ZIRCUSEfectos del Sodium Zirconium Cyclosilicate (Lokelma) sobre la albuminuria en pacientes con diabetes tipo 2 y hiperkalemia

Fecha de inicio: 1 de octubre de 2019

Inclusion Criteria: 1. Provision of informed consent prior to any study specific procedures 2. Female and/or male patients with type 2 diabetes aged 18-85 years 3. Persistent macroalbuminuria (UACR ≥ 200 mg/g in at least two out of the three latest UACR measurements in subject history). 4. Chronic (at least 1 month) stable RAAS blocking treatment, i.e maximum tolerated (individually defined by investigator) dose of an ACE inhibitor or ARB at time of inclusion. 5. Documented hyperkalemia (plasma potassium ≥ 5.0 mmol/l) at least once in the 90 days prior to inclusion in the study. 6. Negative pregnancy test (urine or serum) for female subjects of childbearing potential. 7. 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 Lokelma/matching placebo 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. Exclusion Criteria: 1. Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site) 2. Previous enrolment in the present study 3. Use of potassium-lowering agent (loop-diuretics not included) 4. Participation in another clinical study with an investigational product during the last 3 months prior to inclusion. 5. Plasma potassium \< 3.5 mmol/l within the previous six months before inclusion. 6. Known hypersensitivity to Lokelma 7. Known history of drug or alcohol abuse within 1 year of screening 8. Estimated glomerular filtration rate (eGFR) \<15 ml/min/1.73 m2 (calculated by CKD-EPI formula). 9. History of long QT syndrome. 10. For women only - currently pregnant (confirmed with positive pregnancy test) or breast feeding.