Measures to slow the progression of chronic kidney disease in patients with protein in the urine and elevated potassium in the blood

Phase 1

• Conditions: Chronic kidney disease with albuminuria; MedDRA version: 23.1Level: PTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 10038359 - Renal and urinary disorders; MedDRA version: 21.1Level: LLTClassification code 10020647Term: HyperkalemiaSystem Organ Class: 100000004861; MedDRA version: 20.0Level: PTClassification code 10001580Term: AlbuminuriaSystem Organ Class: 10038359 - Renal and urinary disorders; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2020-001595-15-DK
• Lead Sponsor: Henrik Birn

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-24
• Last Update Posted: 19 February 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

1.Age 18-80 years
2.eGFR 25-60 mL/min/1.73 m2
3.Latest P-potassium > 4.5 mmol/L or b) P-kalium > 4.5 mmol/L at least twice within the last 24 months
4.Urine albumin creatinine ratio > 500 mg/g or 200mg/g and diabetes

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 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

Exclusion Criteria

1.Intolerance or allergic to Losartan, Spironolactone or Patiromer
2.Previous renal transplant recipient or active on the waiting ling
3.End stage renal disease (defined as the need for dialysis or renal transplantation)
4.Any condition that currently or through the duration of the study would require specific immunosuppressive therapy
5.Pregnancy
6.Regular use of Trimethoprim and/or NSAIDs
7.Disseminated cancer disease
8.Addisons disease
9.History of heart failure defined as Ejection Fraction (EF) < 40% or currently receiving treatment at a heart failure clinic or similar
10.Porphyria
11.Severe constipation requiring daily and chronic use of laxatives and/or previous recurrent ileus (> 1 incident in the past 10 years without curative treatment
12.Fructose intolerance
13.Galactose intolerance
14.A history of severe liver insufficiency (Child–Pugh score B-C)
15. SGLT2-inhibitor treatment initated = 30 days prior to inclusion

Study & Design

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