Renal ImpairmentPhase 1NCT04646889
Pharmacokinetic Study of AR882 in Subjects With Various Degrees of Renal Impairment
A Phase 1 study testing AR882 Single Dose and AR882 Multiple Dose in people with Renal Impairment, run by Arthrosi Therapeutics at 4 sites in 2 countries.
Trial summary
This is a 2-segment, multi-center, phase 1, open-label, study evaluating the pharmacokinetics and pharmacodynamics of AR882 in subjects with various degrees of renal impairment. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Impairment
- What is being tested?
- AR882 Single Dose and AR882 Multiple Dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 14 Jan 2021to 27 Jun 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All Subjects:
- Males and non-pregnant, non-lactating females
- Body weight no less than 50 kg
- sUA greater than or equal to 4.0 mg/dL
- Renal Impaired Subjects:
- History of chronic renal impairment (> 6 months)
Who cannot join
- All Subjects:
- Malignancy within 5 years, except for successfully treated basal or squamous cell carcinoma of the skin
- History of cardiac abnormalities
- Active peptic ulcer disease or active liver disease
- History of kidney stones
- Renal Impaired Subjects:
- Requires dialysis
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States2 sites
Arthrosi Investigative Site
Dallas, Texas, 75230
Arthrosi Investigative Site
Orlando, Florida, 32809
New Zealand2 sites
Arthrosi Investigative Site
Auckland
Arthrosi Investigative Site
Christchurch
About this study
Official title: A Phase 1, Pharmacokinetic and Pharmacodynamic Study of AR882 in Adult Volunteers With Various Degrees of Renal Impairment
This is a 2-segment, multi-center, phase 1, open-label, study evaluating the pharmacokinetics and pharmacodynamics of AR882 in subjects with various degrees of renal impairment.
- Conditions
- Renal Impairment
- Being tested
- AR882 Single Dose, AR882 Multiple Dose
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AR882 Single DoseDrug
A single dose of AR882
AR882 Multiple DoseDrug
AR882 taken once daily for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Renal Impairment | Experimental | Subjects with various degrees of renal impairment Receives: Drug: AR882 Single Dose; Drug: AR882 Multiple Dose |
| Normal Renal Function | Experimental | Subjects with normal renal function Receives: Drug: AR882 Single Dose; Drug: AR882 Multiple Dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve (AUC) for plasma following a single dose of AR882 in subjects with renal impairment and normal renal function
Measured: 6 days
Time to maximum plasma concentration (Tmax) following a single dose of AR882 in subjects with renal impairment and normal renal function
Measured: 6 days
Maximum plasma concentration (Cmax) following a single dose of AR882 in subjects with renal impairment and normal renal function
Measured: 6 days
Terminal half-life (t 1/2) following a single dose of AR882 in subjects with renal impairment and normal renal function
Measured: 6 days
Amount excreted (Ae) into urine following a single dose of AR882 in subjects with renal impairment and normal renal function
Measured: 6 days
Renal clearance (CLr) following a single dose of AR882 in subjects with renal impairment and normal renal function
Measured: 6 days
AUC for plasma following multiple doses of AR882 in subjects with renal impairment and normal renal function
Measured: 15 days
Tmax following multiple doses of AR882 in subjects with renal impairment and normal renal function
Measured: 15 days
Cmax following multiple doses of AR882 in subjects with renal impairment and normal renal function
Measured: 15 days
t 1/2 following multiple doses of AR882 in subjects with renal impairment and normal renal function
Measured: 15 days
Secondary outcomes (2)
Incidence of Adverse Events, changes in laboratory, electrocardiogram, and vital signs following a single dose of AR882 in subjects with renal impairment and normal renal function
Measured: 14 days
Incidence of Adverse Events, changes in laboratory, electrocardiogram, and vital signs following multiple doses of AR882 in subjects with renal impairment and normal renal function
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2020
- Study start14 Jan 2021
- Primary completion27 Jun 2022
- Study completion27 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arthrosi Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IQVIA Pty Ltd
- Responsible party
- Sponsor
- Investigators
