Hyperphosphataemia MedDRA version: 17.1 Level: PT Classification code 10020711 Term: Hyperphosphataemia System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: BindRen® 1 g Film-coated Tablets
Product Code: MCI-196
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: COLESTILAN
CAS Number: 95522-45-5
Current Sponsor code: MCI-196
Concentr
Sponsors
Mitsubishi Tanabe Pharma Corporation (MTPC)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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 • The subject has completed either of the short-term studies, MCI-196-E14 or MCI-196-E16 or • The subject has been withdrawn from MCI-196-E14, but is eligible to enter this study according to the following rules, as defined in MCI-196-E14: 1.Hyperphosphataemia: Subjects who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defined as any increase in serum phosphorus [P] levels above the age-related ULN on two consecutive occasions, and was withdrawn by the Investigator in order to proceed to this study, where flexible dosing with colestilan (MCI-196) is available. Subjects withdrawn from MCI-196-E14 due to hyperphosphataemia may only enter this study after Week 6 of the short-term study, following two consecutive out-of-range P values (one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a scheduled or unscheduled visit). 2.Hypercalcaemia: Subjects treated with CBPB and experiencing hypercalcaemia may be withdrawn from the short-term study at the discretion of the Investigator in order to proceed to this study at any time, where flexible dosing with colestilan (MCI-196)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
Exclusion criteria
Exclusion criteria: • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the long-term efficacy of treatment with colestilan (MCI-196) (including combination therapy) 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. 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): The following secondary efficacy endpoints are to be assessed: Change from baseline in the short-term study (MCI-196-E14 or MCI-196-E16) to Week 25, Week 41, and Week 52 of treatment exposure for the following efficacy parameters: • The mean absolute change from baseline for serum P, Ca and calcium phosphorus ion product (CaxP), intact parathyroid hormone (iPTH), serum glucose, glycosylated haemoglobin (HbA1c), and uric acid • The mean percentage change from baseline for lipid parameters (low-density lipoprotein cholesterol [LDL-C], high-density lipoprotein cholesterol [HDL-C], total cholesterol, and triglycerides [TG]) • The incidence and profile of treatment-emergent adverse events (TEAEs). • The incidence of TEAEs of hypercalcaemia and hypocalcaemia. • Laboratory safety assessments as defined in the protocol. The exploratory substudy endpoint is: High resolution ultrasound measurement of intima media thickness of the common carotid artery as a measure of arterial calcification measured at the baseline visit of the short-term study and at the end of this study. ;Timepoint(s) of evaluation of this end point: The secondary efficacy endpoints are to be assessed Week 25, Week 41, and Week 52 of treatment exposure. The exploratory endpoint of this study is to be assessed at the end of this study. For further information, please refer to the protocol. | — |
Countries
Germany, Turkey
Contacts
Public ContactGeneral Information
Mitsubishi Tanabe Pharma Europe Ltd (MTPE)
Outcome results
None listed