Increased Activity of ENaC in Proteinuric Kidney Transplant Recipients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2021-09-01

Brief Summary

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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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Detailed Description

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Conditions

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Kidney Transplant; Complications

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

open label

Study Groups

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TX control

Kidney transplant recipients with urinary albumin/creatinin-ratio \< 30mg/g

Group Type EXPERIMENTAL

Standardized sodium diet

Intervention Type DIETARY_SUPPLEMENT

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

Tbl amiloride

Intervention Type DRUG

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

TX Proteinuria

Kidney transplant recipients with urinary albumin/creatinin-ratio \> 300mg/g

Group Type EXPERIMENTAL

Standardized sodium diet

Intervention Type DIETARY_SUPPLEMENT

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

Tbl amiloride

Intervention Type DRUG

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

Interventions

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Standardized sodium diet

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

Intervention Type DIETARY_SUPPLEMENT

Tbl amiloride

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

Intervention Type DRUG

Other Intervention Names

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Diet Amiloride

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No