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 (ZIRCUS)

NCT04063930 Phase 4 UNKNOWN

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.

Details

Lead sponsor	Steno Diabetes Center Copenhagen
Phase	Phase 4
Status	UNKNOWN
Enrolment	20
Start date	2019-10
Completion	2021-12

Conditions

• Type 2 Diabetes Mellitus With Kidney Complications

Interventions

• LOKELMA 5 GM Powder for Oral Suspension
• Placebos

Primary outcomes

• Urinary albumin creatinine ratio (UACR) — 12 weeks
  Change in the geometric mean of UACR (milligram per gram) measured in three consecutive morning spot urine collections from baseline to end of treatment

Countries

Denmark