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Clinical Trial Details

Trial ID: L4972
Source ID: NCT04983979
Associated Drug: Sodium Zirconium Cyclosilicate
Title: The ORTIZ Study: Optimising RASi Therapy With SZC
Acronym: ORTIZ
Status: TERMINATED
Study Results: NO
Results:
Conditions: CKD|Diabetes Mellitus, Type 2|Hyperkalemia
Interventions: DRUG: Sodium Zirconium Cyclosilicate|DRUG: Placebo
Outcome Measures: Primary: Proportion of patients on Maximum dose (300mg) Irbesartan therapy at 12 weeks compared to placebo, Proportion of patients on Maximum dose (300mg) Irbesartan therapy at 12 weeks compared to placebo, week 12 | Secondary: Change in potassium from baseline at each time point, Change in potassium from baseline at each study visit (week 1, week 2, 4,6,8,12), at each study visit (week 1, week 2, 4,6,8,12)|Frequency of adverse events, Safety, assessed at each study visit (week 1, week 2, 4,6,8,12)|Proportion of patients who have a potassium of >6mmol/l, or >6.5mmol/l at any time during the study •, Proportion of patients who have a potassium of \>6mmol/l,, or \>6.5mmol/l at any time during the study, Assessed at each study visit (week 1, week 2, 4,6,8,12)|Proportion of patients who have a potassium of <3.5mmol/l •, Proportion of patients who have a potassium of \<3.5mmol/l, assessed at each study visit (week 1, week 2, 4,6,8,12), Assessed at each study visit (week 1, week 2, 4,6,8,12)|Proportion of patients whose Glomerular filtration rate (GFR) falls by >30% from the previous visit •, Proportion of patients whose GFR falls by \>30% from the previous visit, Change in potassium from one visit to the next. Assessed at each study visit (week 1, week 2, 4,6,8,12)|Change in GFR at the end of study from baseline, Change in GFR at the end of study from baseline, Between baseline and week 12
Sponsor/Collaborators: Sponsor: Barts & The London NHS Trust
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 10
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2022-06-17
Completion Date: 2023-05-16
Results First Posted:
Last Update Posted: 2023-08-16
Locations: Kieran Mccafferty, London, Uk, E1 1BB, United Kingdom
URL: https://clinicaltrials.gov/show/NCT04983979