A Reduced 11-b-HSD Activity, a Novel Mechanism of Salt Se... | NCT01009229

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

NCT01009229

Sponsor

Insel Gruppe AG, University Hospital Bern

Status

Completed

Last Update Posted

May 25, 2011Estimated

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Renal Failure
Renal Transplantation
Living Donors

Interventions

Low and high salt diets

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2009

Primary Completion Date

Jul 2010Actual

Completion Date

Jul 2010Actual

First Submitted Date

Nov 5, 2009

First Submission Date that Met QC Criteria

Nov 5, 2009

First Posted Date

Nov 6, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 24, 2011

Last Update Posted Date

May 25, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Other		Dietary Supplement: Low and high salt diets

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Low and high salt diets	Dietary Supplement	High salt diet: 150mmol/d Low salt diet: 30mmol/d	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Salt sensitivity, arterial hypertension		day 0, 14, 52, 156, 208, yearly

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

acceptance for living kidney donation

Exclusion Criteria:

withdrawal of consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Felix J Frey, Prof	University of Berne	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of nephrology and hypertension, Universitiy of Bern		Bern	Canton of Bern	3010	Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D051437	Renal Insufficiency

Ancestor Terms

ID	Term
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided