Survival Improvement with Cholecalciferol in Patients on Dialysis – The SIMPLIFIED Registry Trial

Phase 1

Conditions: Kidney Failure (requiring dialysis).
MedDRA version: 20.0Level: LLTClassification code 10023420Term: Kidney failure chronicSystem Organ Class: 100000070575
Therapeutic area: Body processes [G] - Physiological processes [G07]

Registration Number: EUCTR2015-005003-88-GB

Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust and University of Cambridge

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 4200

Inclusion Criteria

•Have given written informed consent to participate
•Age 18 years or over
•UK Resident
•Have dialysis-requiring End Stage Renal Disease

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 2100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2100

Exclusion Criteria

•Current treatment with high dose (>1,000IU/day) cholecalciferol
•Women who are pregnant / planning to become pregnant or are breastfeeding
•Persistent hypercalcaemia (>2.62 mmol/l on three separate occasions without precipitating cause
•Life expectancy < 6 months
•Not contributing, or willing to contribute, data to the UK Renal Registry
•Inability to provide informed consent

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the effectiveness of cholecalciferol (inactive vitamin D) taken at a dose of 60,000 International Units (IU) fortnightly in improving survival of patients with kidney disease who require dialysis.;Secondary Objective: To determine the effect of cholecalciferol (inactive vitamin D) taken at a dose of 60,000 International Units (IU) fortnightly on quality of life and secondary clinical outcomes in patients with kidney disease who require dialysis.;Primary end point(s): All-cause mortality (death). SIMPLIFIED is powered to detect a 13% reduction in all-cause mortality. Data will be obtained via the Office of National Statistics. Assessment of the primary endpoint will require 2200 events.;Timepoint(s) of evaluation of this end point: The endpoint will be evaluated once 2200 events are confirmed.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Health Related Quality of Life (via questionnaire)<br>•Cardiovascular events <br>•Admission requiring infections<br>•Cancer<br>•Admission requiring fractures;Timepoint(s) of evaluation of this end point: The endpoint will be evaluated once 2200 events are confirmed for the primary outcome measure.