Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Sex
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
1/10/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
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
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
[email protected]
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
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.