Increased Activity of ENaC in Proteinuric Kidney Transplant Recipients

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03036748

Enrollment

Registered

2017-01-30

Start date

2017-01-01

Completion date

2021-09-01

Last updated

2022-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplant; Complications

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.

Interventions

DIETARY_SUPPLEMENTStandardized sodium diet

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

DRUGTbl amiloride

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Masking description

open label

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 5 days, then amiloride tablet 10 mg two times daily (morning and afternoon) for 1 day. Interventions:◦Dietary Supplement: Standardized salt diet ◦Drug: Amiloride

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026