The Effect of Acyl-Ghrelin on Kidney Function and Blood P... | NCT02528422

Studies
The Effect of Acyl-Ghrelin on Kidney Function and Blood Pressure in Healthy Volunteers

NCT02528422

Sponsor

Erling Bjerregaard Pedersen

Status

Unknown status

Last Update Posted

Aug 19, 2015Estimated

Enrollment

15Estimated

Phase

Phase 1

Conditions

Renal Tubular Transport

Interventions

Acyl-Ghrelin

Countries

Denmark

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

ID	Type	Description	Link
2014-004496-23	EudraCT Number

Official Title

The Effect of Acyl-Ghrelin on Kidney Function and Blood Pressure in Healthy Volunteers - A Randomized, Cross-over, Single-blind, Placebo-controlled Dose-response Study of the Acyl-ghrelin Induced Effects on GFR, Tubular Transport of Sodium and Water in Different Nephron Segments and Central and Peripheral Blood Pressure

Status Module

Record Verification Date

Aug 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2015

Primary Completion Date

Jan 2018Estimated

Completion Date

Jan 2018Estimated

First Submitted Date

Aug 17, 2015

First Submission Date that Met QC Criteria

Aug 18, 2015

First Posted Date

Aug 19, 2015Estimated

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

Aug 18, 2015

Last Update Posted Date

Aug 19, 2015Estimated

Name	Class
University of Aarhus	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Ghrelin (growth hormone release inducer) is produced in the stomach. The active form of Ghrelin is Acyl-Ghrelin. Acyl-Ghrelin stimulates the Ghrelin receptors. Ghrelin receptors are detected in the distal tubules in mice and animal studies have shown that Ghrelin increases the absorption of sodium in the renal tubules. Ghrelin infusion directly into the renal artery of rats increased sodium reabsorption in the distal nephron, presumably via the epithelial sodium channels (ENaC).

The purpose of the study is to measure the acyl-ghrelin induced effects on GFR, tubular transport of sodium and water in different nephron segments and central and peripheral blood pressure in a randomized, cross-over, single-blind, placebo-controlled dose-response study.

Detailed Description

Not provided

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

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
50 µg Acyl-Ghrelin	Active Comparator	Intravenous injection on examination day.	Drug: Acyl-Ghrelin
100 µg Acyl-Ghrelin	Active Comparator	Intravenous injection on examination day.	Drug: Acyl-Ghrelin
Isotonic Sodium Chloride	Placebo Comparator	Intravenous injection on examination day.	Drug: Acyl-Ghrelin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Acyl-Ghrelin	Drug		100 µg Acyl-Ghrelin 50 µg Acyl-Ghrelin Isotonic Sodium Chloride

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fractional sodium excreation (FENa)	Measurement of FENa at baseline and after Acyl-Ghrelin injection	5-6 Hours

Secondary Outcomes

Measure	Description	Time Frame
Renal function	Measurement of GFR, FEK and CH20 at baseline and after Acyl-Ghrelin injection	5-6 Hours
Water and sodium transport	Measurement of u-AQP2, u-NCC , u-NKCC -2 and u-ENaC at baseline and after Acyl-Ghrelin

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18-40 years,
BMI 18,5-30kg/m2,
women must use contraception.

Exclusion Criteria:

Tobacco smoking,
substance abuse,
consumption of more than 7 units of alcohol/week for women and more than 14 units/week for men,
medical treatment except for contraception,
pregnancy or nursing,
allergy to acyl-ghrelin,
significant clinical signs of heart-, lung-, liver-, kidney-, endocrine-, brain- or neoplastic disorders,
clinically significant abnormal findings in screening blood samples,
urine sample or ECG,
office blood pressure over 140/90 mmHg,
donation of blood within 1 month of the first day of investigation.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
My ES Malmberg	Contact	+4578436588		mymalmbe@rm.dk

Overall Officials

Name	Affiliation	Role
Erling B Pedersen	Department of Medical Research and Medicine, Holstebro Regional Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Medical Research, Regional Hospital Holstebro	Recruiting	Holstebro		7500	Denmark

Intervention Browse Module

MeSH Terms

ID	Term
C000710987	acyl-ghrelin

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided