Increased Activity of a Renal Salt Transporter (ENaC) in Diabetic Kidney Disease
NCT ID: NCT01918488
Last Updated: 2013-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
80 participants
INTERVENTIONAL
2013-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Nephropathy
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.
Standardized salt diet
200 mmol NaCl per day given as three meals daily for 4 consecutive days.
Amiloride
Amiloride tablet 20 mg two times daily (morning and afternoon) for two consecutive days.
Control
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.
Standardized salt diet
200 mmol NaCl per day given as three meals daily for 4 consecutive days.
Amiloride
Amiloride tablet 20 mg two times daily (morning and afternoon) for two consecutive days.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Standardized salt diet
200 mmol NaCl per day given as three meals daily for 4 consecutive days.
Amiloride
Amiloride tablet 20 mg two times daily (morning and afternoon) for two consecutive days.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* Receiving amiloride, glucocorticoids, aldosterone or spironolactone
* Clinically relevant organic or systemic disease including malignancy
18 Years
90 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Odense University Hospital
OTHER
Region of Southern Denmark
OTHER
The Ministry of Science, Technology and Innovation, Denmark
OTHER_GOV
Danish Heart Foundation
OTHER
University of Southern Denmark
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Henrik Andersen, MD
MD, PhD student
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Henrik Andersen, MD
Role: PRINCIPAL_INVESTIGATOR
University of Southern Denmark
Jan Erik Henriksen, MD, PhD
Role: STUDY_DIRECTOR
Odense University Hospital
Claus Bistrup, MD, PhD
Role: STUDY_DIRECTOR
Odense University Hospital
Boye L Jensen, MD, PhD
Role: STUDY_DIRECTOR
University of Southern Denmark
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cardiovascular and Renal Research
Odense, , Denmark
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Svenningsen 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.
Saha 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.
Buhl 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.
Isaksson 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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
13-04-R94-A4513-22770
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2013-052
Identifier Type: -
Identifier Source: org_study_id