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

• Conditions: Patients with Chronic Kidney Disease (CKD) not yet on dialysis; MedDRA version: 14.1Level: LLTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 100000004857; Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

• Registration Number: EUCTR2012-004888-41-IT
• Lead Sponsor: AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12-11
• Last Update Posted: 24 February 2014

Recruitment & Eligibility

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

Inclusion Criteria

-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

Exclusion Criteria

-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

Study & Design

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