Increased Activity of ENaC in Proteinuric Kidney Transplant Recipients

Not Applicable

Completed

• Conditions: Kidney Transplant; Complications
• Interventions: Dietary Supplement: Standardized sodium diet; Drug: Tbl amiloride

• Registration Number: NCT03036748
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2017-01-26
• Study First Submitted QC: 2017-01-26
• Study First Posted: 2017-01-30
• Primary Completion: 2021-09-01
• Study Completion: 2021-09-01
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-23
• Last Update Posted: 2022-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TX Proteinuria	Tbl amiloride	Kidney transplant recipients with urinary albumin/creatinin-ratio \> 300mg/g
TX control	Standardized sodium diet	Kidney transplant recipients with urinary albumin/creatinin-ratio \< 30mg/g
TX control	Tbl amiloride	Kidney transplant recipients with urinary albumin/creatinin-ratio \< 30mg/g
TX Proteinuria	Standardized sodium diet	Kidney transplant recipients with urinary albumin/creatinin-ratio \> 300mg/g

Primary Outcome Measures

Name	Time	Method
24-hour urinary sodium excretion induced by amiloride	Change from baseline urinary sodium (after 4 days of standadized sodium diet) excretion at 24 hours after amiloride administration

Secondary Outcome Measures

Name	Time	Method
Office or 24h blood pressure measurements	Change from baseline office blood pressure at day 4 of salt diet and at 24 hours after amiloride administration

Trial Locations

Locations (1)

Odense University Hospital; 🇩🇰 Odense, Denmark