Increased Activity of ENaC in Proteinuric Kidney Transplant Recipients

Study Overview
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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.

Official Title
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Increased Activity of ENaC in Proteinuric Kidney Transplant Recipients

Conditions
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Kidney Transplant; Complications

Intervention / Treatment
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* Dietary Supplement: Standardized sodium diet
* Drug: Tbl amiloride


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TX control<br>Kidney transplant recipients with urinary albumin/creatinin-ratio < 30mg/g | Dietary Supplement: Standardized sodium diet<br>* Dietary Supplement: Standardized salt diet 150 mmol NaCl per day given as three meals daily for 5 consecutive days.<br>* Other names: Diet;Drug: Tbl amiloride<br>* Drug: Amiloride Amiloride tablet 10 mg two times daily (morning and afternoon) for one day<br>* Other names: Amiloride;|
| Experimental: TX Proteinuria<br>Kidney transplant recipients with urinary albumin/creatinin-ratio > 300mg/g | Dietary Supplement: Standardized sodium diet<br>* Dietary Supplement: Standardized salt diet 150 mmol NaCl per day given as three meals daily for 5 consecutive days.<br>* Other names: Diet;Drug: Tbl amiloride<br>* Drug: Amiloride Amiloride tablet 10 mg two times daily (morning and afternoon) for one day<br>* Other names: Amiloride;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 |