Diabetic NephropathiesNCT01918488
Increased Activity of a Renal Salt Transporter (ENaC) in Diabetic Kidney Disease
A study testing Standardized salt diet and Amiloride in people with Diabetic Nephropathies and Hypertension, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
The purpose of the study is to determine whether a diuretic drug called amiloride is capable of increasing renal salt excretion and thereby decrease blood pressure in diabetic patients with kidney disease. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Diabetic Nephropathies, Hypertension
- What is being tested?
- Standardized salt diet and Amiloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2013to Dec 2014
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 1 diabetes
- Negative pregnancy test at inclusion and taking contraceptive medication
- One group with diabetic nephropathy and overt proteinuria
- One normoalbuminuric group without nephropathy
- Creatinine clearance > 40 ml/min
Who cannot join
- Type 2 diabetes
- Receiving amiloride, glucocorticoids, aldosterone or spironolactone
- Clinically relevant organic or systemic disease including malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Increased Activity of the Epithelial Sodium Channel (ENaC) in Diabetic Nephropathy
The purpose of the study is to determine whether a diuretic drug called amiloride is capable of increasing renal salt excretion and thereby decrease blood pressure in diabetic patients with kidney disease. Our hypothesis states that amiloride is capable of reducing blood pressure in these patients and thus decrease the cardiovascular risk associated with diabetic kidney disease.
- Conditions
- Diabetic Nephropathies, Hypertension
- Being tested
- Standardized salt diet, Amiloride
- Keywords
- Diabetic Nephropathies, Hypertension, Proteinuria, Albuminuria, Epithelial Sodium Channels, Epithelial Sodium Channel Blockers, Amiloride
- Medical subject headings
- Diabetic Nephropathies, Hypertension, Proteinuria, Albuminuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized salt dietDietary supplement
200 mmol NaCl per day given as three meals daily for 4 consecutive days.
AmilorideDrug
Also called Triamterene
Amiloride tablet 20 mg two times daily (morning and afternoon) for two consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Nephropathy | Experimental | Diabetics with diabetic nephropathy receiving first a standardized salt diet (200 mmol NaCl/day) for 4 days and then amiloride tablet 20 mg two times daily (morning and afternoon) for 2 days. Receives: Dietary Supplement: Standardized salt diet; Drug: Amiloride |
| Control | Experimental | Diabetics without nephropathy receiving a standardized salt diet (200 mmol NaCl/day) for 4 days, then amiloride tablet 20 mg two times daily (morning and afternoon) for 2 days. Receives: Dietary Supplement: Standardized salt diet; Drug: Amiloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour urinary sodium excretion induced by amiloride
Measured: Change from baseline urinary sodium excretion at 24 hours after amiloride administration
Secondary outcomes (1)
Office blood pressure measurements
Measured: Change from baseline office blood pressure at day 4 of salt diet and at 24 hours after amiloride administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Diabetic NephropathiesStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital, Region of Southern Denmark, The Ministry of Science, Technology and Innovation, Denmark, Danish Heart Foundation
- Responsible party
- Principal investigator, Henrik Andersen, MD, University of Southern Denmark
- Investigators
- Henrik Andersen, MD, Principal investigator, University of Southern DenmarkJan Erik Henriksen, MD, PhD, Study director, Odense University HospitalClaus Bistrup, MD, PhD, Study director, Odense University HospitalBoye L Jensen, MD, PhD, Study director, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01918488
- Sponsor's protocol ID
- 2013-052
- Other IDs
- 13-04-R94-A4513-22770
- Status last verified
- Oct 2013
- First submitted
- 31 Jul 2013
- Last updated
- 16 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Svenningsen P, Bistrup C, Friis UG, Bertog M, Haerteis S, Krueger B, Stubbe J, Jensen ON, Thiesson HC, Uhrenholt TR, Jespersen B, Jensen BL, Korbmacher C, Skott O. Plasmin in nephrotic urine activates the epithelial sodium channel. J Am Soc Nephrol. 2009 Feb;20(2):299-310. doi: 10.1681/ASN.2008040364. Epub 2008 Dec 10.
PubMed 19073825Svenningsen P, Uhrenholt TR, Palarasah Y, Skjodt K, Jensen BL, Skott O. Prostasin-dependent activation of epithelial Na+ channels by low plasmin concentrations. Am J Physiol Regul Integr Comp Physiol. 2009 Dec;297(6):R1733-41. doi: 10.1152/ajpregu.00321.2009. Epub 2009 Sep 30.
PubMed 19793956Saha C, Eckert GJ, Ambrosius WT, Chun TY, Wagner MA, Zhao Q, Pratt JH. Improvement in blood pressure with inhibition of the epithelial sodium channel in blacks with hypertension. Hypertension. 2005 Sep;46(3):481-7. doi: 10.1161/01.HYP.0000179582.42830.1d. Epub 2005 Aug 22.
PubMed 16116042Buhl KB, Friis UG, Svenningsen P, Gulaveerasingam A, Ovesen P, Frederiksen-Moller B, Jespersen B, Bistrup C, Jensen BL. Urinary plasmin activates collecting duct ENaC current in preeclampsia. Hypertension. 2012 Nov;60(5):1346-51. doi: 10.1161/HYPERTENSIONAHA.112.198879. Epub 2012 Sep 17.
PubMed 22987920Isaksson GL, Hinrichs GR, Andersen H, Bach ML, Weyer K, Zachar R, Henriksen JE, Madsen K, Lund IK, Mollet G, Bistrup C, Birn H, Jensen BL, Palarasah Y. Amiloride Reduces Urokinase/Plasminogen-Driven Intratubular Complement Activation in Glomerular Proteinuria. J Am Soc Nephrol. 2024 Apr 1;35(4):410-425. doi: 10.1681/ASN.0000000000000312. Epub 2024 Jan 23.
