End Stage Renal DiseasePhase 1NCT05065463
To Assess the Pharmacokinetics, Safety, and Tolerability of AZD8233 in Participants With Chronic Kidney Disease (CKD), End Stage Renal Disease (ESRD) and Healthy Participants.
A Phase 1 study testing AZD8233 in people with End Stage Renal Disease, run by AstraZeneca at 1 site in Poland.
Trial summary
The study is intended to assess the pharmacokinetics (PK), proprotein convertase subtilisin/kexin type 9 (PCSK9) reduction, safety and tolerability of AZD8233 in male and female participants with severe renal impairment and participants with ESRD compared to matched healthy control participants. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- AZD8233
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 sitePoland
- Study dates
- 10 Aug 2022to 23 Nov 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For Cohort 1 and 3 (CKD/ESRD): Participants that are on statins, ACEi/ARB, beta-blocker, diuretic or on any other cardio-renal relevant treatment, the dose should be stable at least 4 weeks prior to Screening (Visit 1) (no dose adjustments within 4 weeks prior to Screening [Visit 1]).
- For Cohort 2 (HV): Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring. (a) Have an eGFR of ≥ 90 mL/min/1.73 m^2 as determined at Screening (Visit 1) via the CKD-EPI formula.
- For Cohort 1 (CKD): Participants who are severely renally impaired.
- Have an eGFR of ≥15 to < 30 mL/min/1.73 m^2 as determined at Screening (Visit 1) via the CKD-EPI formula.
- For Cohort 3 (ESRD): Participants with ESRD on dialysis.
- Have an eGFR of < 15 mL/min/1.73 m^2.
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- Have been on stable intermittent haemodialysis for at least 3 months prior to Screening (Visit 1).
- Body weight of at least 50 kg and BMI within the range ≥ 18 to ≤ 35 kg/m^2 (inclusive).
- Female of non-childbearing potential or male. Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Who cannot join
- Participant has a positive SARS-CoV-2 test result within 2 weeks before screening (Visit 1) or between screening and admission to study centre (Day -22 to Day - 2).
- Clinical signs and symptoms consistent with COVID-19 (eg, fever, dry cough, dyspnoea, sore throat, fatigue) 2 weeks before screening (Visit 1) or between screening and admission to study centre (Visit 2).
- Participant has been previously hospitalised with COVID-19 infection within the last 3 months prior to Screening (Visit 1).
- Known or suspected history of substance dependence or a positive screen for drugs or alcohol abuse at the Screening Visit.
- Any laboratory values with the following deviations at the Screening Visit (Visit 1); test may be repeated at the discretion of the Investigator if abnormal:
- Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, and HIV. (b) Alanine aminotransferase > 1.5 × ULN (c) Aspartate aminotransferase > 1.5 × ULN (d) Total bilirubin > ULN (e) Haemoglobin < 9 g/dL (f) Platelet count ≤ LLN
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- Previous allogeneic bone marrow transplant.
- Non-leukocyte depleted whole blood transfusion within 120 days of genetic sample collection.
- 9. Participants with a known hypersensitivity to AZD8233 or any of the excipients of the product.
- 10. For Cohort 2: Any clinically significant disease or disorder (eg, cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal including bone fractures, endocrine including adrenal insufficiency, metabolic, malignant, psychiatric, major physical impairment,), skin disorder, history of, or ongoing clinically significant allergy/hypersensitivity.
- 11. Cohort 1 \& 3: Presence of unstable medical (e.g., diabetes) or psychological conditions and renal transplant patients.
- 12. Previous administration of AZD8233/AZD6615 or inclisiran (LEQVIO®, Novartis).
- 13. Current or previous treatment with drugs for reduction of PCSK9 (for example evolocumab, alirocumab or inclisiran).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Dose, Non-randomised, Open-label, Parallel Group Study to Assess the Pharmacokinetics, PCSK9 Reduction, Safety, and Tolerability of AZD8233 in Participants With Severe Renal Impairment, End Stage Renal Disease and Healthy Participants as Controls
The study is intended to assess the pharmacokinetics (PK), proprotein convertase subtilisin/kexin type 9 (PCSK9) reduction, safety and tolerability of AZD8233 in male and female participants with severe renal impairment and participants with ESRD compared to matched healthy control participants.
Read the detailed description
This is an open-label, single dose, non-randomised, parallel group study. Participant will be enrolled in 3 cohorts.
- Cohort 1 will include 8 participants with severe renal impairment (estimated glomerular filtration rate [eGFR] of ≥15 to < 30 mL/min/1.73 m^2).
