Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000732684p
Ethics application status
Not yet submitted
Date submitted
20/06/2023
Date registered
5/07/2023
Date last updated
26/11/2023
Date data sharing statement initially provided
5/07/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase 1b open label study of the pharmacokinetics and safety of oral OCX063 in adults with chronic kidney disease
Scientific title
A Phase 1b open label study of the pharmacokinetics and safety of oral OCX063 in adults with chronic kidney disease
Secondary ID [1] 309871 0
OCC-OCX063-CKDPK
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic kidney disease 330323 0
Condition category
Condition code
Renal and Urogenital 327175 327175 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oral capsules of OCX063, to be taken in the morning on an empty stomach with water
- The first 6 participants will take 50 mg once daily for 28 days.
- The second 6 participants will take 100 mg once daily for 28 days
Depending on results from these 12 participants, an additional dose of either 25 mg or 75 mg may be studied. In that case 6 additional participants would take the selected dose once daily for 28 days.
Compliance will be monitored by review of a dosing diary and capsule count at each visit
Intervention code [1] 326295 0
Treatment: Drugs
Comparator / control treatment
None. Cohorts are not directly compared to each other
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335052 0
Pharmacokinetic (PK) profile of OCX063 including
• Peak plasma concentration (Cmax) of OCX063 obtained directly from the plasma concentration data without interpolation.
• Time to peak plasma concentration (tmax) of OCX063 obtained directly from the plasma concentration data without interpolation.
• Area under the concentration-time curve of OCX063 from time 0 to infinity (extrapolated) (AUC0-inf)
• Area Under the Plasma Concentration versus -Time Curve over a dosing interval (tau). Dosing interval is considered as actual time 24 hours (AUCtau)
• Accumulation ratio based on Cmax (RCmax)
• Accumulation ratio based on AUC (RAUC)
Timepoint [1] 335052 0
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 [1] 422868 0
Safety of OCX063 as assessed by occurrence and incidence of treatment emergent adverse events (TEAEs)
Timepoint [1] 422868 0
From first dose of study drug on Day 1 to End of Study (EoS) on Day 35

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
Secondary outcome [2] 422869 0
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)
Timepoint [2] 422869 0
On Days 14, 28 and 35 of study compared to baseline (Day 1)
Secondary outcome [3] 422871 0
Safety of OCX063 as assessed by changes in blood tests including haematology, biochemistry, and coagulation
Timepoint [3] 422871 0
On Days 14, 28, and 35 of study compared to baseline (Day 1)

Eligibility
Key inclusion criteria
- 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.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Company decision
Date of first participant enrolment
Anticipated
30/09/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 314054 0
Commercial sector/Industry
Name [1] 314054 0
OccuRx Pty Ltd
Country [1] 314054 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
OccuRx Pty Ltd
Address
Level 9, 31 Queen St
Melbourne VIC 3000
Country
Australia
Secondary sponsor category [1] 315958 0
None
Name [1] 315958 0
Address [1] 315958 0
Country [1] 315958 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 313191 0
St Vincent's Hospital HREC
Ethics committee address [1] 313191 0
St Vincent's Hospital Melbourne
41 Victoria Pde
Fitzroy VIC 3065
Ethics committee country [1] 313191 0
Australia
Date submitted for ethics approval [1] 313191 0
28/07/2023
Approval date [1] 313191 0
Ethics approval number [1] 313191 0

Summary
Brief summary
This is an open label study to measure the PK of oral OCX063, over 28 days of dosing in participants with chronic kidney disease (CKD). The study will be run in sequential cohorts, with the first 6 participants receiving a 50 mg dose of OCX063 per day and the following 6 participants receiving 100 mg OCX063 per day. An additional dose cohort of 25 mg or 75 mg may be added if PK data indicate that a lower dose may provide adequate exposure levels. Safety will also be assessed.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127294 0
Prof Eugenia Pedagogos
Address 127294 0
Sunshine Hospital
176 Furlong Rd
St Albans VIC 3021
Country 127294 0
Australia
Phone 127294 0
+61 417 309 472
Fax 127294 0
Email 127294 0
eugenia.pedagogos@wh.org.au
Contact person for public queries
Name 127295 0
Ms Nicole Kruger
Address 127295 0
OccuRx Pty Ltd
Level 9, 31 Queen St
Melbourne VIC 3000
Country 127295 0
Australia
Phone 127295 0
+61 425 846 036
Fax 127295 0
Email 127295 0
info@occurx.com
Contact person for scientific queries
Name 127296 0
Ms Nicole Kruger
Address 127296 0
OccuRx Pty Ltd
Level 9, 31 Queen St
Melbourne VIC 3000
Country 127296 0
Australia
Phone 127296 0
+61 425 846 036
Fax 127296 0
Email 127296 0
info@occurx.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
PK data not relevant to other parties


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.