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OpenTrials
Completed

NCT Number: NCT03036748

Increased Activity of ENaC in Proteinuric Kidney Transplant Recipients

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.

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Key information

Conditions

Kidney Transplant; Complications

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Odense University Hospital

Odense, 5000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Standardized sodium diet

Dietary Supplement

Dietary Supplement: Standardized salt diet 150 mmol NaCl per day given as three meals daily for 5 consecutive days.

Other names: Diet

Tbl amiloride

Drug

Drug: Amiloride Amiloride tablet 10 mg two times daily (morning and afternoon) for one day

Other names: Amiloride

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Collaborators

  • Odense University Hospital
  • Region of Southern Denmark

Registry information

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Jan 30, 2017
Registry last updated
Dec 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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