Hyperphosphatemia associated with Chronic Kidney Disease (CKD) in patients undergoing hemodialysis. MedDRA version: 17.1 Level: LLT Classification code 10020712 Term: Hyperphosphatemia System Organ Class: 100000004861
Conditions
Interventions
Trade Name: Osvaren 435 mg/235 mg film-coated tablets
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Calcium acetate
CAS Number: 62-54-4
Other descriptive name: CALCIUM ACETATE ANHYDROUS
Conc
Sponsors
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 (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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Italy
Contacts
Public ContactClinical Operations
Sintesi Research Srl
Outcome results
None listed