Arginine Vasopressin DeficiencyURANOSNCT05890690
Plasma Copeptin in Response to Oral Urea in Healthy Adults and Patients With Polyuria-polydipsia Syndrome
A study testing Urea in people with Arginine Vasopressin Deficiency and Primary Polydipsia, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The aim of this study is to investigate whether oral urea stimulates copeptin release and, if so, whether it may provide a novel diagnostic test in the differentiation between AVP-D (Arginine vasopressin deficiency) and PP (primary polydipsia). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Arginine Vasopressin Deficiency, Primary Polydipsia
- What is being tested?
- Urea
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteSwitzerland
- Study dates
- 2 Jun 2023to 24 Jun 2024
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Healthy with no medication except hormonal contraception
- Age ≥ 18 years
- Documented PP or AVP-D based on accepted diagnostic criteria, i.e., water deprivation test, hypertonic saline infusion test or arginine infusion test. Accordingly, patients must have evidence of disordered drinking habits and diuresis defined as polyuria >50ml/kg body weight/24h and polydipsia >3l /24h or must be on regular daily desmopressin medication
Who cannot join
- Participation in a trial with investigational drugs within 30 days
- Evidence of disordered drinking habits and diuresis defined as polyuria >50ml/kg body weight/24h and polydipsia >3l /24h
- Known allergy towards components of the study drink
- Pregnancy and breastfeeding
- Intention to become pregnant during the study
- Evidence of acute illness
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- Patients
- Participation in a trial with investigational drugs within 30 days
- Known allergy towards components of the study drink
- Pregnancy and breastfeeding
- Evidence of acute illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Plasma Copeptin in Response to Oral Urea in Healthy Adults and Patients With Polyuria-polydipsia Syndrome: a Double-blind, Randomized, Placebo-controlled Cross-over Proof-of-concept and Pilot Study - The URANOS Study
The aim of this study is to investigate whether oral urea stimulates copeptin release and, if so, whether it may provide a novel diagnostic test in the differentiation between AVP-D (Arginine vasopressin deficiency) and PP (primary polydipsia).
Read the detailed description
This study consists of two parts, including healthy adults (study part 1 - proof of concept) and adults with an established diagnosis of PP or AVP-D (study part 2 - pilot study).
If the results of study part 1 suggest that oral urea is a potent stimulator of copeptin in healthy adults, study part 2 will be conducted, meaning that adults with an established diagnosis of PP or AVP-D will be included. If study part 1 demonstrates no relevant copeptin increase in response to oral urea, the study will be terminated thereafter and study part 2 will not be conducted.
- Being tested
- Urea, Placebo
- Keywords
- diabetes insipidus, copeptin, oral urea
- Medical subject headings
- Diabetes Insipidus, Neurogenic, Polydipsia, Psychogenic, Diabetes Insipidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UreaDiagnostic test
Diagnostic test with a single weight-adapted dose of oral urea dissolved in 200 ml water together with 5 g of lemon-lime flavor powder (containing maltodextrin and citric acid).
The investigators will make use of the lemon-lime flavor to soften the bitter taste of urea.
- Dose calculation: 0.5 g urea/kg body weight (rounded to no decimal places), with a minimal dose of 30g and a maximal dose of 45g.
PlaceboDiagnostic test
Diagnostic test with a single weight-adapted dose of placebo dissolved in 200 ml water together with 5 g of lemon-lime flavor powder (containing maltodextrin and citric acid).
The placebo will contain a mixture of bitter herbal substances to mimic the taste of urea.
- Dose calculation: 22 ml of placebo containing 20 ml Ergytonyl®, 1 ml Carmol®, and 1 ml Bitter Liebe®.
| Study group | Role | What they receive |
|---|---|---|
| Study Part 1 urea followed by placebo | Experimental | Participants will undergo a diagnostic test with a single weight-adapted dose of oral urea first. After a a wash-out phase of at least 3 days and not more than 28 days participants will undergo a second diagnostic test with a single weight-adapted dose of placebo. Receives: Diagnostic Test: Urea; Diagnostic Test: Placebo |
| Study Part 1 placebo followed by urea | Experimental | Participants will undergo a diagnostic test with a single weight-adapted dose of placebo first. After a a wash-out phase of at least 3 days and not more than 28 days participants will undergo a second diagnostic test with a single weight-adapted dose of urea. Receives: Diagnostic Test: Urea; Diagnostic Test: Placebo |
| Study part 2 Urea | Experimental | Participants will undergo a diagnostic test with a single weight-adapted dose of oral urea Receives: Diagnostic Test: Urea |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in maximal increase in copeptin levels in plasma (pmol/l)
The difference in maximal increase in copeptin levels in plasma (pmol/l) within 150 minutes after oral intake of urea versus placebo, with the maximal increase being the difference between baseline copeptin values measured at the beginning of the test and maximal values measured between 30 and 150 minutes after ingestion.
Measured: up to 6 time assessment until 150 minutes after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2023
- Study start2 Jun 2023
- Primary completion24 Jun 2024
- Study completion24 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arginine Vasopressin DeficiencyStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- double-blind, randomized, placebo-controlled cross-over proof-of-concept and pilot study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mirjam Christ-Crain, Prof., Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05890690
- Sponsor's protocol ID
- 2023-00751; kt23christcrain2
- Other IDs
- 2023
- Acronym
- URANOS
- Status last verified
- Jul 2024
- First submitted
- 23 May 2023
- Last updated
- 9 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Copeptin in Response to Oral Urea in Healthy Adults and Patients With Polyuria-polydipsia Syndrome: a Double-blind, Randomized, Placebo-controlled Cross-over Proof-of-concept and Pilot Study - The URANOS Study
- ClinicalTrials.gov ID
- NCT05890690
- Acronym / sponsor ID
- URANOS / 2023-00751; kt23christcrain2
- Keywords
- diabetes insipidus, copeptin, oral urea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 2 Jun 2023 (actual)
- Primary completion
- 24 Jun 2024 (actual)
- Study completion
- 24 Jun 2024 (actual)
- First posted
- 6 Jun 2023 (actual)
- 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.
The aim of this study is to investigate whether oral urea stimulates copeptin release and, if so, whether it may provide a novel diagnostic test in the differentiation between AVP-D (Arginine vasopressin deficiency) and PP (primary polydipsia).
Detailed description
This study consists of two parts, including healthy adults (study part 1 - proof of concept) and adults with an established diagnosis of PP or AVP-D (study part 2 - pilot study).
If the results of study part 1 suggest that oral urea is a potent stimulator of copeptin in healthy adults, study part 2 will be conducted, meaning that adults with an established diagnosis of PP or AVP-D will be included. If study part 1 demonstrates no relevant copeptin increase in response to oral urea, the study will be terminated thereafter and study part 2 will not be conducted.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- double-blind, randomized, placebo-controlled cross-over proof-of-concept and pilot study
| Arm | Type | Receives |
|---|---|---|
| Study Part 1 urea followed by placebo | Experimental | Diagnostic Test: Urea, Diagnostic Test: PlaceboParticipants will undergo a diagnostic test with a single weight-adapted dose of oral urea first. After a a wash-out phase of at least 3 days and not more than 28 days participants will undergo a second diagnostic test with a single weight-adapted dose of placebo. |
| Study Part 1 placebo followed by urea | Experimental | Diagnostic Test: Urea, Diagnostic Test: PlaceboParticipants will undergo a diagnostic test with a single weight-adapted dose of placebo first. After a a wash-out phase of at least 3 days and not more than 28 days participants will undergo a second diagnostic test with a single weight-adapted dose of urea. |
| Study part 2 Urea | Experimental | Diagnostic Test: UreaParticipants will undergo a diagnostic test with a single weight-adapted dose of oral urea |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years
- Healthy with no medication except hormonal contraception
- Age ≥ 18 years
- Documented PP or AVP-D based on accepted diagnostic criteria, i.e., water deprivation test, hypertonic saline infusion test or arginine infusion test. Accordingly, patients must have evidence of disordered drinking habits and diuresis defined as polyuria >50ml/kg body weight/24h and polydipsia >3l /24h or must be on regular daily desmopressin medication
Key exclusion criteria (11 listed)
- Participation in a trial with investigational drugs within 30 days
- Evidence of disordered drinking habits and diuresis defined as polyuria >50ml/kg body weight/24h and polydipsia >3l /24h
- Known allergy towards components of the study drink
- Pregnancy and breastfeeding
- Intention to become pregnant during the study
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 |
|---|---|---|
| UreaDiagnostic test with a single weight-adapted dose of oral urea dissolved in 200 ml water together with 5 g of lemon-lime flavor powder (containing maltodextrin and citric acid). The investigators will make use of the lemon-lime flavor to soften the bitter taste of urea. - Dose calculation: 0.5 g urea/kg body weight (rounded to no decimal places), with a minimal dose of 30g and a maximal dose of 45g. | Diagnostic test | Study Part 1 placebo followed by urea, Study Part 1 urea followed by placebo, Study part 2 Urea |
| PlaceboDiagnostic test with a single weight-adapted dose of placebo dissolved in 200 ml water together with 5 g of lemon-lime flavor powder (containing maltodextrin and citric acid). The placebo will contain a mixture of bitter herbal substances to mimic the taste of urea. - Dose calculation: 22 ml of placebo containing 20 ml Ergytonyl®, 1 ml Carmol®, and 1 ml Bitter Liebe®. | Diagnostic test | Study Part 1 placebo followed by urea, Study Part 1 urea followed by placebo |
Primary outcome
Difference in maximal increase in copeptin levels in plasma (pmol/l)
Time frame: up to 6 time assessment until 150 minutes after baseline
The difference in maximal increase in copeptin levels in plasma (pmol/l) within 150 minutes after oral intake of urea versus placebo, with the maximal increase being the difference between baseline copeptin values measured at the beginning of the test and maximal values measured between 30 and 150 minutes after ingestion.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
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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.
Mirjam Christ-Crain, Prof. principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urea in people with Arginine Vasopressin Deficiency and Primary Polydipsia, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 4 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: finished, as of the sponsor's last update on 9 Jul 2024. 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 Switzerland. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in maximal increase in copeptin levels in plasma (pmol/l) (time frame: up to 6 time assessment until 150 minutes after baseline). 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 9 Jul 2024.