AA Amyloidosis trial

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The trial

This is an international randomised multi-centre phase 3 trial looking at whether a novel agent, eprodisate, improves outcome in patients with moderate renal disease and proteinuria.

Brief background on AA amyloidosis

AA amyloidosis may complicate chronic infections or inflammatory diseases.  It is characterised by extracellular deposits of amyloid fibrils composed of fragments of serum amyloid A protein (SAA), an acute phase reactant protein.  The kidney is the most frequent organ involved, with protein leaking into the urine and renal impairment.  Reducing the level of circulating SAA by treating the underlying inflammatory condition is the current treatment but this is not always possible.  Eprodisate competes with molecules that encourage early amyloid fibril formation and an earlier clinical trial suggested that it may slow down progressive renal failure in patients with AA amyloidosis.  This study is designed to see if that can be confirmed in a larger group of patients.

What the trial involves for patients

In order to assess the effects of eprodisate in patients with AA amyloidosis, each patient taking part in the trial is randomly assigned to either:

  • Eprodisate:

tablets taken twice daily

  • Placebo:

tablets taken twice daily

Who can take part in the trial

Patients with confirmed AA amyloidosis with at least 1 g of proteinuria and without severe kidney damage (creatinine clearance greater than 20ml/min).

Outcomes

The primary outcome assessed will be:

  • the number of patients whose kidney function gets worse by more than 40% or who reach end stage kidney failure

Other outcomes assessed (secondary outcomes) will include:

  • change in renal function and urinary protein leak over time
  • overall survival
  • side effects and safety

Timing

This study has been recruiting since 2011.

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