- Cohort 2 will include 8 healthy participants with normal renal function (eGFR of ≥ 90 mL/min/1.73 m^2) that will serve as matched controls for Cohort 1 and Cohort 3. Matching will account for age, Body mass index (BMI), and gender.
- Cohort 3 will include 8 participants with ESRD on dialysis (eGFR of < 15 mL/min/1.73 m^2).
- Participants in Cohort 3 will receive a single dose of AZD8233 the day after haemodialysis.
Participant will receive the study drug on Day 1, discharged on Day 2 followed by out-patient follow-up visits on Day 3, 7, 14, 28, 42, 56, and 90.
- Conditions
- End Stage Renal Disease
- Being tested
- AZD8233
- Keywords
- End Stage Renal Disease (ESRD), Renal Impairment, Pharmacokinetic, Pharmacodynamic
- Medical subject headings
- Kidney Failure, Chronic, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD8233Drug
Participants will receive a single subcutaneous (SC) dose of AZD8233 into the region of the abdomen.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Participants with severe renal impairment will receive a single dose of AZD8233 on Day 1. Receives: Drug: AZD8233 |
| Cohort 2 | Experimental | Participants who are healthy will receive a single dose of AZD8233 on Day 1. Receives: Drug: AZD8233 |
| Cohort 3 | Experimental | Participants with ESRD on dialysis will receive a single dose of AZD8233 on Day 1. Receives: Drug: AZD8233 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observed maximum plasma concentration (Cmax)
The pharmacokinetics (PK) parameter of AZD8233 full-length antisense oligonucleotide (ASOs) in participants with severe renal impairment and ESRD compared to matched healthy control participants will be assessed using plasma concentrations. Cmax is defined as observed maximum plasma concentration of AZD8233.
Measured: Baseline, 24 hour post-dose, Day 3, 7, 14, 28, 42, 56 and 90
Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUCinf)
The PK of AZD8233 full-length ASOs in participants with severe renal impairment and ESRD compared to matched healthy control participants will be assessed using plasma concentrations. AUCinf is defined as area under the plasma concentration-time curve from time zero extrapolated to infinity of AZD8233. AUCinf is estimated by AUClast + Clast/λz where Clast is the observed last quantifiable drug concentration.
Measured: Baseline, 24 hour post-dose, Day 3, 7, 14, 28, 42, 56 and 90
Area under the plasma concentration-curve from time zero to time of last quantifiable concentration (AUClast)
The PK of AZD8233 full-length ASOs in participants with severe renal impairment and ESRD compared to matched healthy control participants will be assessed using plasma concentrations. AUClast is defined as area under the plasma concentration-curve from time zero to time of last quantifiable concentration of AZD8233.
Measured: Baseline, 24 hour post-dose, Day 3, 7, 14, 28, 42, 56 and 90
Area under the concentration-time curve from time zero to 24 hours after dosing (AUC0-24)
The PK of AZD8233 full-length ASOs in participants with severe renal impairment and ESRD compared to matched healthy control participants will be assessed using plasma concentrations. AUC0-24 is defined as area under the concentration-time curve from time zero to 24 hours after dosing of AZD8233.
Measured: Baseline, 24 hour post-dose
Renal clearance (CLR)
The PK of AZD8233 full-length ASOs in participants with severe renal impairment and ESRD compared to matched healthy control participants will be assessed using urine concentrations. CLR is defined as renal clearance of AZD8233 from plasma.
Measured: Post-dose (0-8 hour and 8-24 hour) at Day 1
Amount excreted in urine (Ae)
The PK of AZD8233 full-length ASOs in participants with severe renal impairment and ESRD compared to matched healthy control participants will be assessed using urine concentrations. The PK urine parameters for AZD8233 full-length ASOs will be derived from Ae. Ae(0-last) is defined as cumulative amount of analyte excreted unchanged in urine at the last sampling interval of AZD8233.
Measured: Post-dose (0-8 hour and 8-24 hour) at Day 1
Fraction unbound in plasma (fe)
The PK of AZD8233 full-length ASOs in participants with severe renal impairment and ESRD compared to matched healthy control participants will be assessed using urine concentrations. The PK urine parameters for AZD8233 full-length ASOs will be derived from fe. fe(0-last) is defined as percentage of dose excreted unchanged in urine from time zero to the last measured time-point for an analyte of AZD8233.
Measured: Post-dose (0-8 hour and 8-24 hour) at Day 1
Number of participants with adverse events (AEs)
To assess safety and tolerability of AZD8233 in participants with severe renal impairment, ESRD and their healthy matched controls.
Measured: Day 1 to Day 90
Secondary outcomes (1)
Percentage reduction in proprotein convertase subtilisin/kexin type 9 (PCSK9) plasma levels from baseline
To asses the percentage change from baseline in PCSK9 plasma levels over-time in participants with severe renal impairment and ESRD compared to their healthy matched controls.
