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

NCT ID: NCT04063930

Last Updated: 2019-10-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-31
• Study Completion Date: 2021-12-31

Brief 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.

Detailed Description

Patients with type 2 diabetes and nephropathy, especially patients with impaired kidney function, frequently encounter hyperkalemia as an adverse effect of RAAS blocking treatment. Consequently, RAAS blocking treatment is reduced or discontinued, which in turn impairs prognosis in terms of long-term renal and cardiovascular outcome. Not only can hyperkalemia as an adverse event lead to changes in RAAS blocking treatment, the presence of persistent potassium levels in the upper part of the normal range can impair the efficacy of the RAAS blocking treatment, another reason to expect a beneficial effect of Lokelma treatment.

The study is a multicentre (3 sites in Sweden (TBD), 2 sites in Denmark (Steno Diabetes Center Copenhagen and Zealand University Hospital, Roskilde), double-blind, randomized placebo-controlled, parallel study. The study drug is compared to matching placebo that cannot be distinguished from active drug. The treatment period is 12 weeks.

Conditions

Type 2 Diabetes Mellitus With Kidney Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Lokelma

Sodium zirconium cyclosilicate Lokelma® 5 g, powder (Astra Zeneca)

After initial dosing subjects will be instructed to take the study drug once daily in the morning, by oral administration after the powder has been dissolved in a glass of drinking water.

Duration: 12 weeks

Group Type: ACTIVE_COMPARATOR

LOKELMA 5 GM Powder for Oral Suspension

Intervention Type: DRUG

Sodium zirconium cyclosilicate (a hyperkalemia treatment)

Placebo

Matching placebo (indistinguishable from the active comparator)

After initial dosing subjects will be instructed to take the study drug once daily in the morning, by oral administration after the powder has been dissolved in a glass of drinking water.

Duration: 12 weeks

Group Type: PLACEBO_COMPARATOR

Placebos

Intervention Type: DRUG

Matching placebo

Interventions

LOKELMA 5 GM Powder for Oral Suspension

Sodium zirconium cyclosilicate (a hyperkalemia treatment)

Intervention Type: DRUG

Placebos

Matching placebo

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: collaborator

Zealand University Hospital

OTHER

Sponsor Role: collaborator

Steno Diabetes Center Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Steno Diabetes Center Copenhagen

Gentofte Municipality, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Peter Rossing, Professor

Role: CONTACT

peter.rossing@regionh.dk

0045 30913383

Facility Contacts

Peter Rossing, MD

Role: primary

peter.rossing@regionh.dk

Other Identifiers

2019-000595-42

Identifier Type: -

Identifier Source: org_study_id