A feasibility study to inform the design of a national multi-centre RCT to evaluate if reducing serum phosphate to normal levels improves clinical outcomes including mortality, cardiovascular events, bone pain or fracture in patients on dialysis

Central Manchester University Hospitals NHS Trust (CMFT) (UK)0 sites104 target enrollmentJanuary 16, 2014

Overview

Registry

who.int

Start Date

January 16, 2014

End Date

December 31, 2016

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

Central Manchester University Hospitals NHS Trust (CMFT) (UK)

•1\. Male and female patients aged 30 years or above, on dialysis for at least 6 months, under the supervision of Central Manchester University Hospitals Foundation Trust (CMFT) or Salford Royal NHS Foundation Trust (SRFT)
•2\. Serum phosphate level of 1\.8mmol/L or greater after washout (discontinuation) of previous phosphate binding medication
•3\. Able to achieve Renal Association standards for quality of dialysis
•4\. Able to communicate in English ('Communicare' package is available only in English)
•5\. Able to consent

•1\. Living donor renal transplant planned in the next 12 months
•2\. Serum parathyroid hormone greater than 800 pg/ml (85 pmol/L)on 2 consecutive 3\-monthly blood tests. Such patients probably have uncontrolled hyperparathyroidism which adversely influences serum phosphate levels, and needs treatment in its own right
•3\. Known intolerance of oral sevelamer and lanthanum carbonate
•4\. Medical history that might limit the individual's ability to take the trial treatments for the duration of the study (e.g. history of cancer other than non\-melanoma skin cancer, or recent history of alcohol or substance misuse)
•5\. Patients aged below 30 years have a low rate of vascular events and will not be recruited