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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00442819
Other study ID # DMR95-IRB-79
Secondary ID
Status Completed
Phase Phase 4
First received March 1, 2007
Last updated March 1, 2007
Start date July 2006
Est. completion date September 2006

Study information

Verified date March 2007
Source China Medical University Hospital
Contact n/a
Is FDA regulated No
Health authority Taiwan: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date September 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 26 Years to 82 Years
Eligibility 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.

Study Design

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


Related Conditions & MeSH terms


Intervention

Procedure:
Hemodialysis with Polymethylmethacrylate Artificial Kidney


Locations

Country Name City State
Taiwan China Medical University Hospital Taichung

Sponsors (1)

Lead Sponsor Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

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):44 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Improvement of uremic pruritus
Secondary Change of serum level of cytokines
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