The effect of Membrane Permeability on End-Stage Renal Disease (ESRD) patient Outcome
| ISRCTN | ISRCTN43474447 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43474447 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Department of Nephrology and Dialysis
A. Manzoni Hospital
Via dellEremo 9/11
Lecco
23900
Italy
| f.locatelli@ospedale.lecco.it |
Study information
| Study design | Open, prospective, centrally randomised, international, multi-centre study. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 | 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 study start date | 15/12/1998 |
| Completion date | 15/07/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
23900
Italy
Sponsor information
Fresenius Medical Care (Germany)
Industry
Industry
Else-Kroener-Strasse 1
Bad Homburg
61352
Germany
| Website | http://www.fmc-ag.com/ |
|---|---|
"ROR" |
https://ror.org/04sk0bj73 |
Funders
Funder type
Industry
Fresenius Medical Care, for organisational support, monitoring and central laboratoy analysis (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/03/1999 | Yes | No | |
| Results article | results | 01/07/2011 | Yes | No |
