Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00029

2 Trial Registration Date

2005-09-13

i Registration Status

Retrospective

3 Secondary IDs

4 Source(s) of Funding

CUHK

5 Primary Sponsor

CUHK

6 Secondary Sponsor

N/A

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Cheng Yuk Lun

ii Address

iii Phone

iv Email

email chengyl1@ha.org.hk

v Affiliation

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Cheng Yuk Lun

ii Address

iii Phone

iv Email

email chengyl1@ha.org.hk

v Affiliation

vi Country

9 Official Scientific Title of the Study

Effect of Haemdialysis Membrane Permeability on Inflammatory Indices and Arterial Stiffness: A Comparison between 2 Dialyzers Composing of Identical Material but with Different Flux Characterics.

10 Public Title

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

Effect of dialysis flux on inflammatory indices and arterial stiffness

12 Countries of Recruitment

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2004-12-14

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Heart and Blood Vessel Diseases

15 Intervention

i Types of intervention

Device

Please specify

ii Description/ name of Intervention/article

The recruited patients will be put on 24 weeks of haemodialysis with high-flux dialyzer. Patients will otherwise be dialyzed with their usual prescriptions.

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

24 weeks

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

The recruited patients will be put on 24 weeks of haemodialysis with low-flux dialyzer.

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Inclusion criteria: 1. Anuric (urine output < 100 ml/day). 2. Age between 18 and 75 years old. 3. On hemodialysis treatment with bicarbonate dialysate, for at least 3 months. 4. On a dialyzer reuse program using polysulfone dialyzer for at least 3 months. 5. Stable with no change in dialysis prescription for at least 3 months preceding enrolment. 6. Vascular access functioning properly. 7. Informed consent.

ii Exclusion Criteria

Exclusion criteria: 1. Contraindication for dialyzer reuse. 2. Active infection, inflammatory disease, ongoing malignancy or active phase immune disease. 3. Patient with immunosuppressive medication. 4. Recently measured C-reactive protein level > 50 mg/L. 5. Predictable survival < 1 year. 6. Planned renal transplantation within the 1-year study period.

iii Age Minimum

iv Age Maximum

v Gender

18 Study Type

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Active

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Crossover

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2005-03-01

21 Target Sample Size

40

22 Recruitment Status

Recruiting

23 Primary Outcome

Comparing the arterial pulse wave velocity and the inflammatory indices between the 2 groups.

24 Secondary Outcome

Comparing the biochemical markers between the 2 groups.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2009-11-27

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

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Trial History Detail on 2009-11-19