Renal Tubular TransportPhase 1DOAGNCT02528422
The Effect of Acyl-Ghrelin on Kidney Function and Blood Pressure in Healthy Volunteers
A Phase 1 study testing Acyl-Ghrelin in people with Renal Tubular Transport, run by Erling Bjerregaard Pedersen at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Tubular Transport
- What is being tested?
- Acyl-Ghrelin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteDenmark
- Study dates
- May 2015to Jan 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-40 years,
- BMI 18,5-30kg/m2,
- women must use contraception.
Who cannot join
- 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,
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- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Department of Medical Research, Regional Hospital Holstebro
Holstebro, 7500
About this study
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
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.
- Conditions
- Renal Tubular Transport
- Being tested
- Acyl-Ghrelin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acyl-GhrelinDrug
| Study group | Role | What they receive |
|---|---|---|
| 50 µg Acyl-Ghrelin | Active comparator | Intravenous injection on examination day. Receives: Drug: Acyl-Ghrelin |
| 100 µg Acyl-Ghrelin | Active comparator | Intravenous injection on examination day. Receives: Drug: Acyl-Ghrelin |
| Isotonic Sodium Chloride | Placebo comparator | Intravenous injection on examination day. Receives: Drug: Acyl-Ghrelin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fractional sodium excreation (FENa)
Measurement of FENa at baseline and after Acyl-Ghrelin injection
Measured: 5-6 Hours
Secondary outcomes (4)
Renal function
Measurement of GFR, FEK and CH20 at baseline and after Acyl-Ghrelin injection
Measured: 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
Measured: 5-6 Hours
Vasoactive hormones
Measurement of p-BNP , PRC, p-AngII , p-Aldo and p-AVP at baseline and after Acyl-Ghrelin
Measured: 5-6 Hours
Blood pressure
Measurement of Central blood pressure, PWV, AIx and Peripheral blood pressure at baseline and after Acyl-Ghrelin
Measured: 5-6 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2015 (estimated)
- Study startMay 2015
- Primary completionJan 2018 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Tubular TransportStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erling Bjerregaard Pedersen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus
- Responsible party
- Sponsor-investigator, Erling Bjerregaard Pedersen, Regional Hospital Holstebro
- Investigators
- Erling B Pedersen, Study chair, Department of Medical Research and Medicine, Holstebro Regional Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02528422
- Sponsor's protocol ID
- MY-1-2014
- Other IDs
- 2014-004496-23, 2014
- Acronym
- DOAG
- Status last verified
- Aug 2015
- First submitted
- 17 Aug 2015
- Last updated
- 19 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02528422
- Acronym / sponsor ID
- DOAG / MY-1-2014
- Conditions
- Renal Tubular Transport
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Erling Bjerregaard PedersenUniversity, hospital or other
- Collaborators
- University of Aarhus
- Study start
- May 2015
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 19 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 50 µg Acyl-Ghrelin | Active comparator | Drug: Acyl-GhrelinIntravenous injection on examination day. |
| 100 µg Acyl-Ghrelin | Active comparator | Drug: Acyl-GhrelinIntravenous injection on examination day. |
| Isotonic Sodium Chloride | Placebo comparator | Drug: Acyl-GhrelinIntravenous injection on examination day. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18-40 years,
- BMI 18,5-30kg/m2,
- women must use contraception.
Key exclusion criteria (11 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acyl-Ghrelin | Drug | 100 µg Acyl-Ghrelin, 50 µg Acyl-Ghrelin, Isotonic Sodium Chloride |
Primary outcome
Fractional sodium excreation (FENa)
Time frame: 5-6 Hours
Measurement of FENa at baseline and after Acyl-Ghrelin injection
4 secondary outcomes
Renal function
Time frame: 5-6 Hours
Water and sodium transport
Time frame: 5-6 Hours
Vasoactive hormones
Time frame: 5-6 Hours
Blood pressure
Time frame: 5-6 Hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erling B Pedersen study chair
Department of Medical Research and Medicine, Holstebro Regional Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Acyl-Ghrelin in people with Renal Tubular Transport, run by Erling Bjerregaard Pedersen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact My ES Malmberg (+4578436588, mymalmbe@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fractional sodium excreation (FENa) (time frame: 5-6 Hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2015.