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NCT04063930 Clinical Trial

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

Type 2 Diabetes Mellitus With Kidney Complications Clinical Trial

— ZIRCUS  

Official title:
A Randomized, Double-blind, Placebo Controlled, Parallel, Multicenter Study of the Effects of 12-weeks of Sodium Zirconium Cyclosilicate (Lokelma) on Albuminuria (UACR) in Patients With Type 2 Diabetes and Hyperkalemia

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04063930
Other study ID # 2019-000595-42
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date October 2019
Est. completion date December 2021

Study information
Verified date October 2019
Source Steno Diabetes Center Copenhagen
Contact Peter Rossing, Professor
Phone 0045 30913383
Email peter.rossing@regionh.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date December 2021
Est. primary completion date December 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• LOKELMA 5 GM Powder for Oral Suspension
Sodium zirconium cyclosilicate (a hyperkalemia treatment)
• Placebos
Matching placebo

Locations
Country Name City State
Denmark Steno Diabetes Center Copenhagen Gentofte

Sponsors (3)
Lead Sponsor Collaborator
Steno Diabetes Center Copenhagen AstraZeneca, Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Other Safety outcome - Adverse events Total number of adverse events from baseline to end of treatment 12 weeks
Other Safety outcome - Electrocardiogram Number of adverse events related to changes in the electrocardiogram (e.g. QTc prolongation) from baseline to end of treatment 12 weeks
Primary Urinary albumin creatinine ratio (UACR) Change in the geometric mean of UACR (milligram per gram) measured in three consecutive morning spot urine collections from baseline to end of treatment 12 weeks
Secondary Estimated glomerular filtration rate (eGFR) Change in eGFR mL/min/1.73 m2 (CKD-EPI formula) from baseline to end of treatment 12 weeks
Secondary Urinary sodium Change in urinary sodium levels (mmol per liter) in one 24h urine collection from baseline to end of treatment period 12 weeks
Secondary Urinary potassium Change in urinary potassium levels (mmol per liter) in one 24h urine collection from baseline to end of treatment period 12 weeks