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

ISRCTN	ISRCTN43474447
DOI	https://doi.org/10.1186/ISRCTN43474447
Protocol serial number	N/A
Sponsor	Fresenius Medical Care (Germany)
Funder	Fresenius Medical Care, for organisational support, monitoring and central laboratoy analysis (Germany)

Submission date: 01/08/2007
Registration date: 23/08/2007
Last edited: 28/08/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Francesco Locatelli
Scientific

Department of Nephrology and Dialysis
A. Manzoni Hospital
Via dellEremo 9/11
Lecco
23900
Italy

Email	f.locatelli@ospedale.lecco.it

Study information

Primary study design	Interventional
Study design	Open, prospective, centrally randomised, international, multi-centre study.
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	MPO
Study objectives	To test whether the survival of ESRD patients treated with bicarbonate hemodialysis using high-flux membranes is better than that of those treated with bicarbonate hemodialysis using low-flux membranes. This trial is also registered with the Cochrane Renal Group Registry (registration number: CRG 090500013).
Ethics approval(s)	Local and national ethics approvals were obtained for all study sites according to the national legislations.
Health condition(s) or problem(s) studied	Chronic kidney disease stage 5
Intervention	Chronic hemodialysis with high-flux membranes vs low-flux membranes.
Intervention type	Other
Primary outcome measure(s)	All-cause mortality, determined upon occurence throughout the complete study period.
Key secondary outcome measure(s)	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.
Completion date	15/07/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	666
Key inclusion criteria	1. Age between 18 and 80 years old 2. Up to two months on renal replacement therapy
Key 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
Date of first enrolment	15/12/1998
Date of final enrolment	15/07/2006

Locations

Countries of recruitment

Belgium
France
Germany
Greece
Italy
Poland
Portugal
Spain
Sweden

Study participating centre

Department of Nephrology and Dialysis

Lecco
23900
Italy

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2011		Yes	No
Protocol article	protocol	01/03/1999		Yes	No