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A Reduced 11-b-HSD Activity, a Novel Mechanism of Salt Sensitivity and Hypertension After Renal Allograft Donation?

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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01009229
Recruitment Status : Completed
First Posted : November 6, 2009
Last Update Posted : May 25, 2011
Sponsor:
Information provided by:
University Hospital Inselspital, Berne

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.

Condition or disease Intervention/treatment Phase
Renal Failure Renal Transplantation Living Donors Dietary Supplement: Low and high salt diets Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2009
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Sodium

Arm Intervention/treatment
1 Dietary Supplement: Low and high salt diets
High salt diet: 150mmol/d Low salt diet: 30mmol/d
Other Name: NaCl




Primary Outcome Measures :
  1. Salt sensitivity, arterial hypertension [ Time Frame: day 0, 14, 52, 156, 208, yearly ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • acceptance for living kidney donation

Exclusion Criteria:

  • withdrawal of consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01009229


Locations
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Switzerland
Department of nephrology and hypertension, Universitiy of Bern
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
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Principal Investigator: Felix J Frey, Prof University of Berne
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Responsible Party: Felix Frey, Department of Nephrology and Hypertension, University of Berne, Switzerland
ClinicalTrials.gov Identifier: NCT01009229    
Other Study ID Numbers: Uehlinger-001
First Posted: November 6, 2009    Key Record Dates
Last Update Posted: May 25, 2011
Last Verified: May 2011
Additional relevant MeSH terms:
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Renal Insufficiency
Hypertension
Vascular Diseases
Cardiovascular Diseases
Kidney Diseases
Urologic Diseases