Chronic kidney disease, stages 4 and 5 of the disease
Conditions
Interventions
Trade Name: Lokelma
Product Name: Lokelma
Pharmaceutical Form: Powder for oral solution in sachet
Other descriptive name: SODIUM ZIRCONIUM CYCLOSILICATE
Concentration unit: g gram(s)
Concentration typ
Sponsors
Karolinska Universitetssjukhuset
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provision of signed informed consent prior to any study specific procedures; 2. Female and/or male patients; 3. Age between 18 to 85 years old; 4. Patients with chronic kidney disease under regular treatment at the outpatient clinic; 5. Glomerular filtration rate below 29 ml/min/1.73 m2 (stage 4 and 5 of the disease) and not on dialysis; 6. Plasma potassium = 5.1 mmol/L at baseline or patients using of sodium polystyrene sulfonate (SPS) 1 month prior to inclusion to decrease the potassium plasma levels who develops hyperkalemia after sodium polystyrene sulfonate is discontinued; 7. Negative pregnancy test (urine or serum) for female subjects of childbearing potential; 8. Female subjects must be 1 year post-menopausal, surgically sterile, or using an acceptable method of contraception (an acceptable method of contraception is defined as a barrier method in conjunction with a spermicide) for the duration of the study (from the time they sign consent) and for 3 months after the last dose of SZC to prevent pregnancy. In addition, oral contraceptives, approved contraceptive implant, long-term injectable contraception, intrauterine device, or tubal ligation are allowed. Oral contraception alone is not acceptable; additional barrier methods in conjunction with spermicide must be used. 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 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 6
Exclusion criteria
Exclusion criteria: 1. Use of other potassium-lowering agent then SPS (loop-diuretics not included); 2. Participation in another clinical study with an investigational product during the last 3 months prior to inclusion; 3. Plasma potassium > 6.5 mmol/L; 4. Plasma potassium 550 msec or uncontrolled atrial fibrillation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To test whether chronic kidney disease patients on stages 4 and 5 of the disease can be safely prescribed a healthy diet with increased amount of potassium by concomitant use of potassium-lowering medication SZC to show improvements in patient´s satisfaction, symptoms and adherence to the target energy and protein recommendations.;Secondary Objective: Investigate the impact of implementing a healthy diet rich in potassium - combined with use of potassium-lowering medication to maintain plasma potassium within 3.5 to 5.0 mmol/L - in controlling plasma potassium, improving quality of life, ameliorating intestinal obstipation, maintain the dosage antihypertensives with blockade of renin-angiotensin-aldosterone system, diminishing inflammation, better control of phosphate and p-carbon dioxide levels and leading to a more healthy microbiota.;Primary end point(s): 1. Patient satisfaction: based on Renal Treatment Satisfaction Questionnaire (RTSQ). 2. Symptoms: based on the symptoms list. 3. Adherence to the dietary protein and energy targets: based on the 24-hour food recalls. ;Timepoint(s) of evaluation of this end point: The following timepoints are the same for all primary endpoints: Baseline (Week 0), Week 3 (Beginning of healthy diet), Week 6 (End of Study, End of healthy Diet) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Changes in plasma potassium 2. % patients with normokalemia, defined as potassium 3.5-5.0 mmol/L 3. Quality of life parameters: based on the RAND Short Form Health Survey (SF-36) 4. Improvement of intestinal obstipation: based on the ROMA III questionnaire and Bristol stool score; 5. Changes in inflammatory markers (C-reactive protein and interleukin-6), phosphate, P-carbon dioxide. 6. Reduction of circulating levels of microbiota-derived uremic retention solutes, such as indoxyl-sulfate, p-cresyl sulfate and trimethylamine N-oxide. 7. Maintaining the desired level of dosage of ACEIs and ARBs;Timepoint(s) of evaluation of this end point: The following timepoints are the same for all secondary endpoints: Baseline (Week 0), Week 3 (End of stabilization phase and beginning of healthy diet phase), Week 6 (End of Study, End of healthy Diet). Potassium will assessed also after 48h of baseline, after 48 hours Starting Week 3 and in week 2 and week 5. | — |
Countries
Sweden
Contacts
Public ContactPrincipal Investigator
Karolinska Institutet
Outcome results
None listed