Condition category
Urological and Genital Diseases
Date applied
01/08/2007
Date assigned
23/08/2007
Last edited
28/08/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Francesco Locatelli

ORCID ID

Contact details

Department of Nephrology and Dialysis
A. Manzoni Hospital
Via dell’Eremo 9/11
Lecco
23900
Italy
f.locatelli@ospedale.lecco.it

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

MPO

Study hypothesis

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

Local and national ethics approvals were obtained for all study sites according to the national legislations.

Study design

Open, prospective, centrally randomised, international, multi-centre study.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Chronic kidney disease stage 5

Intervention

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

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

All-cause mortality, determined upon occurence throughout the complete study period.

Secondary outcome measures

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.

Overall trial start date

15/12/1998

Overall trial end date

15/07/2006

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

666

Participant 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

Recruitment start date

15/12/1998

Recruitment end date

15/07/2006

Locations

Countries of recruitment

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

Trial participating centre

Department of Nephrology and Dialysis
Lecco
23900
Italy

Sponsor information

Organisation

Fresenius Medical Care (Germany)

Sponsor details

Else-Kroener-Strasse 1
Bad Homburg
61352
Germany

Sponsor type

Industry

Website

http://www.fmc-ag.com/

Funders

Funder type

Industry

Funder name

Fresenius Medical Care, for organisational support, monitoring and central laboratoy analysis (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1999 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/10378663
2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/22188691

Publication citations

  1. Protocol

    Locatelli F, Hannedouche T, Jacobson S, La Greca G, Loureiro A, Martin-Malo A, Papadimitriou M, Vanholder R, The effect of membrane permeability on ESRD: design of a prospective randomised multicentre trial., J. Nephrol., 12, 2, 85-88.

  2. Results

    Locatelli F, Cavalli A, Manzoni C, Pontoriero G, The Membrane Permeability Outcome study., Contrib Nephrol, 2011, 175, 81-92, doi: 10.1159/000333816.

Additional files

Editorial Notes