Kidney Transplant; ComplicationsNCT03036748
Increased Activity of ENaC in Proteinuric Kidney Transplant Recipients
A study testing Standardized sodium diet and Tbl amiloride in people with Kidney Transplant; Complications, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
The aim of this study is to determine if amiloride, a diuretic drug, is capable of increasing renal salt excretion, lowering blood pressure and inhibiting uPA in kidney transplant recipients with proteinuria compared to normoalbuminuric transplant patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Kidney Transplant; Complications
- What is being tested?
- Standardized sodium diet and Tbl amiloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2017to 1 Sep 2021
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- One Group of kidney transplant recipients with ACR< 30mg/g
- One Group of kidney transplant recipients with ACR >300mg/g
Who cannot join
- Treatment with amiloride, spironolactone, aldosterone- or analogs or tranexamsyre
- Pregnancy
- Clinically relevant organic or systemic disease including malignancy
- eGFR or creatinin-clearance < 30ml/min
- hyperkalemia (s-potassium > 5,0mmol/l)
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to determine if amiloride, a diuretic drug, is capable of increasing renal salt excretion, lowering blood pressure and inhibiting uPA in kidney transplant recipients with proteinuria compared to normoalbuminuric transplant patients.
- Conditions
- Kidney Transplant; Complications
- Being tested
- Standardized sodium diet, Tbl amiloride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized sodium dietDietary supplement
Also called Diet
Dietary Supplement: Standardized salt diet 150 mmol NaCl per day given as three meals daily for 5 consecutive days.
Tbl amilorideDrug
Also called Amiloride
Drug: Amiloride Amiloride tablet 10 mg two times daily (morning and afternoon) for one day
| Study group | Role | What they receive |
|---|---|---|
| TX control | Experimental | Kidney transplant recipients with urinary albumin/creatinin-ratio < 30mg/g Receives: Dietary Supplement: Standardized sodium diet; Drug: Tbl amiloride |
| TX Proteinuria | Experimental | Kidney transplant recipients with urinary albumin/creatinin-ratio > 300mg/g Receives: Dietary Supplement: Standardized sodium diet; Drug: Tbl 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 (after 4 days of standadized sodium diet) excretion at 24 hours after amiloride administration
Secondary outcomes (1)
Office or 24h 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 posted30 Jan 2017 (estimated)
- Study start1 Jan 2017
- Primary completion1 Sep 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney Transplant; ComplicationsStudies 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
- Model description
- Experimental: Kidney transplant recipients with ACR \> 300mg/g receiving standardized sodium diet (150 mmol NaCl/day) for 5 days and amiloride tablet 10 mg two times daily (morning and afternoon) on the last day. Interventions:◦Dietary Supplement: Standardized salt diet ◦Drug: Amiloride •Experimental: Kidney transplant recipient with ACR\< 30mg/g (Control) receiving a standardized salt diet (150 mmol NaCl/day) for 5 days, then amiloride tablet 10 mg two times daily (morning and afternoon) for 1 day. Interventions:◦Dietary Supplement: Standardized salt diet ◦Drug: Amiloride
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital, Region of Southern Denmark
- Responsible party
- Principal investigator, Gitte Rye Hinrichs, University of Southern Denmark
- Investigators
- Gitte Rye Hinrichs, MD, PHD, Principal investigator, Cardiovascular and Renal research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03036748
- Sponsor's protocol ID
- ENaC activation
- Status last verified
- Dec 2022
- First submitted
- 26 Jan 2017
- Last updated
- 27 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38254266
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increased Activity of ENaC in Proteinuric Kidney Transplant Recipients
- ClinicalTrials.gov ID
- NCT03036748
- Acronym / sponsor ID
- ENaC activation
- Conditions
- Kidney Transplant; Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Odense University Hospital, Region of Southern Denmark
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 30 Jan 2017 (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 aim of this study is to determine if amiloride, a diuretic drug, is capable of increasing renal salt excretion, lowering blood pressure and inhibiting uPA in kidney transplant recipients with proteinuria compared to normoalbuminuric transplant patients.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Experimental: Kidney transplant recipients with ACR > 300mg/g receiving standardized sodium diet (150 mmol NaCl/day) for 5 days and amiloride tablet 10 mg two times daily (morning and afternoon) on the last day. Interventions:◦Dietary Supplement: Standardized salt diet ◦Drug: Amiloride •Experimental: Kidney transplant recipient with ACR< 30mg/g (Control) receiving a standardized salt diet (150 mmol NaCl/day) for 5 days, then amiloride tablet 10 mg two times daily (morning and afternoon) for 1 day. Interventions:◦Dietary Supplement: Standardized salt diet ◦Drug: Amiloride
| Arm | Type | Receives |
|---|---|---|
| TX control | Experimental | Dietary Supplement: Standardized sodium diet, Drug: Tbl amilorideKidney transplant recipients with urinary albumin/creatinin-ratio < 30mg/g |
| TX Proteinuria | Experimental | Dietary Supplement: Standardized sodium diet, Drug: Tbl amilorideKidney transplant recipients with urinary albumin/creatinin-ratio > 300mg/g |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- One Group of kidney transplant recipients with ACR< 30mg/g
- One Group of kidney transplant recipients with ACR >300mg/g
Key exclusion criteria (5 listed)
- Treatment with amiloride, spironolactone, aldosterone- or analogs or tranexamsyre
- Pregnancy
- Clinically relevant organic or systemic disease including malignancy
- eGFR or creatinin-clearance < 30ml/min
- hyperkalemia (s-potassium > 5,0mmol/l)
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 sodium dietAlso: DietDietary Supplement: Standardized salt diet 150 mmol NaCl per day given as three meals daily for 5 consecutive days. | Dietary supplement | TX Proteinuria, TX control |
| Tbl amilorideAlso: AmilorideDrug: Amiloride Amiloride tablet 10 mg two times daily (morning and afternoon) for one day | Drug | TX Proteinuria, TX control |
Primary outcome
24-hour urinary sodium excretion induced by amiloride
Time frame: Change from baseline urinary sodium (after 4 days of standadized sodium diet) excretion at 24 hours after amiloride administration
1 secondary outcome
Office or 24h 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
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 27 Dec 2022.
- 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.
Related trials for Kidney Transplant; Complications
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
RecruitingObservational study
Cardiovascular Risk Assessment For Kidney Transplantation - Utility of Computed Tomography Coronary Angiography in the Assessment of Patients Awaiting Kidney Transplantation
Cardiovascular Diseases, Kidney Transplant; Complications
Not yet recruitingObservational study
Assessment of Perceived Stress in an Observational Study Evaluating a Biopsy-sparing Surveillance Strategy in Kidney Transplant Recipients With Blood and Urinary Biomarkers Predictive of the Absence of Rejection
Renal Transplantation; Complication, Renal Transplant
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
RecruitingPhase 1/2
Phase I/II Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Patients With Autoimmune Disorders
Autoimmune Disorders, Systemic Sclerosis
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.
Gitte Rye Hinrichs, MD, PHD principal investigator
Cardiovascular and Renal research
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 sodium diet and Tbl amiloride in people with Kidney Transplant; Complications, 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 2 inclusion and 5 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 27 Dec 2022. 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?
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?
24-hour urinary sodium excretion induced by amiloride (time frame: Change from baseline urinary sodium (after 4 days of standadized sodium diet) 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 NCT03036748, which also lists 1 linked publication.
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 27 Dec 2022.