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

11 Chuen On Road, Tai Po, N.T. Hong Kong, China

iii Phone

852-2689 3023

iv Email

chengyl1@ha.org.hk

v Affiliation

Dept. of Medicine, Alice Ho Miu Ling Nethersole Hospital

vi Country

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

i Name

Cheng Yuk Lun

ii Address

11 Chuen On Road, Tai Po, N.T. Hong Kong, China

iii Phone

852-2689 3023

iv Email

chengyl1@ha.org.hk

v Affiliation

Dept. of Medicine, Alice Ho Miu Ling Nethersole Hospital

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

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.

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

Hong Kong, China

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

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

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

18

iv Age Maximum

75

v Gender

Both Male and Female

18 Study Type

Interventional

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

Complete

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 2009-11-27