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Trial registered on ANZCTR


Registration number
ACTRN12610000844044
Ethics application status
Approved
Date submitted
21/09/2010
Date registered
6/10/2010
Date last updated
6/10/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Arterial stiffness and renal outcome in kidney transplant patients
Scientific title
Arterial stiffness and renal outcome in kidney transplant patients
Secondary ID [1] 1049 0
CRG110600098 (Cochrane Renal Group)
Universal Trial Number (UTN)
Trial acronym
Arterial stiffness and renal outcome in kidney transplant patients
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Renal transplant patients 243764 0
vascular risk factors 258174 0
Condition category
Condition code
Renal and Urogenital 258356 258356 0 0
Kidney disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Cohort study to evaluate vascular risk markers in renal transplant recipients for patient and transplant survival for 5 years
methods: renal resistance index measured by color-coded duplex ultrasound; arterial sffness measured by pulse wave velocity; assymmetric dimethyl arginine measured by chromatography, angiopoetin2 measured by Enzyme-linked immunosorbent assay (ELISA)
Intervention code [1] 257195 0
Not applicable
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 240833 0
graft survival
(clinical Assessment and renal function tests)
Timepoint [1] 240833 0
3 and 5 years from baseline
Secondary outcome [1] 257503 0
Patient survival
( clinical assessment)
Timepoint [1] 257503 0
3 and 5 years from baseline
Secondary outcome [2] 265590 0
return to dialysis

(clinical assessement and renal function tests)
Timepoint [2] 265590 0
3 and 5 years from baseline

Eligibility
Key inclusion criteria
- at least 6 months after kidney transplantation

- stable transplant function

- >= 18 years old

- written informed consent
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- cardiac arrhythmies which make a measurement of arterial stiffness and renal resistance index impossible

- transplant artery stenosis of > 50% of diameter

- postrenal obstruction (grade 2 or more)

- significant compression of the tr

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 2084 0
Switzerland
State/province [1] 2084 0

Funding & Sponsors
Funding source category [1] 257651 0
Hospital
Name [1] 257651 0
University Hospital Bern
Address [1] 257651 0
Freiburgstrasse
3010 Bern
Switzerland
Country [1] 257651 0
Switzerland
Primary sponsor type
Individual
Name
PD Dr. Ute Eisenberger
Address
University Hospital Bern
Dep. of Nephrology and Hypertension
Freiburgstr. 10
3010 Bern
Switzerland
Country
Switzerland
Secondary sponsor category [1] 256904 0
None
Name [1] 256904 0
Address [1] 256904 0
Country [1] 256904 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Bergmann I, Boeger RH, Marti E, Schwedthelm, Frey FJ, Eisenberger U. Renal Resistance Index in Renal Allograft Recipients: A Role for Asymmetric Dimethylarginine.
Am J Kidney Dis. 2009, 54(2): 327-33
Public notes

Contacts
Principal investigator
Name 30218 0
Address 30218 0
Country 30218 0
Phone 30218 0
Fax 30218 0
Email 30218 0
Contact person for public queries
Name 13465 0
PD Dr, Ute, Eisenberger
Address 13465 0
senior registrar, Nephrology and Hypertension, University Hospital Inselspital, Freiburgstrasse 10, CH-3010 Bern, Switzerland
Country 13465 0
Switzerland
Phone 13465 0
+41 31 6323144
Fax 13465 0
Email 13465 0
ute.eisenberger@insel.ch
Contact person for scientific queries
Name 4393 0
PD Dr, Ute, Eisenberger
Address 4393 0
registrar, Nephrology and Hypertension, University Hospital Inselspital, Freiburgstrasse 10, CH-3010 Bern, Switzerland
Country 4393 0
Switzerland
Phone 4393 0
+41 31 6323144
Fax 4393 0
Email 4393 0
ute.eisenberger@insel.ch

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary