Small-fiber Neuropathy in Chronic Kidney Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01078857
First received: February 28, 2010
Last updated: March 1, 2010
Last verified: February 2010
  Purpose

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.


Condition Intervention
Small-Fiber Neuropathy
Chronic Kidney Disease
Other: Skin biopsy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Small-fiber Neuropathy in Chronic Kidney Disease

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • The pathology of skin biopsy [ Time Frame: within 3 months after inclusion ] [ Designated as safety issue: No ]
  • Intraepidermal fiber density [ Time Frame: within 3 months after inclusion ] [ Designated as safety issue: No ]
  • Autonomic function [ Time Frame: within 3 months after inclusion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Function of small-fiber sensory nerve [ Time Frame: within 3 months after inclusion ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: February 2009
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Skin biopsy
    A 3-mm-diameter skin biopsy punch was taken at the lateral side of the distal leg and fixed in 4% paraformaldehyde overnight. Sections of 50 m perpendicular to the dermis were cut on a sliding microtome, quenched with 1% H2O2 in methanol, and blocked with 5% normal goat serum. Sections were incubated with rabbit antiserum to protein gene product 9.5 (PGP 9.5, UltraClone, Isle of Wight, UK, 1:1000) overnight. PGP 9.5 is a ubiquitin carboxyl hydrolase, which labels myelinated and unmyelinated nerve fibers in the peripheral nervous system. Sections were then incubated with biotinylated goat anti-rabbit immunoglobulin G (Vector, Burlingame, CA) for 1 h and the avidin-biotin complex (Vector) for another hour. The reaction product was demonstrated using chromogen SG (Vector).
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patients should fulfill the criteria of CKD according to renal function study and the patients of end-stage renal disease should receive regular dialysis therapy and follow-up at outpatient clinics.
  • For disease comparison, patients with peripheral neuropathy of variable etiologies will also be recruited.

Exclusion Criteria:

  • Poor control DM,
  • Severe heart failure,
  • Bleeding tendency,
  • Severe lung disease with respiratory distress,
  • Severe infection,
  • Alcoholism,
  • Amyloidosis,
  • Poor wound healing history.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01078857

Contacts
Contact: Sung-Tsang Hsieh, PhD 886-2-23123456 ext 88182 shsieh@ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 10002
Contact: Sung-Tsang Hsieh, PhD    886-2-23123456 ext 88182    shsieh@ntu.edu.tw   
Principal Investigator: Chi-Chao Chao, MD         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Study Director: Sung-Tsang Hsieh National Taiwan Univeristy Hospital
  More Information

No publications provided

Responsible Party: Chi-Chao, Chao, Department of Neurology, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01078857     History of Changes
Other Study ID Numbers: 200812088R
Study First Received: February 28, 2010
Last Updated: March 1, 2010
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
Chronic kidney disease
Small-fiber neuropathy
Skin biopsy
Contact heat evoked potential
Autonomic neuropathy
Neuropathy in late stage chronic kidney disease

Additional relevant MeSH terms:
Renal Insufficiency, Chronic
Kidney Diseases
Peripheral Nervous System Diseases
Erythromelalgia
Urologic Diseases
Renal Insufficiency
Neuromuscular Diseases
Nervous System Diseases
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 21, 2014