Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
GAMBRO 99/03
Study information
Scientific title
Acronym
Hemodiafiltation (HDF) optimisation
Study hypothesis
The aim of the study is to show if highly efficient and more frequent dialysis treatment is able to improve removal of low and high molecular weight uremic toxins. Clinical data on elimination and rebound kinetics of uremic toxins in a broad range of molecular weight should serve as the basis for the adjustment of kinetic models of solute removal during hemodiafiltraion treatments. These models should allow for an optimisation of hemodiafiltration treatment parameters.
Ethics approval
Approved on 18 October 1999 by the the Freiburg Ethics Commission International (FECI)
Study design
Four-period crossover
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
Intervention
Modification of treatment mode, frequency, drawing and analysis of blood samples
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Blood concentrations of small and large molecular weight uremic solutes
Secondary outcome measures
Modelling of solute kinetics
Overall trial start date
01/01/2000
Overall trial end date
30/06/2000
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Stable patients with renal end stage disease being on hemodialysis for at least six months
2. Residual urine volume less than 200 ml per day
3. Ages betweeen 18 and 75 years
4. Body dry weight between 60 and 80 kg
5. Written consent
6. Well functioning vascular access
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
10
Participant exclusion criteria
1. Known human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
2. Miscellaneous acute or chronic infections
3. Known coagulation disturbances
4. Known incompliance with respect to fluid restriction
Recruitment start date
01/01/2000
Recruitment end date
30/06/2000
Locations
Countries of recruitment
Germany
Trial participating centre
Holger-Crafoord-Str. 26
Hechingen
72379
Germany
Funders
Funder type
Industry
Funder name
Grant by Gambro Corporate Research (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
Basic results (scientific)
Publication list
No publication intended as of 23/10/2009