Measured: Baseline, 24 hour post-dose, Day 3, 7, 14, 28, 42, 56 and 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2021
- Study start10 Aug 2022
- Primary completion23 Nov 2022
- Study completion23 Nov 2022
Why it stopped: A decision has been taken to discontinue the development of AZD8233 (PCSK9-ASO for sc administration) due to low likelihood of demonstrating a benefit significantly above the current standard of care for patients with high-risk hypercholesterolemia.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05065463
- Sponsor's protocol ID
- D7990C00007
- Other IDs
- 2021-003044-24
- Status last verified
- Dec 2022
- First submitted
- 23 Sep 2021
- Last updated
- 22 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the requests portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Dose, Non-randomised, Open-label, Parallel Group Study to Assess the Pharmacokinetics, PCSK9 Reduction, Safety, and Tolerability of AZD8233 in Participants With Severe Renal Impairment, End Stage Renal Disease and Healthy Participants as Controls
- ClinicalTrials.gov ID
- NCT05065463
- Acronym / sponsor ID
- D7990C00007
- Conditions
- End Stage Renal Disease
- Keywords
- End Stage Renal Disease (ESRD), Renal Impairment, Pharmacokinetic, Pharmacodynamic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: A decision has been taken to discontinue the development of AZD8233 (PCSK9-ASO for sc administration) due to low likelihood of demonstrating a benefit significantly above the current standard of care for patients with high-risk hypercholesterolemia.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 10 Aug 2022 (actual)
- Primary completion
- 23 Nov 2022 (actual)
- Study completion
- 23 Nov 2022 (actual)
- First posted
- 4 Oct 2021 (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.
The study is intended to assess the pharmacokinetics (PK), proprotein convertase subtilisin/kexin type 9 (PCSK9) reduction, safety and tolerability of AZD8233 in male and female participants with severe renal impairment and participants with ESRD compared to matched healthy control participants.
Detailed description
This is an open-label, single dose, non-randomised, parallel group study. Participant will be enrolled in 3 cohorts.
- Cohort 1 will include 8 participants with severe renal impairment (estimated glomerular filtration rate [eGFR] of ≥15 to < 30 mL/min/1.73 m^2).
- Cohort 2 will include 8 healthy participants with normal renal function (eGFR of ≥ 90 mL/min/1.73 m^2) that will serve as matched controls for Cohort 1 and Cohort 3. Matching will account for age, Body mass index (BMI), and gender.
- Cohort 3 will include 8 participants with ESRD on dialysis (eGFR of < 15 mL/min/1.73 m^2).
- Participants in Cohort 3 will receive a single dose of AZD8233 the day after haemodialysis.
Participant will receive the study drug on Day 1, discharged on Day 2 followed by out-patient follow-up visits on Day 3, 7, 14, 28, 42, 56, and 90.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: AZD8233Participants with severe renal impairment will receive a single dose of AZD8233 on Day 1. |
| Cohort 2 | Experimental | Drug: AZD8233Participants who are healthy will receive a single dose of AZD8233 on Day 1. |
| Cohort 3 | Experimental | Drug: AZD8233Participants with ESRD on dialysis will receive a single dose of AZD8233 on Day 1. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- For Cohort 1 and 3 (CKD/ESRD): Participants that are on statins, ACEi/ARB, beta-blocker, diuretic or on any other cardio-renal relevant treatment, the dose should be stable at least 4 weeks prior to Screening (Visit 1) (no dose adjustments within 4 weeks prior to Screening [Visit 1]).
- For Cohort 2 (HV): Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring. (a) Have an eGFR of ≥ 90 mL/min/1.73 m^2 as determined at Screening (Visit 1) via the CKD-EPI formula.
- For Cohort 1 (CKD): Participants who are severely renally impaired.
- For Cohort 3 (ESRD): Participants with ESRD on dialysis.
- Body weight of at least 50 kg and BMI within the range ≥ 18 to ≤ 35 kg/m^2 (inclusive).
Key exclusion criteria (13 listed)
- Participant has a positive SARS-CoV-2 test result within 2 weeks before screening (Visit 1) or between screening and admission to study centre (Day -22 to Day - 2).
- Clinical signs and symptoms consistent with COVID-19 (eg, fever, dry cough, dyspnoea, sore throat, fatigue) 2 weeks before screening (Visit 1) or between screening and admission to study centre (Visit 2).
- Participant has been previously hospitalised with COVID-19 infection within the last 3 months prior to Screening (Visit 1).
- Known or suspected history of substance dependence or a positive screen for drugs or alcohol abuse at the Screening Visit.
