Uremic Pruritus, Cytokines and Polymethylmethacrylate Artificial Kidney

Background: Uremic pruritus is one of the common complications in long-term dialysis patients. In general, many factors including xerosis, elevated serum calcium, phosphate, calcium-phosphate product, hyperparathyroidism and inadequate dialysis may contribute to it. Recently, researchers reported that immuno-hypothesis with high serum level of cytokines could be the cause of uremic pruritus. Polymethylmethacrylate (PMMA) artificial kidney (AK) has been reported to adsorb more serum cytokines than other high flux artificial kidneys.

Methods: In July 2006, 30 patients with severe uremic pruritus from 300 chronic hemodialysis patients in a single center entered this prospective study. Their dialyzers were changed to PMMA AK for 4 weeks. The severity of pruritus was evaluated every week using the results of a questionnaire (pruritus score). Laboratory assays including pre-dialysis serum blood urea nitrogen, creatinine, β2-microgblubulin (β2M), calcium, phosphate, intact parathyroid hormone (iPTH), total CO2, ferritin, hematocrit, high sensitivity C-reactive protein (hsCRP), IL-1, IL-2, IL-6, IL-18, TNF-α, KT/V and β2M clearance were measured before and at the end of 4 weeks of PMMA AK use.

Expected Results:To prove the PMMA membrane could improve the uremic pruritus and to reveal the effect of PMMA membrane on serum level of possible factors contributing to uremic pruritus.

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Key information

Conditions

Uremia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Pruritus Signs and Symptoms Skin Diseases Skin Manifestations Skin and Connective Tissue Diseases Urogenital Diseases Urologic Diseases

Age range

26 year–82 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

China Medical University Hospital

Taichung, 404, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with chronic pruritus (>3 months) were screened using traditional visual analogue scale (VAS) and then scored using a pruritus questionnaire (pruritus scoring system).
Other inclusion criteria were that patients enrolled should be dialysed for 4 hours, three times a week, with KT/V >1.2, serum albumin> 3.0 mg/dl, hematocrit > 24%, ferritin < 900 ng/ml, phosphate <7 mg/dl, corrected calcium <11 mg/dl, calcium-phosphate product < 70, intact parathyroid hormone (iPTH) <600 pg/ml, and normal serum level of alanine aminotransferase and bilirubin in past 3 months.

Exclusion criteria

Pruritus unrelated to renal failure
Evidence of malignancy
Liver cirrhosis diagnosed by echogram or admission within 3 months of the start of the study.

Treatment and study plan

Hemodialysis with Polymethylmethacrylate Artificial Kidney

Procedure

Primary outcomes

Improvement of uremic pruritus

Secondary outcomes

Change of serum level of cytokines

Sponsors and collaborators

Lead sponsor

China Medical University Hospital

Other

Registry information

Important dates

Study start: 2006
Study completion: 2006
First posted: Mar 2, 2007
Registry last updated: Mar 2, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed