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The ORTIZ Study: Optimising RASi Therapy With SZC

NCT04983979 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-06-08

Study results available
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Summary

The hypothesis is that 3 months' treatment with SZC versus placebo will enable RASi (Irbesartan) maximisation in a cohort of patients with diabetic kidney disease.

Conditions

  • CKD
  • Diabetes Mellitus, Type 2
  • Hyperkalemia

Interventions

DRUG

Sodium Zirconium Cyclosilicate

sachets of 5g or 10g given OD titrated to serum potassium

DRUG

Placebo

matched placebo given titrated according to potassium at a dose to 5 or 10g

Sponsors & Collaborators

  • Barts & The London NHS Trust

    lead OTHER

Principal Investigators

  • Keiran McCafferty · Barts & The London NHS Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-17
Primary Completion
2023-03-16
Completion
2023-05-16

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04983979 on ClinicalTrials.gov