Increased Activity of ENaC in Proteinuric Kidney Transplant Recipients

December 23, 2022 updated by: Gitte Rye Hinrichs, University of Southern Denmark
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Odense, Denmark, 5000
        • Odense University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • One Group of kidney transplant recipients with ACR< 30mg/g
  • One Group of kidney transplant recipients with ACR >300mg/g

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TX control
Kidney transplant recipients with urinary albumin/creatinin-ratio < 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 Names:
  • Diet
Drug: Tbl amiloride
Drug: Amiloride Amiloride tablet 10 mg two times daily (morning and afternoon) for one day
Other Names:
  • Amiloride
Experimental: TX Proteinuria
Kidney transplant recipients with urinary albumin/creatinin-ratio > 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 Names:
  • Diet
Drug: Tbl amiloride
Drug: Amiloride Amiloride tablet 10 mg two times daily (morning and afternoon) for one day
Other Names:
  • Amiloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Change from baseline urinary sodium (after 4 days of standadized sodium diet) excretion at 24 hours after amiloride administration

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Change from baseline office blood pressure at day 4 of salt diet and at 24 hours after amiloride administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern Denmark

Collaborators

Odense University Hospital
Region of Southern Denmark

Investigators

  • Principal Investigator: Gitte Rye Hinrichs, MD, PHD, Cardiovascular and Renal Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

September 1, 2021

Study Completion (Actual)

September 1, 2021

Study Registration Dates

First Submitted

January 26, 2017

First Submitted That Met QC Criteria

January 26, 2017

First Posted (Estimate)

January 30, 2017

Study Record Updates

Last Update Posted (Actual)

December 27, 2022

Last Update Submitted That Met QC Criteria

December 23, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ENaC activation

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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