Intensive Phosphate Control in Development of Renal End Points and Mortality in CKD (the IPeR Study) - IPeR Study

AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI0 个研究点开始时间: 2012年12月11日最近更新: 2014年2月24日

适应症

试验速览

暂无简介。

•-Patients with CKD not requiring dialysis and with eGFR of 15-60 ml/.min/1.73m2 by using CKD-EPI equation and phosphorus level >3,8 mg/dL
•-Patients have to be aged 18 years or older
•-Patients should be willing and able to provide written informed consent to participate in study
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 175
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 538

•-Patients with current malignancy
•-Women who are pregnant, capable of becoming pregnant and not participating in an acceptable form of birth control
•-Patients with chronic gastrointestinal diseases that could impede their absorptive ability such as Crohn's disease, ulcerative colitis and sprue
•-Patients who have liver insufficiency
•-Patients with a history of solid organ transplantation
•-Patients with a rapid changes of GFR (more than - 5 mL/min within 90 days of enrollment in this study )
•-Patients with PTH > 500 pcg/mL
•-Patients with a persistent hypercalcemia (> 11 mg/dL)
•-Patients in maintenance therapy with phosphate binders
•-Subjects with a non-compliance to dietary and pharmacological prescriptons
•-Subjects who are unable to independently provide written informed consent
•-Subjects with inability to perform a urinary collection of 24 hours
•-Patients with malnutrition (plasma albumin < 3 g/dL)
•-Patients with proteinuria > 2g/24 hours
•-Patients currently participating in a clinical trial with another investigational drug or device or who have receiving an investigational drug or device within 90 days of enrollment in this study

发起方

AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI