UremiaPhase 4NCT00442819
Uremic Pruritus, Cytokines and Polymethylmethacrylate Artificial Kidney
A Phase 4 study testing Hemodialysis with Polymethylmethacrylate Artificial Kidney in people with Uremia and Pruritus, run by China Medical University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 26 to 82 years
- What is being tested?
- Hemodialysis with Polymethylmethacrylate Artificial Kidney
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2006to Sep 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 26 to 82 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Pruritus unrelated to renal failure
- Evidence of malignancy
- Liver cirrhosis diagnosed by echogram or admission within 3 months of the start of the study.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Hemodialysis with Polymethylmethacrylate Artificial Kidney
- Keywords
- Uremic Pruritus, Cytokines, Polymethylmethacrylate Artificial Kidney, Hemodialysis
- Medical subject headings
- Uremia, Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemodialysis with Polymethylmethacrylate Artificial KidneyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of uremic pruritus
Secondary outcomes (1)
Change of serum level of cytokines
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2007 (estimated)
- Study startJul 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for UremiaStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Chiu-Ching Huang, MD, Study director, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00442819
- Sponsor's protocol ID
- DMR95-IRB-79
- Status last verified
- Mar 2007
- First submitted
- 1 Mar 2007
- Last updated
- 2 Mar 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 11453873
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uremic Pruritus, Cytokines and Polymethylmethacrylate Artificial Kidney
- ClinicalTrials.gov ID
- NCT00442819
- Acronym / sponsor ID
- DMR95-IRB-79
- Keywords
- Uremic Pruritus, Cytokines, Polymethylmethacrylate Artificial Kidney, Hemodialysis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- Jul 2006
- Study completion
- Sep 2006
- First posted
- 2 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 26 to 82 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- Pruritus unrelated to renal failure
- Evidence of malignancy
- Liver cirrhosis diagnosed by echogram or admission within 3 months of the start of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hemodialysis with Polymethylmethacrylate Artificial Kidney | Procedure or surgery | – |
Primary outcome
Improvement of uremic pruritus
1 secondary outcome
Change of serum level of cytokines
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2007.
- Results publication: PubMed 11453873Kato 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chiu-Ching Huang, MD study director
China Medical University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hemodialysis with Polymethylmethacrylate Artificial Kidney in people with Uremia and Pruritus, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of uremic pruritus. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00442819, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2007.