Clinical trial on the use of d vitamin in haemodialysis patients.

Phase 1

• Conditions: chronic haemodialysis patients; MedDRA version: 14.1Level: HLGTClassification code 10029149Term: NephropathiesSystem Organ Class: 10038359 - Renal and urinary disorders; Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

• Registration Number: EUCTR2011-004984-55-IT
• Lead Sponsor: SOCIETA' ITALIANA DI NEFROLOGIA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-12
• Last Update Posted: 19 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 524

Inclusion Criteria

age >= 18 years; hematic PTH level twofold-ninefold the upper limit; hematic level of 25-OH-D vitamin < 30 ng/ml
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 210
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 314

Exclusion Criteria

renal transplant or peritoneal dialysis less than 3 years ago; pregnancy or breastfeeding

Study & Design

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