AA Amyloidosis trial

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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.

AA amyloidosis prevention and care for people who inject drugs

Background

People who inject drugs (PWID) often suffer from severe chronic skin and soft tissue infections, which is a risk factor for developing AA amyloidosis.  These patients are often diagnosed and referred to the NAC at a late disease when renal failure is already advanced.  They often experience profound difficulty in adhering to dialysis treatment and median survival once dialysis has ensued is 19 months in the PWID population, compared to 52 months for all patients with AA amyloidosis on haemodialysis in the UK.

Prevalence of AA amyloidosis amongst PWID in the UK is unknown.  Screening for AA amyloidosis involves a simple dipstick test for protein in the urine, but UK drug treatment services do not provide routine AA amyloidosis risk screening or early intervention.

The trial

Researchers at the London School of Hygiene & Tropical Medicine, in collaboration with the National Amyloidosis Centre, designed this trial in order to investigate several issues relating to AA amyloidosis amongst PWID, including the feasibility of screening for AA amyloidosis in drug treatment services.

What the trial involves for patients

The researchers aim to recruit at least 400 PWID from five London drug treatment services to:

  • complete a questionnaire assessing AA amyloidosis risk factors
  • provide a urine sample to be screened for proteinuria

All participants with confirmed proteinuria will be referred to the NAC where they will be assessed for AA amyloidosis.

Who can take part in the trial

PWID attending five London drug treatment services.

Objectives

This is a mixed methods multi-phase study with 6 interlinked objectives:

  1. To review and assess the existing evidence for AA amyloidosis among PWID. (Phase 1)
  2. To test the feasibility of screening for AA-amyloidosis in drug treatment services. (Phase 2)
  3. To estimate the prevalence of SSTI and AA-amyloidosis among UK PWID. (Phase 2)
  4. To identify barriers and facilitators to the AA-amyloidosis care pathway for PWID. (Phase 3)
  5. To understand the factors informing SSTI risk, protection and care among PWID. (Phase 4)
  6. To develop SSTI and AA-amyloidosis information resources through partnership with affected communities. (Phase 5)

Timing

This study is due to open in late 2017.

 

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