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

Renal Failure Clinical Trial

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?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01009229
• Other study ID #: Uehlinger-001
• Status: Completed
• Phase: N/A
• First received: November 5, 2009
• Last updated: May 24, 2011
• Start date: June 2009
• Est. completion date: July 2010

Study information

• Verified date: May 2011
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

• acceptance for living kidney donation

Exclusion Criteria:

• withdrawal of consent

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Living Donors
• Renal Failure
• Renal Transplantation

Intervention

Dietary Supplement:
• Low and high salt diets
High salt diet: 150mmol/d Low salt diet: 30mmol/d

Locations

Country	Name	City	State
Switzerland	Department of nephrology and hypertension, Universitiy of Bern	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Salt sensitivity, arterial hypertension		day 0, 14, 52, 156, 208, yearly	Yes