The Effect of Sodium Zirconium Cyclosilicate on Albuminuria in Patients With Type 2 Diabetes and Hyperkalemia

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

To investigate whether concomitant treatment with Lokelma can improve the efficacy of standard blockade of the renin-angiotensin system in patients with type 2 diabetes, diabetic nephropathy and hyperkalemia.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Steno Diabetes Center Copenhagen
• Collaborators: AstraZeneca; Zealand University Hospital

Criteria

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.