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: Main inclusion criteria for enrolment into this study: • Children aged 2 years to 1.5 standard deviation (SD) above the KDOQI 2008 age-related mean value at any time during the screening period. Such subjects do not require wash-out and should proceed to baseline for the next visit if additional screening visits are not required. Baseline inclusion criteria for subjects treated with phosphate binders: • The subject must have demonstrated serum P levels >1.5 SD above the KDOQ 2008 age-related mean value at any time during the wash-out period (after stopping phosphate binders), and; • The subject must demonstrate an increase in serum P levels by at least 10% above the pre wash-out level (after stopping phosphate binders). Note: should a subject fail to meet any of the above criteria, the subject is permitted to be re-screened once after an interval of at least three months. Refer to protocol for a complete list of inclusion criteria. Are the trial subjects under 18? yes Number of subjects for this age range: 45 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: A subject meeting any of the following criteria is ineligible to participate in this study: • 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 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 cannot stop treatment (prescription or over-the-counter) 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 baseline visit or is expected to receive such treatment during the course of the study • The subject is considered as 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] Exclusion criteria for subjects treated with phosphate binders: • The subject was treated with a combination of two or more phosphate binders within one month prior to screening Refer to protocol for a complete list of exclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety and tolerability of colestilan (MCI-196) in paediatric subjects (aged 2 years to <18 years) with CKD stages 3b to 5, diagnosed with hyperphosphataemia, who are not on dialysis.;Secondary Objective: Not applicable;Primary end point(s): The percentage of subjects who, due to hyperphosphataemia, require rescue treatment and/or discontinuation of therapy with colestilan (MCI-196).;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): Safety endpoints: 1) The incidence and profile of treatment-emergent adverse events (TEAEs) 2) The incidence of TEAEs of hypercalcaemia and hypocalcaemia 3) Laboratory safety assessments: o Morphology parameters: complete blood count (CBC), platelet count o Biochemistry - Electrolytes, mineral parameters, and acid-base balance – sodium (Na), potassium (K), chloride (Cl), magnesium (Mg), calcium (Ca), P, calcium phosphorus ion product (CaxP), bicarbonate (HCO3), pH - Lipids – low density lipoprotein cholesterol (LDL-C), total cholesterol, high density lipoprotein cholesterol (HDL-C), triglycerides (TG) - Liver Function Tests (LFTs) – 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 [TIBC], unsaturated iron-binding capacity[UIBC]), folate, 25-(OH)-vitamin D3, 1,25-(OH)2-vitamin D3, vitamin K - Other - blood urea nitrogen (BUN), serum creatinine, serum albumin, intact parathyroid hormone (iPTH), C-reactive protein (CRP), creatine kinase (CK), serum glucose, HbA1c, and uric acid o Other parameters: - Coagulation: prothrombin time (PT), activated partial thromboplastin time (aPTT), international normalised ratio (INR) - Fibroblast Growth Factor 23 (FGF23) Efficacy endpoints 1)The mean absolute change in serum P levels from baseline to Week 17 or last observation carried forward (LOCF) in subjects receiving colestilan (MCI-196) only. 2) The proportion of responders at Week 17 or LOCF (responders are defined as subjects demonstrating serum P levels =1.5 standard deviation [SD] above the age-related KDOQI 2008 mean value at Week 17 or LOCF. LOCF will be applied at the time of rescue or withdrawal. A sensitivity analysis will also be performed where LOCF is taken at time of withdrawal only. The other/exploratory endpoint is the acceptability and palata | — |
Countries
Germany, Turkey, United Kingdom
Contacts
Public ContactGeneral Information
Mitsubishi Tanabe Pharma Europe Ltd (MTPE)
Outcome results
None listed