| Trial ID: | L2362 |
| Source ID: | NCT04063930
|
| Associated Drug: |
Lokelma 5 Gm Powder For Oral Suspension
|
| Title: |
The Effect of Sodium Zirconium Cyclosilicate on Albuminuria in Patients With Type 2 Diabetes and Hyperkalemia
|
| Acronym: |
ZIRCUS
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus With Kidney Complications
|
| Interventions: |
DRUG: LOKELMA 5 GM Powder for Oral Suspension|DRUG: Placebos
|
| Outcome Measures: |
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|Urinary sodium, Change in urinary sodium levels (mmol per liter) in one 24h urine collection from baseline to end of treatment period, 12 weeks|Urinary potassium, Change in urinary potassium levels (mmol per liter) in one 24h urine collection from baseline to end of treatment period, 12 weeks | Other: Safety outcome - Adverse events, Total number of adverse events from baseline to end of treatment, 12 weeks|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
|
| Sponsor/Collaborators: |
Sponsor: Steno Diabetes Center Copenhagen | Collaborators: AstraZeneca|Zealand University Hospital
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
20
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2019-10
|
| Completion Date: |
2021-12
|
| Results First Posted: |
|
| Last Update Posted: |
2019-10-16
|
| Locations: |
Steno Diabetes Center Copenhagen, Gentofte, 2820, Denmark
|
| URL: |
https://clinicaltrials.gov/show/NCT04063930
|
