Randomized, controlled interventional trial to investigate the efficacy of amiloride for the treatment of edema in human nephrotic syndrome - Amiloride in nephrotic syndrome

niversity Hospital Tuebingen0 sites36 target enrollmentNovember 14, 2019

Overview

No summary available.

Registry

who.int

Start Date

November 14, 2019

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

niversity Hospital Tuebingen

•1\.Acute nephrotic syndrome with proteinuria \> 3 g/day and formation of edema.
•2\.Age \= 18 years at the time of signing the informed consent.
•3\.Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures.
•4\.Ability to adhere to the study visit schedule and other protocol requirements.
•5\.Subject (male or female) is willing to use highly effective methods of contraception.
•6\.Female Patients of childbearing potential (WOCBP) must agree to pregnancy testing within 7 days from first dosing of IMP.
•7\.Female Patients must agree to abstain from breastfeeding during study participation and 28 days after study drug discontinuation.
•8\.All subjects must agree not to share medication.
•Are the trial subjects under 18? no
•Number of subjects for this age range:

•1\.Plasma Creatinine \> 1,5 mg/dl or acute kidney injury KDIGO stage 2 or 3
•2\.Hypotension, systolic blood pressure \< 90 mmHg
•3\.Hyperkalemia, plasma potassium concentration \> 4\.8 mmol/l
•4\.Hypokalemia, plasma potassium concentration \< 3\.3 mmol/l
•5\.Hyponatremia, plasma sodium concentration \< 128 mmol/l
•6\.Hypercalcemia, ionized calcium \> 2\.0 mmol/l or total albumin corrected calcium \> 3\.0 mmol/
•7\.Signs of cardiac decompensation (orthopnoe, dyspnoe NYHA IV)
•8\.Hepatic coma or precoma
•9\.Symptoms of gout
•10\.Current therapy with potassium\-sparing diuretics (e.g. spironolactone) or potassium supplements