NCT01078857

Small-fiber Neuropathy in Chronic Kidney Disease

Status unknown NA Last updated 1 March 2010

What this trial tests

NA trial testing Skin biopsy in Small-Fiber Neuropathy in 120 participants. Status unknown.

Timeline

1 February 2009

Primary endpoint
1 August 2012

Quick facts

Lead sponsor	National Taiwan University Hospital
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	120
Start date	1 February 2009
Primary completion	1 August 2012
Sites	1 location across Taiwan

Drugs / interventions tested

• Skin biopsy

Conditions studied

• Small-Fiber Neuropathy — all drugs for Small-Fiber Neuropathy →
• Chronic Kidney Disease — all drugs for Chronic Kidney Disease →

Sponsor

National Taiwan University Hospital

Who can join

18 and older, any sex, with Small-Fiber Neuropathy or Chronic Kidney Disease. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• The pathology of skin biopsy
  Time frame: within 3 months after inclusion
• Intraepidermal fiber density
  Time frame: within 3 months after inclusion
• Autonomic function
  Time frame: within 3 months after inclusion

Sponsor's own description

Neurological dysfunction is a common complication of late stage chronic kidney disease (CKD) and peripheral nerve system is often involved in such complication. Sensory disturbances such as paresthesia and hypoesthesia are the predominant symptoms in uremic polyneuropathy and it is traditionally thought the uremic polyneuropathy mainly involve large-diameter sensory nerves. However in uremic patients the abnormal thermal thresholds, the sensory symptoms like numbness, burning, paradoxical heat, cold or freezing, and pain, and the frequent symptoms of autonomic dysfunction suggest that small-fiber neuropathy should be a clinical entity in patients of CKD. But there are still few investigations with emphasis on the changes of small-fiber nerves in CKD, and little is known about the characteristics and mechanism of small-fiber neuropathy in CKD. Skin biopsy with evaluation of epidermal nerve density and the morphology of epidermal nerves and the subepidermal nerve plexus is an effective and minimally invasive test for assessment of small-fiber neuropathy. Contact heat evoked potential (CHEP) recording the brain responses evoked by contact heat stimuli on the skin is a non-invasive technique to investigate the thermo-nociceptive pathways mediated by small-fiber nerves. In the current study, we will use an integrated approach by combining the skin biopsy, quantitative sensory testing, autonomic function tests, and CHEP to investigate the pathological, psychophysical and physiological aspects of small-fiber neuropathy in patients of CKD. The aims of the current study is to address the following issues: (1) the changes of small fiber nerves in uremia and CKD of different stage; (2) the correlation of skin innervation with clinical manifestations, thermal thresholds, and autonomic function; (3) the influence of dialysis therapy, the type of dialysis therapy, or renal transplantation on the small fiber neuropathy in uremia; (4) the roles of blood chemical substances, metals, and endocrine profiles on the development of small-fiber neuropathy; (5) the relationship between the small-fiber neuropathy and pruritus or restless leg syndrome; and (6) the pathological and physiological correlates of painful symptoms by skin biopsy and CHEP in CKD related neuropathy. The results of the study will provide important insights in the understanding of the pathogenesis, and the prevention and new treatments of small-fiber neuropathy in CKD.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.