Status:
UNKNOWN
The Effect of Sodium Zirconium Cyclosilicate on Albuminuria in Patients With Type 2 Diabetes and Hyperkalemia
Lead Sponsor:
Steno Diabetes Center Copenhagen
Collaborating Sponsors:
AstraZeneca
Zealand University Hospital
Conditions:
Type 2 Diabetes Mellitus With Kidney Complications
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
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 hyper...
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 ...
Eligibility Criteria
Inclusion
- Provision of informed consent prior to any study specific procedures
- Female and/or male patients with type 2 diabetes aged 18-85 years
- Persistent macroalbuminuria (UACR ≥ 200 mg/g in at least two out of the three latest UACR measurements in subject history).
- 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.
- Documented hyperkalemia (plasma potassium ≥ 5.0 mmol/l) at least once in the 90 days prior to inclusion in the study.
- Negative pregnancy test (urine or serum) for female subjects of childbearing potential.
- 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
- Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site)
- Previous enrolment in the present study
- Use of potassium-lowering agent (loop-diuretics not included)
- Participation in another clinical study with an investigational product during the last 3 months prior to inclusion.
- Plasma potassium \< 3.5 mmol/l within the previous six months before inclusion.
- Known hypersensitivity to Lokelma
- Known history of drug or alcohol abuse within 1 year of screening
- Estimated glomerular filtration rate (eGFR) \<15 ml/min/1.73 m2 (calculated by CKD-EPI formula).
- History of long QT syndrome.
- For women only - currently pregnant (confirmed with positive pregnancy test) or breast feeding.
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04063930
Start Date
October 1 2019
End Date
December 1 2021
Last Update
October 16 2019
Active Locations (1)
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1
Steno Diabetes Center Copenhagen
Gentofte Municipality, Denmark, 2820