Condition category
Nutritional, Metabolic, Endocrine
Date applied
29/03/2006
Date assigned
27/04/2006
Last edited
31/05/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.profilstudy.org

Contact information

Type

Scientific

Primary contact

Prof Anders Alvestrand

ORCID ID

Contact details

Department of Clinical Science
Intervention and Technology
Karolinska Institutet
Stockholm
S 141 86
Sweden
+46 (0)858582656
anders.alvestrand@klinvet.ki.se

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

PROFIL

Study hypothesis

As compared with hemodialysis (HD), on-line, predilution hemofiltration (HF) reduces the development of left ventricular hypertrophy (LVH), decreases overall morbidity, and retards the loss of residual renal function in incident dialysis patients

Ethics approval

Approved by the Karolinska Institute Ethics Review Board 29/12/1999, reference number: 99-292

Study design

Prospective, randomised, controlled, parallel group design

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

End stage renal disease patients starting dialysis treatment

Intervention

Two different modes of dialysis, conventional hemodialysis (HD) versus hemofiltration (HF)

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The objective of this study is to compare the effect of treatment with pre-dilution HF and HD, respectively, on left ventricular mass index (LVMI) during 1 to a maximum of 3 years follow up

Secondary outcome measures

To compare the effect of HF and HD with respect to:
1. Mortality (all causes)
2. Hospitalisation (number of occasions, total number of days in hospital)
3. Blood pressure (antihypertensive drug index)
4. Dose of recombinant human erythropoietin (rHuEPO) needed to keep hemoglobin at target level
5. Infections (antibiotic drug index)
6. Serum lipids
7. Patients’ subjective evaluation of intra- and inter-dialytic symptoms
8. Residual renal function
9. Cost effectiveness

Overall trial start date

15/05/2000

Overall trial end date

28/02/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male and female patients with chronic renal failure
2. Age ≥20 and ≤80 years
3. Dialysis treatment <3 months
4. Expected time in HD at treatment site >1 year

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

48

Participant exclusion criteria

1. History of myocardial infarction within 3 months
2. Unstable angina
3. Severe cardiac valvular disease
4. Severe cardiac failure (New York Heart Association [NYHA] III-IV)
5. Disseminated malignancy
6. Expected time in hemodialysis <1 year
7. Participation in another study, which may interfere with the present study
8. Unwillingness to undergo the investigations and follow-up required in the protocol
9. Access to the circulation by central venous catheter >3 months
10. Body weight ≥100 kg

Recruitment start date

15/05/2000

Recruitment end date

28/02/2006

Locations

Countries of recruitment

Denmark, Sweden

Trial participating centre

Department of Clinical Science
Stockholm
S 141 86
Sweden

Sponsor information

Organisation

Gambro Corporate Research (Sweden)

Sponsor details

c/o Ingrid Ledebo
Gambro Corporate Research
Box 10101
Lund
S-220 10
Sweden
+46 (0)46 16 91 76
ingrid.ledebo@gambro.com

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Study monitor provided by Gambro Corporate Research; financial support to participating clinics in relation to patient enrollment came from Gambro Svenska Försäljnings AB

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

2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21252503

Publication citations

  1. Results

    Alvestrand A, Ledebo I, Hagerman I, Wingren K, Mattsson E, Qureshi AR, Gutierrez A, Left ventricular hypertrophy in incident dialysis patients randomized to treatment with hemofiltration or hemodialysis: results from the ProFil study., Blood Purif., 2011, 32, 1, 21-29, doi: 10.1159/000323140.

Additional files

Editorial Notes