Hyperphosphataemia MedDRA version: 17.1 Level: PT Classification code 10020711 Term: Hyperphosphataemia System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Sponsors
Mitsubishi Tanabe Pharma Corporation (MTPC)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Children aged 2 years to 1.5 standard deviation (SD) above the KDOQI 2008 age-related mean value at any time during the wash-out period (this must be demonstrated after stopping treatment with CBPB) AND • At the time of randomisation, the subject must have demonstrated an increase in serum P levels from his/her most recent P central laboratory measurement by at least 10% above the pre-wash-out level Note: After the wash-out period, should a subject fail to meet either or both of the above two last criteria, the subject is permitted to be re-screened once after an interval of at least three months For a full list of the inclusion criteria please refer to the protocol. Are the trial subjects under 18? yes Number of subjects for this age range: 140 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 been diagnosed with hypocholesterolaemia (i.e., cholesterol levels below age-related normal ranges, per local practices) • The subject has current clinically significant medical comorbidities, which may substantially compromise subject safety, or expose him/her 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 was treated with a combination of two or more phosphate binders within one month prior to screening • The subject cannot stop treatment (prescription or over-thecounter) of any of the following orally taken medications during the wash-out period: any product containing calcium (Ca), magnesium (Mg), aluminium compounds, sevelamer, lanthanum, ketosteril • The subject is receiving immunosuppressant treatment for any medical condition at the time of randomisation or is expected to receive such treatment during the course of the study • The subject is considered unstable on his/her current treatment for CKD within one month prior to screening (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 Ca levels]) For a full list of the exclusion criteria please refer to the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the initial starting doses of colestilan (MCI-196) in paediatric subjects.;Secondary Objective: • To assess the short-term efficacy of colestilan (MCI-196) compared to standard therapy in paediatric subjects • To evaluate the short-term safety of colestilan (MCI-196) compared to standard therapy in paediatric subjects;Primary end point(s): The primary efficacy endpoint of this study is the mean absolute change in serum P levels from baseline to Week 17 or last observation carried forward (LOCF) for all subjects whilst on monotherapy with either fixed-dose of colestilan (MCI-196) or standard therapy of calcium-based phosphate binder (CBPB).;Timepoint(s) of evaluation of this end point: Week 17 or last observation carried forward (LOCF) for all subjects. For further information, please refer to the protocol. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy endpoints (on monotherapy) to be assessed: 1) The proportion of responders in the colestilan (MCI-196) and CBPB treatment arms at Week 17 or LOCF (responders are defined as subjects demonstrating serum P levels =1.5 SD above the KDOQI 2008 age-related mean value) 2) The mean absolute change from baseline to Week 17 (or LOCF) in efficacy laboratory parameters (i.e., Ca, Ca P ion product [CaxP], intact parathyroid hormone [iPTH], serum glucose, glycosylated haemoglobin [HbA1c], and uric acid) 3) The mean percentage change from baseline to Week 17 (or LOCF) in other efficacy laboratory parameters (i.e., lipid parameters [low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C), total cholesterol, and triglycerides (TG)]) Safety endpoints to be assessed: 1) The incidence and profile of treatment-emergent adverse events (TEAEs) 2) The incidence of TEAEs of hypercalcaemia and hypocalcaemia 3) Laboratory safety assessments: a) Morphology parameters: complete blood count, platelet count b) Biochemistry - Electrolytes, mineral parameters, and acid-base balance – sodium (Na), potassium (K), chloride (Cl), Mg, Ca, P, CaxP, bicarbonate (HCO3), pH - Lipids - LDL-C, total cholesterol, HDL-C, TG - Liver Function Tests and glucose metabolism - aspartate aminotransferase (AST), alanine aminotransferase (ALT), ?-glutamyl transpeptidase (GGT), bilirubin, alkaline phosphatase (ALP) - Vitamins and microelements - iron and iron-related parameters (total iron-binding capacity and unsaturated iron-binding capacity) – folate, 25-(OH)-vitamin D3, 1,25-(OH)2-vitamin D3, vitamin K - Other - serum glucose, HbA1c, blood urea nitrogen (BUN), serum creatinine, serum albumin, iPTH, Creactive protein (CRP), creatine kinase (CK), uric acid c) Other parameters - Coagulation – prothrombin time (PT), activated partial thromboplastin time (aPTT), international normalised ratio (INR) - Fibroblast Growth Factor | — |
Countries
Germany, Turkey, United Kingdom
Contacts
Public ContactGeneral Information
Mitsubishi Tanabe Pharma Europe Ltd (MTPE)
Outcome results
None listed