NCT01009229

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 6, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

May 25, 2011

Status Verified

May 1, 2011

Enrollment Period

1.1 years

First QC Date

November 5, 2009

Last Update Submit

May 24, 2011

Conditions

Outcome Measures

Primary Outcomes (1)

  • Salt sensitivity, arterial hypertension

    day 0, 14, 52, 156, 208, yearly

Study Arms (1)

1

OTHER
Dietary Supplement: Low and high salt diets

Interventions

Low and high salt dietsDIETARY_SUPPLEMENT

High salt diet: 150mmol/d Low salt diet: 30mmol/d

Also known as: NaCl
1

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • acceptance for living kidney donation

You may not qualify if:

  • withdrawal of consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of nephrology and hypertension, Universitiy of Bern

Bern, Canton of Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Felix J Frey, Prof

    University of Berne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 5, 2009

First Posted

November 6, 2009

Study Start

June 1, 2009

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

May 25, 2011

Record last verified: 2011-05

Locations