Back to resultsA Reduced 11-b-HSD Activity, a Novel Mechanism of Salt Sensitivity and Hypertension After Renal Allograft Donation?
Primary Purpose
Renal Failure, Renal Transplantation, Living Donors
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Low and high salt diets
Sponsored by
About this trial
This is an interventional treatment trial for Renal Failure
Eligibility Criteria
Inclusion Criteria:
- acceptance for living kidney donation
Exclusion Criteria:
- withdrawal of consent
Sites / Locations
- Department of nephrology and hypertension, Universitiy of Bern
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Salt sensitivity, arterial hypertension
Secondary Outcome Measures
Full Information
NCT ID
NCT01009229
First Posted
November 5, 2009
Last Updated
May 24, 2011
Sponsor
Insel Gruppe AG, University Hospital Bern
1. Study Identification
Unique Protocol Identification Number
NCT01009229
Brief Title
A Reduced 11-b-HSD Activity, a Novel Mechanism of Salt Sensitivity and Hypertension After Renal Allograft Donation?
Official Title
A Reduced 11 Beta Hydroxysteroid Dehydrogenase 2 (11 Beta HSD2) Activity, a Novel Mechanism of Salt Sensitivity and Hypertension After Renal Allograft Donation?
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Consecutive living-kidney donor candidates (n=100) will be recruited after being accepted for donation according to official guidelines. An assessment of salt sensitivity, 11 beta HSD activity, 24 hour blood pressure, urine collection and physical exam will be performed prior nephrectomy and 14, 52, 156, 208 days post-nephrectomy.
Detailed Description
Consecutive living-kidney donor candidates (n=100) will be recruited after being accepted for donation. The assessment of salt sensitivity, 11 beta HSD activity, 24 hour blood pressure, urine collection and physical exam will be performed prior nephrectomy and 14, 52, 156, 208 days post-nephrectomy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Failure, Renal Transplantation, Living Donors
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Intervention Type
Dietary Supplement
Intervention Name(s)
Low and high salt diets
Other Intervention Name(s)
NaCl
Intervention Description
High salt diet: 150mmol/d Low salt diet: 30mmol/d
Primary Outcome Measure Information:
Title
Salt sensitivity, arterial hypertension
Time Frame
day 0, 14, 52, 156, 208, yearly
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
acceptance for living kidney donation
Exclusion Criteria:
withdrawal of consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Felix J Frey, Prof
Organizational Affiliation
University of Berne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of nephrology and hypertension, Universitiy of Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
A Reduced 11-b-HSD Activity, a Novel Mechanism of Salt Sensitivity and Hypertension After Renal Allograft Donation?
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