Nephrotic syndrome
Conditions
Interventions
Trade Name: Modamide 5 mg tablet
Pharmaceutical Form: Tablet
INN or Proposed INN: AMILORIDE
CAS Number: 2609-46-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Sponsors
University Hospital Tuebingen
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: 1. Plasma Creatinine > 1,5 mg/dl or acute kidney injury KDIGO stage 2 or 3 2. Hypotension, systolic blood pressure 4.8 mmol/l 4. Hypokalemia, plasma potassium concentration 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Objective of the study is to prove the efficacy and superiority of amiloride for reduction of edema and overhydration in human nephrotic syndrome in comparison to standard medication with furosemide. ;Secondary Objective: Not applicable.;Primary end point(s): Decrease of overhydration (OH) after 8 days, compared to baseline. OH is measured using bioimpedance spectroscopy with the device Body Composition Monitor (Fresenius Medical Care AG & Co; BCM), and expressed as percent of extracellular water (% ECW).;Timepoint(s) of evaluation of this end point: After 8 days of study medication. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Decrease of OH after 16 days 2. Decrease of body weight after 8 and 16 days 3. Decrease of edema circumference after 8 and 16 days 4. Decrease of systolic and diastolic blood pressure after 8 and 16 days 5. Increase of urine volume and natriuresis after 8 and 16 days 6. Course of plasma renin activity and serum aldosterone concentration after 8 and 16 days 7. Number of required changes of dose of study medication 8. Need for co-medication with HCT after 8 days 9. Occurrence of adverse events;Timepoint(s) of evaluation of this end point: After 8 and 16 days of study medication. | — |
Countries
Germany
Contacts
Public ContactSecretary's office Dep. Int.Med. IV
Univerity Hospital Tuebingen
Outcome results
None listed