- Vijay Hingorani, MD, PhD, MBA, Study director, Arthrosi Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04646889
- Sponsor's protocol ID
- AR882-104
- Status last verified
- Aug 2022
- First submitted
- 18 Nov 2020
- Last updated
- 5 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Pharmacokinetic and Pharmacodynamic Study of AR882 in Adult Volunteers With Various Degrees of Renal Impairment
- ClinicalTrials.gov ID
- NCT04646889
- Acronym / sponsor ID
- AR882-104
- Conditions
- Renal Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Arthrosi TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- IQVIA Pty Ltd
- Study start
- 14 Jan 2021 (actual)
- Primary completion
- 27 Jun 2022 (actual)
- Study completion
- 27 Jun 2022 (actual)
- First posted
- 30 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 2-segment, multi-center, phase 1, open-label, study evaluating the pharmacokinetics and pharmacodynamics of AR882 in subjects with various degrees of renal impairment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Renal Impairment | Experimental | Drug: AR882 Single Dose, Drug: AR882 Multiple DoseSubjects with various degrees of renal impairment |
| Normal Renal Function | Experimental | Drug: AR882 Single Dose, Drug: AR882 Multiple DoseSubjects with normal renal function |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males and non-pregnant, non-lactating females
- Body weight no less than 50 kg
- sUA greater than or equal to 4.0 mg/dL
- History of chronic renal impairment (> 6 months)
Key exclusion criteria (7 listed)
- Malignancy within 5 years, except for successfully treated basal or squamous cell carcinoma of the skin
- History of cardiac abnormalities
- Active peptic ulcer disease or active liver disease
- History of kidney stones
- Requires dialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AR882 Single DoseA single dose of AR882 | Drug | Normal Renal Function, Renal Impairment |
| AR882 Multiple DoseAR882 taken once daily for 14 days | Drug | Normal Renal Function, Renal Impairment |
Primary outcome
Area under the curve (AUC) for plasma following a single dose of AR882 in subjects with renal impairment and normal renal function
Time frame: 6 days
Time to maximum plasma concentration (Tmax) following a single dose of AR882 in subjects with renal impairment and normal renal function
Time frame: 6 days
Maximum plasma concentration (Cmax) following a single dose of AR882 in subjects with renal impairment and normal renal function
Time frame: 6 days
Terminal half-life (t 1/2) following a single dose of AR882 in subjects with renal impairment and normal renal function
Time frame: 6 days
Amount excreted (Ae) into urine following a single dose of AR882 in subjects with renal impairment and normal renal function
Time frame: 6 days
Renal clearance (CLr) following a single dose of AR882 in subjects with renal impairment and normal renal function
Time frame: 6 days
AUC for plasma following multiple doses of AR882 in subjects with renal impairment and normal renal function
Time frame: 15 days
Tmax following multiple doses of AR882 in subjects with renal impairment and normal renal function
Time frame: 15 days
Cmax following multiple doses of AR882 in subjects with renal impairment and normal renal function
Time frame: 15 days
t 1/2 following multiple doses of AR882 in subjects with renal impairment and normal renal function
Time frame: 15 days
2 secondary outcomes
Incidence of Adverse Events, changes in laboratory, electrocardiogram, and vital signs following a single dose of AR882 in subjects with renal impairment and normal renal function
Time frame: 14 days
Incidence of Adverse Events, changes in laboratory, electrocardiogram, and vital signs following multiple doses of AR882 in subjects with renal impairment and normal renal function
Time frame: 21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
- Individual participant dataSharing planned: No
Related trials for Renal Impairment
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vijay Hingorani, MD, PhD, MBA study director
Arthrosi Therapeutics
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AR882 Single Dose and AR882 Multiple Dose in people with Renal Impairment, run by Arthrosi Therapeutics at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the curve (AUC) for plasma following a single dose of AR882 in subjects with renal impairment and normal renal function (time frame: 6 days). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2022.