NephropathyTHAMNCT01635231
The Effect of Thiazide, Amiloride and Hypertonic Saline on Urinary Biomarkers in Healthy Subjects
A study testing hypertonic saline in people with Nephropathy, run by Regional Hospital Holstebro at 1 site in Denmark.
Trial summary
Urinary biomarkers (u-NKCC2, u-ENaC-gamma and u-AQP2) reflects the activity of the sodium- and water channels in the human kidney. Changes in the sodium-and water channel activity can be induced by blocking the sodium channels with diuretics in healthy subjects Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Nephropathy
- What is being tested?
- hypertonic saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteDenmark
- Study dates
- Jul 2012to Nov 2013
- 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy males and females
- age 18-45
- BMI range 18,5-30,0 kg/m2
Who cannot join
- hypertension (i.e. ambulatory BP > 130 mmHg systolic or/and > 80 mmHg diastolic)
- history or clinical significant signs of heart, lung, liver, kidney, endocrine, brain or neoplastic
- disease.
- alcohol abuse
- drug abuse
- smoking
Show all 9Show fewer
- pregnancy or nursing
- blood donation within a month prior to examination
- medical treatment apart from oral contraception abnormal blood samples, -ECG and -urine dipstick, drug abuse, alcohol abuse, pregnancy, medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Thiazide, Amiloride and Hypertonic Saline on Sodium- and Water Channel Activity in the Nephron in Healthy Subjects Estimated by Urinary Biomarkers
Urinary biomarkers (u-NKCC2, u-ENaC-gamma and u-AQP2) reflects the activity of the sodium- and water channels in the human kidney.
Changes in the sodium-and water channel activity can be induced by blocking the sodium channels with diuretics in healthy subjects
Read the detailed description
- Urinary biomarkers (u-NKCC2, u-ENaC-gamma and u-AQP2) reflects the kidneys transport of sodium and water in the nephron.
- Changes in the sodium-and water channel activity is induced by blocking the NCC channels with thiazide and ENaC channels with amiloride and by intervention with hypertonic NaCl The changes in sodium-and water channels are followed by changes in extracellular and intracellular fluids, central bloodpressure and the plasma concentration of vasoactive hormones.
The purpose of this study is to investigate the changes in urinary biomarkers (u-NKCC2, u-ENaC-gamma and u-AQP2), extra- and intracellular fluid compartments, central bloodpressure and the plasma concentration of Vasoactive hormones in healthy subjects under a) treatment with Amiloride and Thiazide at baseline and b) after and acute infusion with hypertonic saline.
Subjects will be examined on three examination days. Four days prior to the examination days the subjects will consume a standard diet based on amount of sodium and calories and randomized to treatment with either thiazide, amiloride or placebo twice daily for 5 days. On the examination days the subjects receive an infusion with hypertonic saline.
Renal function is measured by renal clearance of 51Cr-EDTA. Urinary biomarkers (u-NKCC2, u-ENaC-gamma and u-AQP2) will be measured to evaluate the activity of water- and sodium channels in the nephron, changes in fluid compartments are measured by body composition monitor. Central blood pressure is measured by sphygmocor.
- Conditions
- Nephropathy
- Being tested
- hypertonic saline
- Keywords
- Nephrology, sodium-channels, water-channels, BCM, central blood pressure
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypertonic salineOther
Also called NaCl 3.0 %
hypertonic saline 3.0% 7 ml/kg
| Study group | Role | What they receive |
|---|---|---|
| thiazide, diuretic | Active comparator | 1.25 mg thiazide twice daily for 5 days Receives: Other: hypertonic saline |
| amiloride, diuretic | Active comparator | 5 mg of amiloride twice daily Receives: Other: hypertonic saline |
| calcium | Placebo comparator | placebo twice daily for 5 days Receives: Other: hypertonic saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
urinary biomarkers
Urinary excretion of epithelial sodium channels (ENaC), Sodium-potassium-2chloride transporters (NKCC2) and aquaporin2 channels (AQP2) before, during and after fluid infusion
Measured: baseline, 0 hours and 1.5 hours after intervention
Secondary outcomes (3)
vaso active hormones
plasma concentrations of: renin, Angiotensin II, aldosterone, Vasopressin, ANP and BNP
Measured: baseline, 0 hours and 1.5 hours after intervention
central blood pressure
measured by applanation-tonometry
Measured: baseline, 0 hours and 1.5 hours after intervention
intracellular (ICV)- and extracellular volume (ECV)
change in ICV and EVC from baseline and after intervention measured in liters by body composition monitor (BCM)
Measured: baseline, 0 hours and 1.5 hours after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionSep 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NephropathyStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regional Hospital Holstebro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erling Bjerregaard Pedersen, Regional Hospital Holstebro
- Investigators
- Erling B Pedersen, MD, DMSc, Study director, Medical Research, Holstebro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01635231
- Sponsor's protocol ID
- EBP-JMJ-2012-1
- Acronym
- THAM
- Status last verified
- Mar 2014
- First submitted
- 13 Jun 2012
- Last updated
- 4 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Thiazide, Amiloride and Hypertonic Saline on Sodium- and Water Channel Activity in the Nephron in Healthy Subjects Estimated by Urinary Biomarkers
- ClinicalTrials.gov ID
- NCT01635231
- Acronym / sponsor ID
- THAM / EBP-JMJ-2012-1
- Conditions
- Nephropathy
- Keywords
- Nephrology, sodium-channels, water-channels, BCM, central blood pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Regional Hospital HolstebroUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 9 Jul 2012 (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.
Urinary biomarkers (u-NKCC2, u-ENaC-gamma and u-AQP2) reflects the activity of the sodium- and water channels in the human kidney.
Changes in the sodium-and water channel activity can be induced by blocking the sodium channels with diuretics in healthy subjects
Detailed description
- Urinary biomarkers (u-NKCC2, u-ENaC-gamma and u-AQP2) reflects the kidneys transport of sodium and water in the nephron.
- Changes in the sodium-and water channel activity is induced by blocking the NCC channels with thiazide and ENaC channels with amiloride and by intervention with hypertonic NaCl The changes in sodium-and water channels are followed by changes in extracellular and intracellular fluids, central bloodpressure and the plasma concentration of vasoactive hormones.
The purpose of this study is to investigate the changes in urinary biomarkers (u-NKCC2, u-ENaC-gamma and u-AQP2), extra- and intracellular fluid compartments, central bloodpressure and the plasma concentration of Vasoactive hormones in healthy subjects under a) treatment with Amiloride and Thiazide at baseline and b) after and acute infusion with hypertonic saline.
Subjects will be examined on three examination days. Four days prior to the examination days the subjects will consume a standard diet based on amount of sodium and calories and randomized to treatment with either thiazide, amiloride or placebo twice daily for 5 days. On the examination days the subjects receive an infusion with hypertonic saline.
Renal function is measured by renal clearance of 51Cr-EDTA. Urinary biomarkers (u-NKCC2, u-ENaC-gamma and u-AQP2) will be measured to evaluate the activity of water- and sodium channels in the nephron, changes in fluid compartments are measured by body composition monitor. Central blood pressure is measured by sphygmocor.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| thiazide, diuretic | Active comparator | Other: hypertonic saline1.25 mg thiazide twice daily for 5 days |
| amiloride, diuretic | Active comparator | Other: hypertonic saline5 mg of amiloride twice daily |
| calcium | Placebo comparator | Other: hypertonic salineplacebo twice daily for 5 days |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- healthy males and females
- age 18-45
- BMI range 18,5-30,0 kg/m2
Key exclusion criteria (9 listed)
- hypertension (i.e. ambulatory BP > 130 mmHg systolic or/and > 80 mmHg diastolic)
- history or clinical significant signs of heart, lung, liver, kidney, endocrine, brain or neoplastic
- disease.
- alcohol abuse
- drug abuse
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 |
|---|---|---|
| hypertonic salineAlso: NaCl 3.0 %hypertonic saline 3.0% 7 ml/kg | Other | amiloride, diuretic, calcium, thiazide, diuretic |
Primary outcome
urinary biomarkers
Time frame: baseline, 0 hours and 1.5 hours after intervention
Urinary excretion of epithelial sodium channels (ENaC), Sodium-potassium-2chloride transporters (NKCC2) and aquaporin2 channels (AQP2) before, during and after fluid infusion
3 secondary outcomes
vaso active hormones
Time frame: baseline, 0 hours and 1.5 hours after intervention
central blood pressure
Time frame: baseline, 0 hours and 1.5 hours after intervention
intracellular (ICV)- and extracellular volume (ECV)
Time frame: baseline, 0 hours and 1.5 hours after intervention
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 4 Mar 2014.
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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, MD, DMSc study director
Medical Research, Holstebro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hypertonic saline in people with Nephropathy, run by Regional Hospital Holstebro 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 9 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 4 Mar 2014. 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.
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?
urinary biomarkers (time frame: baseline, 0 hours and 1.5 hours after intervention). 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 4 Mar 2014.