Randomized controlled trial of two different combinations of Calcium-containing Phosphate binders (Ca-PiB) plus non-Calcium-non-Aluminum containing Phosphate binders (no-Ca-Al-PiB): a pharma-economic approach. - OSvaren vs CAlcium carbonate Research - OSCAR

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico0 个研究点开始时间: 2014年12月16日最近更新: 2015年8月4日

适应症

试验速览

暂无简介。

•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

•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).

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