Clinical study on the efficacy of amiloride for the treatment of edema in nephrotic syndrome

Phase 1

• Conditions: ephrotic syndrome; Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]

• Registration Number: EUCTR2019-002607-18-DE
• Lead Sponsor: niversity Hospital Tuebingen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-14
• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

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:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 36
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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
11.Diuretic therapy in the last 48 hours before enrollment
12.Women during pregnancy and lactation
13.History of hypersensitivity to the investigational medicinal product, comparator or co-medication or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product, comparator or co-medication.
14.Any other clinical condition that would jeopardize the patient’s safety while participating in this clinical trial
15.Active participation in other clinical trials or observation period of competing trials.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified