The George Institute For Global Health
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Filtration In the Neuropathy of End Stage kidney disease Symptom Evolution (FINESSE)

Project status: 
Active
FINESSE Statistical Analysis Plan (PDF 540KB)

Many Australians are living with End Stage Kidney Disease receiving life-sustaining haemodialysis therapy. Almost all have evidence of uraemic neuropathy (UN), a condition which can develop to cause nerve-related pain, progressing to weakness and muscle wasting and contributing to disability and poor quality of life.

The FINESSE (Filtration In the Neuropathy of End Stage kidney disease Symptom Evolution) Trial was established to see whether alternative dialysis methods might reduce the incidence and progression of uraemic neuropathy.

In the FINESSE study, 124 participants are randomised to haemodiafiltration versus standard high flux haemodialysis up to 4 years. The primary end-point for this study is the difference in the mean change in total neuropathy score (TNS) from baseline between the two groups. Secondary endpoints include safety outcomes: time to and events of access failure, episodes of septicaemia, cardiovascular events, surgery for carpal tunnel syndrome, parathyroidectomy, fractures requiring or occurring during admission to hospital and mortality.

The FINESSE trial was initiated by Dr Meg Jardine, a kidney disease specialist at Concord Repatriation General Hospital and Deputy Director of the Renal & Metabolic Division of The George Institute. It is overseen by a Steering Committee of physicians with expertise in kidney disease, nerve damage and clinical trials.

Download the FINESSE Statistical Analysis Plan (PDF 540KB).