The effect of Membrane Permeability on End-Stage Renal Disease (ESRD) patient Outcome

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN43474447

Enrollment

666

Registered

2007-08-23

Start date

1998-12-15

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic kidney disease stage 5 Urological and Genital Diseases Chronic kidney disease stage 5

Interventions

Chronic hemodialysis with high-flux membranes vs low-flux membranes.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age between 18 and 80 years old 2. Up to two months on renal replacement therapy

Exclusion criteria

Exclusion criteria: 1. Scheduled for renal transplantation from a living donor within the period of the study 2. On hemodialysis after renal transplantation 3. Serious clinical conditions: 3.1. Nephrotic syndrome 3.2. Active malignancies 3.3. Current therapy with immunosuppressive agents 3.4. Severe congestive heart failure despite maximal therapy (New York Heart Association [NYHA] class IV) 3.5. Unstable angina pectoris 3.6. Active systemic infections (i.e. tuberculosis, systemic fungal infection, AIDS, hepatitis) 3.7. Chronic pulmonary disease requiring supplementary oxygen 3.8. Cirrhosis with encephalopathy

Design outcomes

Primary

Measure	Time frame
All-cause mortality, determined upon occurence throughout the complete study period.	—

Secondary

Measure	Time frame
1. Mortality due to infections 2. Mortality due to cardiovascular causes 3. Morbidity due to all causes 4. Morbidity due to infections 5. Morbidity due to problems related to vascular access 6. Pre-dialysis beta2-microglobulin levels 7. Pre-dialysis plasma levels of Advanced Glycosylation End-products (AGE) 8. Hematocrit levels and related rHu-EPO dose 9. Triglycerides and the High Density Lipoproteins (HDL) / Low Density Lipoprotein (LDL) cholesterol ratio 10. Pre-dialysis bicarbonate 11. Nutritional parameters 12. Protein Catabolic Rate (PCR) 13. Residual renal function 1 to 5 above were determined upon occurence throughout the complete study period, and the other parameters in 6-monthly intervals.	—

Measure

Time frame

1. Mortality due to infections 2. Mortality due to cardiovascular causes 3. Morbidity due to all causes 4. Morbidity due to infections 5. Morbidity due to problems related to vascular access 6. Pre-dialysis beta2-microglobulin levels 7. Pre-dialysis plasma levels of Advanced Glycosylation End-products (AGE) 8. Hematocrit levels and related rHu-EPO dose 9. Triglycerides and the High Density Lipoproteins (HDL) / Low Density Lipoprotein (LDL) cholesterol ratio 10. Pre-dialysis bicarbonate 11. Nutritional parameters 12. Protein Catabolic Rate (PCR) 13. Residual renal function 1 to 5 above were determined upon occurence throughout the complete study period, and the other parameters in 6-monthly intervals.

—

Countries

Belgium, France, Germany, Greece, Italy, Poland, Portugal, Spain, Sweden

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026