Uremic Pruritus, Cytokines and Polymethylmethacrylate Artificial Kidney

This study has been completed.
Sponsor:
Information provided by:
China Medical University Hospital
ClinicalTrials.gov Identifier:
NCT00442819
First received: March 1, 2007
Last updated: NA
Last verified: March 2007
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Uremia
Pruritus
Procedure: Hemodialysis with Polymethylmethacrylate Artificial Kidney
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by China Medical University Hospital:

Primary Outcome Measures:
  • Improvement of uremic pruritus

Secondary Outcome Measures:
  • Change of serum level of cytokines

Estimated Enrollment: 30
Study Start Date: July 2006
Estimated Study Completion Date: September 2006
  Eligibility

Ages Eligible for Study:   26 Years to 82 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00442819

Locations
Taiwan
China Medical University Hospital
Taichung, Taiwan, 404
Sponsors and Collaborators
China Medical University Hospital
Investigators
Study Director: Chiu-Ching Huang, MD China Medical University Hospital
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00442819     History of Changes
Other Study ID Numbers: DMR95-IRB-79
Study First Received: March 1, 2007
Last Updated: March 1, 2007
Health Authority: Taiwan: Institutional Review Board

Keywords provided by China Medical University Hospital:
Uremic Pruritus
Cytokines
Polymethylmethacrylate Artificial Kidney
Hemodialysis

Additional relevant MeSH terms:
Pruritus
Skin Diseases
Skin Manifestations
Signs and Symptoms
Polymethyl Methacrylate
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antimutagenic Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 16, 2014