Increased Activity of ENaC in Proteinuric Kidney Transplant Recipients

NCT03036748 | Completed

• 1 other identifier: ENaC activation
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Transplant; Complications

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

TX control

EXPERIMENTAL

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

Dietary Supplement: Standardized sodium diet; Drug: Tbl amiloride

TX Proteinuria

EXPERIMENTAL

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

Dietary Supplement: Standardized sodium diet; Drug: Tbl amiloride

Interventions

Standardized sodium diet DIETARY_SUPPLEMENT

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

Also known as: Diet

TX Proteinuria; TX control

Tbl amiloride DRUG

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

Also known as: Amiloride

TX Proteinuria; TX control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• One Group of kidney transplant recipients with ACR\< 30mg/g
• One Group of kidney transplant recipients with ACR \>300mg/g

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Southern Denmark: lead
• Odense University Hospital: collaborator
• Region of Southern Denmark: collaborator

Study Sites (1)

Odense University Hospital

Odense, 5000, Denmark

Location

Related Publications (1)

• Isaksson GL, Hinrichs GR, Andersen H, Bach ML, Weyer K, Zachar R, Henriksen JE, Madsen K, Lund IK, Mollet G, Bistrup C, Birn H, Jensen BL, Palarasah Y. Amiloride Reduces Urokinase/Plasminogen-Driven Intratubular Complement Activation in Glomerular Proteinuria. J Am Soc Nephrol. 2024 Apr 1;35(4):410-425. doi: 10.1681/ASN.0000000000000312. Epub 2024 Jan 23.

  PMID: 38254266 DERIVED

MeSH Terms

Interventions

Diet; Amiloride

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Gitte Rye Hinrichs, MD, PHD

  Cardiovascular and Renal research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: open label
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: 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

Study Record Dates

• First Submitted: January 26, 2017
• First Posted: January 30, 2017
• Study Start: January 1, 2017
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: December 27, 2022

Record last verified: 2022-12

Locations

DK (1)