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Increased Activity of ENaC in Proteinuric Kidney Transplant Recipients

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ClinicalTrials.gov Identifier: NCT03036748
Recruitment Status : Recruiting
First Posted : January 30, 2017
Last Update Posted : March 21, 2019
Sponsor:
Collaborators:
Odense University Hospital
Region of Southern Denmark
Information provided by (Responsible Party):
Gitte Rye Hinrichs, University of Southern Denmark

Brief 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.

Condition or disease Intervention/treatment Phase
Kidney Transplant; Complications Dietary Supplement: Standardized sodium diet Drug: Tbl amiloride Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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 4 days, then amiloride tablet 20 mg two times daily (morning and afternoon) for 1 day.

Interventions:◦Dietary Supplement: Standardized salt diet

◦Drug: Amiloride

Masking: None (Open Label)
Masking Description: open label
Primary Purpose: Basic Science
Official Title: Increased Activity of ENaC in Proteinuric Kidney Transplant Recipients
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TX control
Kidney transplant recipients with ACR <30mg/g
Dietary Supplement: Standardized sodium diet
Dietary Supplement: Standardized salt diet 150 mmol NaCl per day given as three meals daily for 5 consecutive days.
Other Name: Diet

Drug: Tbl amiloride
Drug: Amiloride Amiloride tablet 10-20 mg two times daily (morning and afternoon) for one day
Other Name: Amiloride

Experimental: TX Proteinuria
Kidney transplant recipients with ACR> 300mg/g
Dietary Supplement: Standardized sodium diet
Dietary Supplement: Standardized salt diet 150 mmol NaCl per day given as three meals daily for 5 consecutive days.
Other Name: Diet

Drug: Tbl amiloride
Drug: Amiloride Amiloride tablet 10-20 mg two times daily (morning and afternoon) for one day
Other Name: Amiloride




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • One Group of kidney transplant recipients with ACR< 30mg/g
  • One Group of kidney transplant recipients with ACR >300mg/g
  • Negative pregnancy test at inclusion and taking contraceptive medication

Exclusion Criteria:

  • Receiving amiloride, glucocorticoids, aldosterone or spironolactone
  • Clinically relevant organic or systemic disease including malignancy
  • eGFR or creatinin-clearance < 30ml/min
  • hyperkalemia (s-potassium > 5,0mmol/l)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03036748


Contacts
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Contact: Gitte Rye Hinrichs, MD, PhD +45-21695186 ext 21695186 ghinrichs@health.sdu.dk
Contact: Claus Bistrup, MD, PhD Claus.bistrup@rsyd.dk

Locations
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Denmark
Odense University Hospital Recruiting
Odense, Denmark, 5000
Contact: Gitte Hinrichs, MD, PhD    21695186 ext 21695186    gitte@hinrichs.dk   
Sponsors and Collaborators
University of Southern Denmark
Odense University Hospital
Region of Southern Denmark
Investigators
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Principal Investigator: Gitte Rye Hinrichs, MD, PHD Cardiovascular and Renal research

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Responsible Party: Gitte Rye Hinrichs, Doctor, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT03036748     History of Changes
Other Study ID Numbers: ENaC activation
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Amiloride
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Acid Sensing Ion Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Epithelial Sodium Channel Blockers
Diuretics, Potassium Sparing