Healthy diet containing fruits, vegetables and nuts to patients with renal insufficiency thought the use of potassium binder (sodium zirconium cyclosilicate): A Study Test

Phase 1

• Conditions: Chronic kidney disease, stages 4 and 5 of the disease; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2020-000695-38-SE
• Lead Sponsor: Karolinska Universitetssjukhuset

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-05
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 36

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

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 < 3.0 mmol/l at any visit;
5. Likely to start dialysis within 2 months according to the clinical judgment from the nephrologist;
6. Presence of inflammatory bowel syndrome;
7. Lack of fluence in the Swedish language;
8. Known hypersensitivity to SZC;
9. Known history of drug or alcohol abuse within 1 year of screening;
10. For women only - currently pregnant (confirmed with positive pregnancy test) or breast feeding;
11. History of QT prolongation associated with other medications that required discontinuation of that medication;
12. Congenital long QT syndrome;
13. Symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Subjects with atrial fibrillation controlled by medication are permitted;
14. History of QT-prolongation: QTc(f) > 550 msec or uncontrolled atrial fibrillation.

Study & Design

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