Uremic Pruritus, Cytokines and Polymethylmethacrylate Artificial Kidney
Primary Purpose
Uremia, Pruritus
Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Hemodialysis with Polymethylmethacrylate Artificial Kidney
Sponsored by
About this trial
This is an interventional treatment trial for Uremia focused on measuring Uremic Pruritus, Cytokines, Polymethylmethacrylate Artificial Kidney, Hemodialysis
Eligibility 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.
Sites / Locations
- China Medical University Hospital
Outcomes
Primary Outcome Measures
Improvement of uremic pruritus
Secondary Outcome Measures
Change of serum level of cytokines
Full Information
NCT ID
NCT00442819
First Posted
March 1, 2007
Last Updated
March 1, 2007
Sponsor
China Medical University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00442819
Brief Title
Uremic Pruritus, Cytokines and Polymethylmethacrylate Artificial Kidney
Study Type
Interventional
2. Study Status
Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
China Medical University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uremia, Pruritus
Keywords
Uremic Pruritus, Cytokines, Polymethylmethacrylate Artificial Kidney, Hemodialysis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Hemodialysis with Polymethylmethacrylate Artificial Kidney
Primary Outcome Measure Information:
Title
Improvement of uremic pruritus
Secondary Outcome Measure Information:
Title
Change of serum level of cytokines
10. Eligibility
Sex
All
Minimum Age & Unit of Time
26 Years
Maximum Age & Unit of Time
82 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chiu-Ching Huang, MD
Organizational Affiliation
China Medical University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
11453873
Citation
Kato A, Takita T, Furuhashi M, Takahashi T, Watanabe T, Maruyama Y, Hishida A. Polymethylmethacrylate efficacy in reduction of renal itching in hemodialysis patients: crossover study and role of tumor necrosis factor-alpha. Artif Organs. 2001 Jun;25(6):441-7. doi: 10.1046/j.1525-1594.2001.025006441.x.
Results Reference
result
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Uremic Pruritus, Cytokines and Polymethylmethacrylate Artificial Kidney
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