The ORTIZ Study: Optimising RASi Therapy With SZC

• Status: Not yet recruiting
• Trial end date: 2022-08-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Barts & The London NHS Trust

Criteria

Inclusion Criteria:

1. Able and willing to provide written informed consent

2. Adults ≥ 18years old

3. Type 2 Diabetes

4. CKD defined as eGFR 25-60ml/min

5. Albuminuria with uACR measured at >33.9.mg/mmol (300mg/g)

6. On a stable (>4 weeks) of sub-maximal RASi dose, defined as any ACE or ARB dose up to and including 50% of maximum dose with evidence of hyperkalaemia potassium level >5.0mmol/l OR not currently on RASi therapy due to documented issues of hyperkalaemia in the past necessitating RASi discontinuation

Exclusion Criteria:

1. Active malignancy

2. Patients who lack capacity to give informed consent

3. GI disturbance/chronic diarrhoea/stoma

4. Subjects with a life expectancy of less than 3 months.

5. Women who are pregnant, lactating, planning to become pregnant or unwilling to use effective methods of contraception during the study.

6. Presence of any condition which, in the opinion of the investigator, places the subject at undue risk or potentially jeopardizes the quality of the data to be generated including NYHA class III/IV.

7. History of acute eGFR fall with RASi therapy (>30% in eGFR on initiation of RASi therapy)

8. Known hypersensitivity or previous anaphylaxis to SZC or Irbesartan

9. Hypotension: BP <120/70mm/hg at screening despite no antihypertensive agent use

10. Uncontrolled Blood pressure: BP >170/110 at screening

11. Evidence of prolonged QT on ECG QTc(f)>550msec

12. History of QT prolongation associated with other medications that required discontinuation of that medication

13. Treatment with lithium, or dual blockade with ACEi and ARB or mineralocorticoid inhibitor

14. History of congenital long QT syndrome

15. Symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Subjects with atrial fibrillation controlled by medication are permitted

16. Current or recent (within 3 months) participation in a clinical trial involving an investigational medicinal product.

17. Current treatment with a potassium binder medication