ACTRN12617001187336
Terminated
Phase 2
A physician-initiated double-blind, randomised, placebo-controlled , phase 2 study evaluating the efficacy and safety of inhibition of NADPH Oxidase with the first-in-class Nox-1/4 inhibitor, GKT137831, in adults with type 1 diabetes and persistently elevated urinary albumin excretion.
Overview
- Phase
- Phase 2
- Status
- Terminated
- Enrollment
- 83
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (—)
- Sex
- All
Inclusion Criteria
- •1\.Capable of understanding the content of and able voluntarily to provide a personally signed and dated written informed consent form.
- •2\.Stated willingness to comply with all study procedures and availability for the duration of the study.
- •3\.Male or female, aged 18\-70 years inclusive.
- •4\.Clinical diagnosis of type 1 diabetes, defined as at least 2 out of 3 of the following: (i) age of onset \< 40 years, (ii) insulin commenced within 1 year of the diagnosis of diabetes, (iii) positive autoantibodies for at least 1 of the antibodies associated with type 1 diabetes (islet cell antibody \[ICA], insulin autoantibody \[IAA], tyrosine phosphatase–like insulinoma antigen\-2 autoantibody \[IA\-2A], zinc transporter 8 autoantibody (ZnT8 A) and glutamic acid decarboxylase autoantibody \[GADA]).
- •5\.Established albuminuria, defined as an urine albumin to creatinine ratio (UACR) greater than or equal to 2\.5 mg/mmol in men or greater than or equal to 3\.5 mg/mmol in women, with
- •(a)the most recent UACR to have been within the albuminuria range and collected within the 12 months before Visit 1, AND
- •(b)at least one other UACR within the albuminuria range in the last 24 months before Visit 1, AND
- •(c)with not more than 1 normal UACR (i.e. \<2\.5 mg/mmol in men or \<3\.5 mg/mmol in women) in the 24 months before Visit 1, AND
- •(d)the geometric mean of the 2 UACR tests collected at Visit 1 is in the albuminuria range, greater or equal to 2\.5 mg/mmol in men or greater or equal to 3\.5 mg/mmol in women.
- •6\.eGFR greater or equal to 40 mL/min/1\.73 m2, as calculated by the CKD\-EPI creat formula, at Visit 1\.
Exclusion Criteria
- •1\.History of type 2 diabetes.
- •2\.HbA1c at Visit 1 greater or equal to 10\.0% (greater or equal to 86 mmol/mol).
- •3\.Chronic kidney disease due to a documented history of non\-diabetic kidney disease(s), except for hypertensive nephropathy, which is acceptable. Therefore, the chronic kidney disease must be due to diabetic kidney disease, with or without hypertensive kidney disease.
- •a.Diagnostic or interventional procedure requiring a contrast agent within 4 weeks of the first screening visit.
- •b.Untreated urinary tract infection at Visit 1 that would impact urinary protein levels.
- •c.History of renal transplant or other solid organ transplant, or planned renal transplant or other solid organ transplant during the study.
- •d.A history of acute renal dialysis or acute kidney injury (defined according to the Kidney Disease: Improving Global Outcomes \[KDIGO] definition) within 13 weeks of Visit 1\.
- •4\.Body mass index (BMI) \<18\.5 kg/m2 or \>40 kg/m2\.
- •5\. eGFR \<40 ml/min/1\.73m2, as calculated by the CKD\-EPI creat formula.
- •6\.Alteration in anti\-hypertensive therapy within 13 weeks prior to Visit 1, including change in dosing with ACEI or ARB.
Investigators
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