Small-fiber Neuropathy in Chronic Kidney Disease

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01078857
Study type	Interventional
Source	National Taiwan University Hospital
Contact	Sung-Tsang Hsieh, PhD
Phone	886-2-23123456
Email	shsieh@ntu.edu.tw
Status	Recruiting
Phase	N/A
Start date	February 2009

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05491642` - A Study in Male and Female Participants (After Menopause) With Mild to Moderate High Blood Pressure to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body and How it Moves Into, Through and Out of the Body After Taking Single and Multiple Doses	Phase 1
Recruiting	`NCT06363097` - Urinary Uromodulin, Dietary Sodium Intake and Ambulatory Blood Pressure in Patients With Chronic Kidney Disease
Terminated	`NCT04043026` - The Effects of Renal Function and Atrial Fibrillation on Lipoproteins and Clot Structure/Function
Completed	`NCT05318014` - Low-protein Formula Supplements in Chronic Kidney Disease	N/A
Active, not recruiting	`NCT06071065` - Clinical Pharmacist Intervention on Medication Adherence and Clinical Outcomes in Chronic Kidney Disease Patients	N/A
Completed	`NCT02878317` - Skin Autofluorescence as a Risk Marker in People Receiving Dialysis.
Not yet recruiting	`NCT06039254` - Safety and Pharmacokinetics of HRS-1780 in Healthy Subjects and Subjects With Impaired Renal Function	Phase 1
Recruiting	`NCT03160326` - The QUALITY Vets Project: Muscle Quality and Kidney Disease
Withdrawn	`NCT02885545` - The Strategy to Prevent Hemorrhage Associated With Anticoagulation in Renal Disease Management (STOP HARM) Trial	Phase 4
Completed	`NCT02875886` - DD-study: Diet or Diuretics for Salt-sensitivity in Chronic Kidney Disease	Phase 4
Completed	`NCT02888171` - Impact of Ferric Citrate vs Ferrous Sulfate on Iron Parameters and Hemoglobin in Individuals With CKD and Iron Deficiency	N/A
Completed	`NCT02896309` - The Effect of Correction of Metabolic Acidosis in CKD on Intrarenal RAS Activity	N/A
Completed	`NCT02756520` - Observational Study on CKD Treatment With a Ketosteril Supplemented Protein-restricted Diet (Keto-024-CNI)
Completed	`NCT02836574` - A Study of Renal Autologous Cell Therapy (REACT) in Type 2 Diabetics With Chronic Kidney Disease	Phase 2
Active, not recruiting	`NCT02483039` - Nephrologist Follow-up Versus Usual Care After an Acute Kidney Injury Hospitalization	N/A
Completed	`NCT02369549` - Micro-Particle Curcumin for the Treatment of Chronic Kidney Disease	Phase 3
Terminated	`NCT02543177` - Optimised Procedure in Patients With NSTEMI and CKD	N/A
Completed	`NCT02992548` - Effect of Pravastatin on Erythrocyte Membrane Fatty Acid Contents in Patients With Chronic Kidney Disease	Phase 4
Recruiting	`NCT02205944` - Impact of Presurgical Exercise on Hemodialysis Fistula Outcomes	N/A
Active, not recruiting	`NCT02231138` - Efficacy and Safety of Abelmoschus Manihot for Chronic Kidney Disease	Phase 4