Pharma-economic comparison regarding the use of medicines to control the levels of Phosphate in the blood in patients suffering from Chronic Kidney Disease associated with mineral and bone disorder.

• Conditions: Hyperphosphatemia associated with Chronic Kidney Disease (CKD) in patients undergoing hemodialysis.; MedDRA version: 17.1Level: LLTClassification code 10020712Term: HyperphosphatemiaSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2014-004340-35-IT
• Lead Sponsor: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12-16
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Male and female patients with Chronic Kidney Disease (CKD5D) in HD treatment with scheduled three sessions/week since at least three months / Age >18 years old / Serum Phosphate >5.5 mg/dl without P binders prescription OR serum Phosphate >5,5 mg/dl at the end of first wash-out week, if P binders were prescribed OR serum Phosphate >5,5 mg/dl at the end of second wash-out week, in case serum P values are not >5,5 mg/dl at the end of first wash-out week, if P binders were prescribed OR patients previously selected for the enrollment if Serum Phosphate >5,5 mg/dl after the second wash-out week, at any time during the six months after the first patient being enrolled at the center / If the patient is a female of childbearing potential, she is using an acceptable method of contraception during the study period.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 160

Exclusion Criteria

Severe hyperphosphatemia despite the use of P binders (serum P >8 mg/dl) / Severe hyperparathyroidism (defined as PTH levels >9 times superior to normal level, by definition of KDIGO guidelines) according to Patient’s Medical History / PTH levels excessively suppressed (< 100 pg/mL) according to Patient’s Medical History / Patients treated with Aluminum-containing P binders / Persistent or recurrent hypercalcemia with total Calcium levels, corrected for albumin, >10 mg/dl, according to Patient’s Medical History / Poor compliance, upon Investigator’s opinion / Inadequate dialysis at screening (Kt/V< 1.2 or URR< 65%) / Oral anticoagulants intake / Malignancy with survival perspective <1 year / Active autoimmune diseases treated with steroids / Pregnancy at time of enrolment / Refusal of consent to participate / Contraindications or hypersensitivity to the Investigational Product (elevated sMg levels of more than 2 mmol/l (4,85 mg/dl), and/or symptoms of hypermagnesaemia / AV-block III° / Myasthenia gravis).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of Osvaren in maintaining serum phosphate levels <5.5 mg / dl, reaching an optimal level of 4.5 mg / dl, in comparison with Calcium carbonate, with a potential sparing effect on the use of Calcium-free Phosphate binders through their delayed introduction in the therapy.;Secondary Objective: To evaluate the progression of vascular calcifications and the occurrence of vertebral fractures in patients treated.;Primary end point(s): Time lag (days) from the start of the study (week 0) to the day of possible introduction of a Calcium/Aluminum-free Phosphate binder (Sevelamer / Lanthanum carbonate). This will be translated into a pharma-economic difference in the cost of treatment, taking into account the drug and dose used in the individual patient.;Timepoint(s) of evaluation of this end point: Evaluations during the whole study period.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1) Progression of abdominal aorta vascular calcifications, through Kauppila scoring system / 2) Characterization of vertebral fractures, through quantitative vertebral morphometry / 3) Measurement of optimal serum Magnesium concentration (safety outcome).;Timepoint(s) of evaluation of this end point: 1) Baseline vs Half vs End of treatment period / 2) Baseline vs Half vs End of treatment period / 3) Evaluations during the whole study period.