A Phase 1b open label study of the pharmacokinetics and safety of oral OCX063 in adults with chronic kidney disease
- Conditions
- Chronic kidney diseaseRenal and Urogenital - Kidney disease
- Registration Number
- ACTRN12623000732684
- Lead Sponsor
- OccuRx Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- All
- Target Recruitment
- 12
Have an estimated glomerular filtration rate (eGFR) greater than or equal to 20 and less than or equal to 60 millilites per minute per body surface area.
- Evidence of increased albuminuria for at least 3 months prior to Day 1
- Urinary albumin creatinine ratio greater than or equal to 30 mg/mmol, and/or urinary protein creatinine ratio greater than or equal to 50 milligrams per millimol
- If requiring treatment with an angiotensin-converting enzyme inhibitor (ACEi), angiotensin receptor blocker (ARB), or sodium-glucose cotransporter-2 (SGLT2) inhibitor, must be on a stable dose for at least the 4 weeks prior to Day 1, with the intent to remain on that dose during the study period.
- Have had a prior renal transplant, or likely to require renal transplant during the study period.
- Have Autosomal Dominant Polycystic Kidney Disease (ADPKD) or documented inflammatory conditions, including lupus nephritis, and anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (AAV)
- Uncontrolled arterial hypertension defined as average of 3 systolic blood pressure readings of greater than or equal to 170 millimetre of mercury (mmHg) or an average of 3 diastolic blood pressure greater than or equal to 110 mmHg,
- Peripheral vascular disease, chronic ulcers, or significant cardiovascular disease (e.g., congestive heart failure, cardiomyopathy, ischemic heart disease) or history of myocarditis or pericarditis.
- Surgery within the 3 months prior to Day 1 or planned during the study period.
- Chronic use (more than 14 continuous days) of any medication that may be associated with changes in immune function including, but not limited to, systemic corticosteroids exceeding 10 milligrams per day of prednisone equivalent, allergy injections, immunoglobulin, interferon, immunomodulators, cytotoxic drugs, or other similar or toxic drugs within 6 months of screening or planned during the study period.
- Have aspartate transaminase (AST), alanine transaminase (ALT), gamma-glutamyl transferase (GGT), lactate dehydrogenase (LDH), or bilirubin values above the upper limit of normal (ULN) or evidence of hepatic disease as determined by history of hepatic encephalopathy, history of oesophageal varices, or history of portacaval shunt.
- Haemoglobin less than 80 grams per litre, platelets less than 90 x 10^9 per litre, or neutrophil count less than 1.4 x 10^9 per litre.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pharmacokinetic (PK) profile of OCX063 including <br>•Peak plasma concentration (Cmax) of OCX063 obtained directly from the plasma concentration data without interpolation. <br>•Time to peak plasma concentration (tmax) of OCX063 obtained directly from the plasma concentration data without interpolation. <br>•Area under the concentration-time curve of OCX063 from time 0 to infinity (extrapolated) (AUC0-inf)<br>•Area Under the Plasma Concentration versus -Time Curve over a dosing interval (tau). Dosing interval is considered as actual time 24 hours (AUCtau)<br>•Accumulation ratio based on Cmax (RCmax)<br>•Accumulation ratio based on AUC (RAUC)[ PK samples will be collected predose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post doses on Day 1 (first dose), Day 14, and Day 28]
- Secondary Outcome Measures
Name Time Method Safety of OCX063 as assessed by occurrence and incidence of treatment emergent adverse events (TEAEs) <br>[ From first dose of study drug on Day 1 to End of Study (EoS) on Day 35<br><br>There are no expected TEAEs at this stage of development. TEAEs will be recorded and assessed by asking participants if they have experienced any and by direct observation during study visits];Safety of OCX063 as assessed by physical examination including vital signs (blood pressure measured by machine or manual sphygmomanometer, heart rate and respiratory rate by manual count, and temperature by thermometer)[ On Days 14, 28 and 35 of study compared to baseline (Day 1)];Safety of OCX063 as assessed by changes in blood tests including haematology, biochemistry, and coagulation[ On Days 14, 28, and 35 of study compared to baseline (Day 1)]