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ORTIZ: SZC for RASi Optimisation in Diabetic Kidney Disease
NCT04983979Phase 2
Key facts
- Status
- Terminated
- Start
- Jun 2022
- Primary completion
- Mar 2023
- Countries
- 1
- Sponsor
- Barts Health NHS Trust
- Modality
- DNA Intercalators/Alkylators
- Conditions
- hyperkalemia
01
Overview
Phase 2, randomised, double-blind trial in hyperkalemia comparing SZC Arm with Placebo Arm (2 arms). Primary endpoint: Proportion of Patients on Maximum Dose (300mg) Irbesartan Therapy at 12 weeks. Started Jun 2022; status: terminated.
02
Design
2 arms- Study design
- RandomizedDouble-blind
SZC Arm
Sodium Zirconium Cyclosilicate (5g or 10g OD) + Irbesartan titration.
Placebo Arm
Matched Placebo + Irbesartan titration.
03
Who it enrols
Adults with Type 2 Diabetes and CKD (eGFR 25-60) with albuminuria and hyperkalemia (or history thereof) on sub-maximal RASi therapy.
04
Endpoints
Primary
Proportion of Patients on Maximum Dose (300mg) Irbesartan Therapy
Secondary
Change in Potassium From Baseline
Change in the BP at the End of the Study From Baseline
Proportion of Patients Who Have a Potassium of >6mmol/l, or >6.5mmol/l
Proportion of Patients Who Have a Potassium of <3.5mmol/l
Proportion of Patients Whose Glomerular Filtration Rate (GFR) Falls by >30% From the Previous Visit
Change in GFR at the End of Study From Baseline
Frequency of Adverse Events
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