Uremic Pruritus, Cytokines and Polymethylmethacrylate Artificial Kidney - Full Text View

Sponsored by:	China Medical University Hospital
Information provided by:	China Medical University Hospital
ClinicalTrials.gov Identifier:	NCT00442819

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 IV

MedlinePlus related topics: Dialysis Itching Kidney Failure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

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

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 of Results:

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.

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

Keywords provided by China Medical University Hospital:

Uremic Pruritus
Cytokines
Polymethylmethacrylate Artificial Kidney
Hemodialysis

Study placed in the following topic categories:

Polymethyl Methacrylate
Pruritus
Signs and Symptoms
Skin Diseases
Uremia

Additional relevant MeSH terms:

Skin Manifestations
Vasodilator Agents
Therapeutic Uses
Physiological Effects of Drugs

Antimutagenic Agents
Cardiovascular Agents
Protective Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009