PubMed 38254266
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increased Activity of the Epithelial Sodium Channel (ENaC) in Diabetic Nephropathy
- ClinicalTrials.gov ID
- NCT01918488
- Acronym / sponsor ID
- 2013-052
- Conditions
- Diabetic Nephropathies, Hypertension
- Keywords
- Diabetic Nephropathies, Hypertension, Proteinuria, Albuminuria, Epithelial Sodium Channels, Epithelial Sodium Channel Blockers, Amiloride
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Odense University Hospital, Region of Southern Denmark, The Ministry of Science, Technology and Innovation, Denmark, Danish Heart Foundation
- Study start
- Oct 2013
- Primary completion
- Dec 2014 (estimated)
- First posted
- 7 Aug 2013 (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.
The purpose of the study is to determine whether a diuretic drug called amiloride is capable of increasing renal salt excretion and thereby decrease blood pressure in diabetic patients with kidney disease. Our hypothesis states that amiloride is capable of reducing blood pressure in these patients and thus decrease the cardiovascular risk associated with diabetic kidney disease.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nephropathy | Experimental | Dietary Supplement: Standardized salt diet, Drug: AmilorideDiabetics with diabetic nephropathy receiving first a standardized salt diet (200 mmol NaCl/day) for 4 days and then amiloride tablet 20 mg two times daily (morning and afternoon) for 2 days. |
| Control | Experimental | Dietary Supplement: Standardized salt diet, Drug: AmilorideDiabetics without nephropathy receiving a standardized salt diet (200 mmol NaCl/day) for 4 days, then amiloride tablet 20 mg two times daily (morning and afternoon) for 2 days. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Type 1 diabetes
- Negative pregnancy test at inclusion and taking contraceptive medication
- One group with diabetic nephropathy and overt proteinuria
- One normoalbuminuric group without nephropathy
- Creatinine clearance > 40 ml/min
Key exclusion criteria (3 listed)
- Type 2 diabetes
- Receiving amiloride, glucocorticoids, aldosterone or spironolactone
- Clinically relevant organic or systemic disease including malignancy
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 |
|---|---|---|
| Standardized salt diet200 mmol NaCl per day given as three meals daily for 4 consecutive days. | Dietary supplement | Control, Nephropathy |
| AmilorideAlso: TriamtereneAmiloride tablet 20 mg two times daily (morning and afternoon) for two consecutive days. | Drug | Control, Nephropathy |
Primary outcome
24-hour urinary sodium excretion induced by amiloride
Time frame: Change from baseline urinary sodium excretion at 24 hours after amiloride administration
1 secondary outcome
Office blood pressure measurements
Time frame: Change from baseline office blood pressure at day 4 of salt diet and at 24 hours after amiloride administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2013.
- Background: PubMed 19073825Svenningsen P, Bistrup C, Friis UG, Bertog M, Haerteis S, Krueger B, Stubbe J, Jensen ON, Thiesson HC, Uhrenholt TR, Jespersen B, Jensen BL, Korbmacher C, Skott O. Plasmin in nephrotic urine activates the epithelial sodium channel. J Am Soc Nephrol. 2009 Feb;20(2):299-310. doi: 10.1681/ASN.2008040364. Epub 2008 Dec 10.
- Background: PubMed 19793956Svenningsen P, Uhrenholt TR, Palarasah Y, Skjodt K, Jensen BL, Skott O. Prostasin-dependent activation of epithelial Na+ channels by low plasmin concentrations. Am J Physiol Regul Integr Comp Physiol. 2009 Dec;297(6):R1733-41. doi: 10.1152/ajpregu.00321.2009. Epub 2009 Sep 30.
- Background: PubMed 16116042Saha C, Eckert GJ, Ambrosius WT, Chun TY, Wagner MA, Zhao Q, Pratt JH. Improvement in blood pressure with inhibition of the epithelial sodium channel in blacks with hypertension. Hypertension. 2005 Sep;46(3):481-7. doi: 10.1161/01.HYP.0000179582.42830.1d. Epub 2005 Aug 22.
- Background: PubMed 22987920Buhl KB, Friis UG, Svenningsen P, Gulaveerasingam A, Ovesen P, Frederiksen-Moller B, Jespersen B, Bistrup C, Jensen BL. Urinary plasmin activates collecting duct ENaC current in preeclampsia. Hypertension. 2012 Nov;60(5):1346-51. doi: 10.1161/HYPERTENSIONAHA.112.198879. Epub 2012 Sep 17.
- Derived from this study: PubMed 38254266Isaksson GL, Hinrichs GR, Andersen H, Bach ML, Weyer K, Zachar R, Henriksen JE, Madsen K, Lund IK, Mollet G, Bistrup C, Birn H, Jensen BL, Palarasah Y. Amiloride Reduces Urokinase/Plasminogen-Driven Intratubular Complement Activation in Glomerular Proteinuria. J Am Soc Nephrol. 2024 Apr 1;35(4):410-425. doi: 10.1681/ASN.0000000000000312. Epub 2024 Jan 23.
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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.
Henrik Andersen, MD principal investigator
University of Southern Denmark
Jan Erik Henriksen, MD, PhD study director
Odense University Hospital
Claus Bistrup, MD, PhD study director
Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized salt diet and Amiloride in people with Diabetic Nephropathies and Hypertension, run by University of Southern Denmark 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 5 inclusion and 3 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 16 Oct 2013. 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. 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?
Results are not available in the source record.
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?
24-hour urinary sodium excretion induced by amiloride (time frame: Change from baseline urinary sodium excretion at 24 hours after amiloride administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01918488, which also lists 5 linked publications.
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 16 Oct 2013.