A clinical study to investigate how MCI-196 lowers phosphate levels in patients over a long period of time, who have previously participated in the short-term MCI-196 studies and suffer from hyperphosphatemia (high levels of phopshorus in the blood), who have stage 5 chronic kidney disease and are on dialysis or who have stages 3b to 5 chronic kidney disease and are not on dialysis. MCI-196 phosphate-lowering effect will be compated to patients taking calcium-based phosphate binders.
- Conditions
- HyperphosphataemiaMedDRA version: 17.1Level: PTClassification code 10020711Term: HyperphosphataemiaSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Symptoms and general pathology [C23]
- Registration Number
- EUCTR2012-002583-27-DE
- Lead Sponsor
- Mitsubishi Tanabe Pharma Corporation (MTPC)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
• The subject and/or parent(s)/guardian(s) must be capable of providing informed consent, and assent when applicable, in agreement with regional requirements.
• The subject has completed either of the short-term studies, MCI-196-E14 or MCI-196-E16
or
• The subject has been withdrawn from MCI-196-E14, but is eligible to enter this study according to the following rules, as defined in MCI-196-E14:
1.Hyperphosphataemia: Subjects who experienced hyperphosphataemia, defined as any increase in serum phosphorus [P] levels above the age-related ULN on two consecutive occasions, and was withdrawn by the Investigator in order to proceed to this study, where flexible dosing with colestilan (MCI-196) is available. Subjects withdrawn from MCI-196-E14 due to hyperphosphataemia may only enter this study after Week 6 of the short-term study, following two consecutive out-of-range P values (one obtained at Week 3 and one obtained at Week 6). After Week 6, subjects meeting the above criteria may enter this study at any time (the two consecutive out-of-range P values having been obtained any time after Week 6 from a scheduled or unscheduled visit).
2.Hypercalcaemia: Subjects treated with CBPB and experiencing hypercalcaemia may be withdrawn from the short-term study at the discretion of the Investigator in order to proceed to this study at any time, where flexible dosing with colestilan (MCI-196) is available.
Are the trial subjects under 18? yes
Number of subjects for this age range: 100
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
• The subject has current clinically significant medical co-morbidities, 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, make the subject unsuitable for inclusion in the study (e.g., the subject currently has or has had a history of seizure disorders, dysphagia, swallowing disorders, predisposition to or current bowel obstruction, ileus or severe gastrointestinal [GI] disorders such as chronic or severe constipation (as judged by the Investigator), intestinal stenosis, intestinal diverticulum, sigmoid colitis, GI ulcers, current or a history of GI bleeding, or major GI tract surgery).
• The subject is expected to receive immunosuppressant treatment during the course of the study.
• The subject is considered unstable on his/her current treatment for CKD within one month prior to enrolment (e.g., subjects starting treatment with vitamin D or its analogues, or other agents/procedures that may influence bone mineral metabolism [i.e., serum P and calcium (Ca) levels]).
• The subject is considered to be non-compliant with study procedures in the opinion of the Investigator.
• The subject has a temporary catheter as a vascular access and is showing active signs of inflammation as a result of this, which would significantly interfere with dialysis.
• If on peritoneal dialysis, the subject has a recent history of peritonitis (as judged by the Investigator).
Refer to the protocol for a complete list of the exclusion criteria.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the long-term efficacy of treatment with colestilan (MCI-196) (including combination therapy)<br><br>To assess the long-term safety of treatment with colestilan (MCI-196) (including combination therapy).;Secondary Objective: To assess the long-term efficacy profile for colestilan (MCI-196) (monotherapy and combination therapy) versus a standard calcium-based phosphate binder (CBPB) therapy.<br><br>To assess the long-term safety profile for colestilan (MCI-196)(monotherapy and combination therapy) versus a standard CBPB therapy.;Primary end point(s): The primary efficacy endpoint of this study is the proportion of responders at Week 52 or last observation carried forward (LOCF). (Responders are defined as subjects demonstrating serum P levels =1.5 standard deviation above the Kidney Disease Outcomes Quality Initiative (KDOQI) 2008 age-related mean value at Week 52 or LOCF.);Timepoint(s) of evaluation of this end point: Week 52 or last observation carried forward (LOCF).
- Secondary Outcome Measures
Name Time Method