Chronic kidney disease with albuminuria MedDRA version: 23.1 Level: PT Classification code 10064848 Term: Chronic kidney disease System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 21.1 Level: LLT Classification code 10020647 Term: Hyperkalemia System Organ Class: 100000004861 MedDRA version: 20.0 Level: PT Classification code 10001580 Term: Albuminuria System Organ Class: 10038359 - Renal and urinary disorders
Conditions
Interventions
Product Name: Spironolactone
Pharmaceutical Form: Tablet
INN or Proposed INN: SPIRONOLACTONE
CAS Number: 52-01-7
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 25-
Sponsors
Henrik Birn
Eligibility
Sex/Gender
All
Inclusion criteria
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
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) 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate if concomitant treatment with Patiromer will lead to a greater reduction in albuminuria when compared to treatment without Patiromer in patients with chronic kidney disease, albuminuria and a history of hyperkalemia. This is based on the notion, that concomitant treatment with the potassium binder Patiromer will allow for more intensive treatment with inhibitors of the renin-angiotensin-aldosterone system (Losartan and/or Spironolactone) leading to reduction in albuminuria being an established surrogate marker of the progression of chronic kidney disease. ;Secondary Objective: The study will further investigate, if concomitant treatment with Patiromer and a more intensive treatment with inhibitors of the renin-angiotensin-aldosterone system (Losartan and/or Spironolactone) in patients with chronic kidney disease, albuminuria and a history of hyperkalemia will lead to changes in blood pressure control, kidney function, plasma-potassium, intake of potentially healthy, potasium rich foods such as fruit and vegetables, quality of life as well as a number of markers of cardiovascular health including left ventricular ejection fraction, pulse wave velocity, and cardiovascular biomarkers, when compared to patients not treated with Patiromer. Furthermore, the study will assess the safety of concomitant treatment with Patiromer and a more intensive treatment with inhibitors of the renin-angiotensin-aldosterone system (losartan and/or spironolactone) by comparing the incidence of severe hyperkalemia and acute renal failure.;Primary end point(s): The difference in the change in albuminuria (urinary albumin/creatinine ratio) between patients assigned to treatment with Patiromer and patients not assigned to Patiromer as evaluated by the average of 2 morning spot urine samples.;Timepoint(s) of evaluation of this end point: From randomization to end of study (52 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. The difference in amount of albuminuria between the two groups evaluated by a spot urine sample and a 24h urine collection at the end of treatment. 2. The difference in the change of albuminuria between the two groups evaluated by a 24h urine collection from randomization to the end of trial 3. The difference in the extent of treatment with inhibitors of the renin-angiotensin-aldosterone-system (Losartan and/or Spironolactone) between the two groups at the end of trial. 4. The difference in the change of the extent of treatment with inhibitors of the renin-angiotensin-aldosterone-system (Losartan and/or Spironolactone) between the two groups from randomization to the end of trial. 5. The difference in renal function (eGFR and urine-creatinine-clearance) between the two groups and the end of treatment. 6. The difference in the change in renal function (eGFR and urine-creatinine-clearance) between the two groups from randomization to the end of treatment. 7. The difference in blood pressure (ambulatory and 24h) between the two groups at the end of treatment. 8. The difference in the change in blood pressure (ambulatory and 24h) between the two groups from randomization to the end of treatment. 9. The difference in pulse-wave-velocity between the two groups at the end of treatment. 10. The difference in the change in pulse-wave-velocity between the two groups from randomization to the end of treatment. 11. The difference in left-ventricular function (ejection fraction) between the two groups at the end of treatment. 12. The difference in the change in left-ventricular function (ejection fraction) between the two groups from randomization to the end of treatment. 13. The difference in cardiac biomarkers between the two groups at the end of treatment. 14. The difference in the change in cardiac biomarkers between the two groups from randomization to the end of treatment. 15. The difference in P-potassium between the two groups at the end | — |
Countries
Denmark
Contacts
Public ContactDept. of Renal Medicine, AUH
Henrik Birn
Outcome results
None listed