Increased Activity of ENaC in Proteinuric Kidney Transplant Recipients

Kidney Transplant; Complications Clinical Trial

Official title:

Increased Activity of ENaC in Proteinuric Kidney Transplant Recipients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03036748
• Other study ID #: ENaC activation
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: September 1, 2021

Study information

• Verified date: December 2022
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: September 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Kidney Transplant; Complications

Intervention

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

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

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense

Sponsors (3)

Lead Sponsor	Collaborator
University of Southern Denmark	Odense University Hospital, Region of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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