- Any laboratory values with the following deviations at the Screening Visit (Visit 1); test may be repeated at the discretion of the Investigator if abnormal:
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 |
|---|---|---|
| AZD8233Participants will receive a single subcutaneous (SC) dose of AZD8233 into the region of the abdomen. | Drug | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
Observed maximum plasma concentration (Cmax)
Time frame: Baseline, 24 hour post-dose, Day 3, 7, 14, 28, 42, 56 and 90
The pharmacokinetics (PK) parameter of AZD8233 full-length antisense oligonucleotide (ASOs) in participants with severe renal impairment and ESRD compared to matched healthy control participants will be assessed using plasma concentrations. Cmax is defined as observed maximum plasma concentration of AZD8233.
Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUCinf)
Time frame: Baseline, 24 hour post-dose, Day 3, 7, 14, 28, 42, 56 and 90
The PK of AZD8233 full-length ASOs in participants with severe renal impairment and ESRD compared to matched healthy control participants will be assessed using plasma concentrations. AUCinf is defined as area under the plasma concentration-time curve from time zero extrapolated to infinity of AZD8233. AUCinf is estimated by AUClast + Clast/λz where Clast is the observed last quantifiable drug concentration.
Area under the plasma concentration-curve from time zero to time of last quantifiable concentration (AUClast)
Time frame: Baseline, 24 hour post-dose, Day 3, 7, 14, 28, 42, 56 and 90
The PK of AZD8233 full-length ASOs in participants with severe renal impairment and ESRD compared to matched healthy control participants will be assessed using plasma concentrations. AUClast is defined as area under the plasma concentration-curve from time zero to time of last quantifiable concentration of AZD8233.
Area under the concentration-time curve from time zero to 24 hours after dosing (AUC0-24)
Time frame: Baseline, 24 hour post-dose
The PK of AZD8233 full-length ASOs in participants with severe renal impairment and ESRD compared to matched healthy control participants will be assessed using plasma concentrations. AUC0-24 is defined as area under the concentration-time curve from time zero to 24 hours after dosing of AZD8233.
Renal clearance (CLR)
Time frame: Post-dose (0-8 hour and 8-24 hour) at Day 1
The PK of AZD8233 full-length ASOs in participants with severe renal impairment and ESRD compared to matched healthy control participants will be assessed using urine concentrations. CLR is defined as renal clearance of AZD8233 from plasma.
Amount excreted in urine (Ae)
Time frame: Post-dose (0-8 hour and 8-24 hour) at Day 1
The PK of AZD8233 full-length ASOs in participants with severe renal impairment and ESRD compared to matched healthy control participants will be assessed using urine concentrations. The PK urine parameters for AZD8233 full-length ASOs will be derived from Ae. Ae(0-last) is defined as cumulative amount of analyte excreted unchanged in urine at the last sampling interval of AZD8233.
Fraction unbound in plasma (fe)
Time frame: Post-dose (0-8 hour and 8-24 hour) at Day 1
The PK of AZD8233 full-length ASOs in participants with severe renal impairment and ESRD compared to matched healthy control participants will be assessed using urine concentrations. The PK urine parameters for AZD8233 full-length ASOs will be derived from fe. fe(0-last) is defined as percentage of dose excreted unchanged in urine from time zero to the last measured time-point for an analyte of AZD8233.
Number of participants with adverse events (AEs)
Time frame: Day 1 to Day 90
To assess safety and tolerability of AZD8233 in participants with severe renal impairment, ESRD and their healthy matched controls.
1 secondary outcome
Percentage reduction in proprotein convertase subtilisin/kexin type 9 (PCSK9) plasma levels from baseline
Time frame: Baseline, 24 hour post-dose, Day 3, 7, 14, 28, 42, 56 and 90
Results and safety
The study was stopped early (reason given: A decision has been taken to discontinue the development of AZD8233 (PCSK9-ASO for sc administration) due to low likelihood of demonstrating a benefit significantly above the current standard of care for patients with high-risk hypercholesterolemia.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2022.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the requests portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD8233 in people with End Stage Renal Disease, run by AstraZeneca at 1 site in Poland.
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 9 inclusion and 13 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: stopped early, as of the sponsor's last update on 22 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. 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 was stopped early (reason given: A decision has been taken to discontinue the development of AZD8233 (PCSK9-ASO for sc administration) due to low likelihood of demonstrating a benefit significantly above the current standard of care for patients with high-risk hypercholesterolemia.). Results are not available in the source record.
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?
Observed maximum plasma concentration (Cmax) (time frame: Baseline, 24 hour post-dose, Day 3, 7, 14, 28, 42, 56 and 90). The study lists 8 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 22 Dec 2022.