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An Open label study to validate the in vitro performance of LO PS 15 Hemodialyzer reused up to 15 times in patients with End stage Renal Disease on chronic hemodialysis

An Open label study to validate the in vitro performance of LO PS 15 Hemodialyzer reused up to 15 times in patients with End stage Renal Disease on chronic hemodialysis

LOPS15 Trial

General Information
Research Type
Interventional
Description
This was a multi-center, open label single group study designed to validate the performance of LO PS 15 Hemodialyzer reused up to 15 times, using the RenatronĂ’ Dialyzer Reprocessing System with RenalinĂ’ as the sterilant.

12 patients with End stage Renal Disease on chronic hemodialysis from 2 participating sites who met inclusion/exclusion criteria were enrolled into the trial.
A minimum of 50% of the patients should have reused the hemodialyzer 15 times.
Study Information
RMK Priority Area
Research Level
Research Keyword
End stage Renal Disease; dialyzer reprocessing system; in vivo
Inclusion & Exclusion Criteria
Inclusion Criteria
Inclusion criteria:
1. Written informed consent obtained from patient or parents/guardian.
2. Subject age > 18 years
3. On HD for a minimum of 3 months, 2 months of which must have included a history demonstrating reuse of a dialyzer for greater than twelve (12) treatments
4. Free from any currently known unusual clotting or access problems
5. Medically stable
6. Plan to dialyze at participating HD center for at least 4-month duration
7. Hepatitis B surface antigen (HBsAg) negative, documented within the past 30 days, or be Hepatitis B surface antibody (anti-HBs) positive
8. Anti HCV negative, documented within the past 30 days.
9. Anti HIV negative, documented within the past 30 days.
10.Documented dialysis adequacy parameter that has been stable for past 3 months
11. Hematocrit (HCT) between 25 and 40% or a haemoglobin (Hb) not less than 8 g/dL or greater than 13.5 g/dL, as documented within the past 14 days.

Exclusion criteria:
1. Pregnant or nursing woman, or women of childbearing potential without an effective method of birth control. Effective birth control methods are oral contraception, Norplant, surgical sterilization, IUD or diaphragms in conjunction with spermicidal foam and condom on the male partner.
2. Previous plan for extended absences from the participating HD centre
3. Expected to be transplanted (Living related donor) within the study period (4 months)
4. Known allergy or hypersensitivity to Renalin
5. Those persons directly involved in the conduct of the study.
6. History of non-compliance to medical regimen or patients who are unwilling or unable to comply with the protocol.
7. Any serious medical conditions or disability, which in the opinion of the investigator, would interfere with treatment or assessment or preclude completion of this study
Exclusion Criteria
Inclusion criteria:
1. Written informed consent obtained from patient or parents/guardian.
2. Subject age > 18 years
3. On HD for a minimum of 3 months, 2 months of which must have included a history demonstrating reuse of a dialyzer for greater than twelve (12) treatments
4. Free from any currently known unusual clotting or access problems
5. Medically stable
6. Plan to dialyze at participating HD center for at least 4-month duration
7. Hepatitis B surface antigen (HBsAg) negative, documented within the past 30 days, or be Hepatitis B surface antibody (anti-HBs) positive
8. Anti HCV negative, documented within the past 30 days.
9. Anti HIV negative, documented within the past 30 days.
10.Documented dialysis adequacy parameter that has been stable for past 3 months
11. Hematocrit (HCT) between 25 and 40% or a haemoglobin (Hb) not less than 8 g/dL or greater than 13.5 g/dL, as documented within the past 14 days.

Exclusion criteria:
1. Pregnant or nursing woman, or women of childbearing potential without an effective method of birth control. Effective birth control methods are oral contraception, Norplant, surgical sterilization, IUD or diaphragms in conjunction with spermicidal foam and condom on the male partner.
2. Previous plan for extended absences from the participating HD centre
3. Expected to be transplanted (Living related donor) within the study period (4 months)
4. Known allergy or hypersensitivity to Renalin
5. Those persons directly involved in the conduct of the study.
6. History of non-compliance to medical regimen or patients who are unwilling or unable to comply with the protocol.
7. Any serious medical conditions or disability, which in the opinion of the investigator, would interfere with treatment or assessment or preclude completion of this study
Study Timeline
Expected / Actual Date Study Starts - First Enrolment of subject / Collecting data
Aug, 01 2002
Expected / Actual Date Study Completed
Jul, 22 2003
Expected / Actual Duration of Study Enrollment / Data Collection
50 weeks