
city: San Diego
country: United States
state: California
city: Whittier
country: United States
state: California
city: Brandon
country: United States
state: Florida
city: Hudson
country: United States
state: Florida
city: Lauderdale Lakes
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Augusta
country: United States
state: Georgia
city: Decatur
country: United States
state: Georgia
city: Macon
country: United States
state: Georgia
city: Evanston
country: United States
state: Illinois
city: Evergreen Park
country: United States
state: Illinois
city: Fort Wayne
country: United States
state: Indiana
city: Shreveport
country: United States
state: Louisiana
city: Springfield
country: United States
state: Massachusetts
city: Eatontown
country: United States
state: New Jersey
city: Flushing
country: United States
state: New York
city: Springfield Gardens
country: United States
state: New York
city: Allentown
country: United States
state: Pennsylvania
city: Lewistown
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Columbia
country: United States
state: South Carolina
city: Orangeburg
country: United States
state: South Carolina
city: Sumter
country: United States
state: South Carolina
city: San Antonio
country: United States
state: Texas
city: Alexandria
country: United States
state: Virginia
city: Portsmouth
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: West Allis
country: United States
state: Wisconsin
city: San Juan
country: Puerto Rico
Study officials:
affiliation: Information at Mitsubishi Pharma America
name: Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hertel J, Locatelli F, Spasovski G, Dimkovic N, Wanner C. Randomized, Double-Blind, Placebo-Controlled, Withdrawal Study of Colestilan after Dose Titration in Chronic Kidney Disease Dialysis Patients with Hyperphosphatemia. Nephron. 2015;130(4):229-38. doi: 10.1159/000431289. Epub 2015 Jul 10.