Renal ImpairmentPhase 1NCT06742762
A Phase I Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD5004
A Phase 1 study testing AZD5004 in people with Renal Impairment, run by AstraZeneca at 3 sites in United States.
Trial summary
This is a Phase I, multicentre, single-dose, non-randomised, open-label, parallel-group study to examine the PK, safety, and tolerability of AZD5004 in male and female participants with severe renal impairment and moderate renal impairment (optional) compared with male and female participants with normal renal… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Impairment
- What is being tested?
- AZD5004
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 3 sitesUnited States
- Study dates
- 17 Dec 2024to 20 Apr 2025
- 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
- Adults 18-80 years of age
- Weight >50kg and BMI between 18-40 kg/m2
- For participants with normal renal function:
- -Participant must be medically healthy with no significant findings on medical evaluation and an eGFR ≥90 ml/min at screening.
- For participants with renal impairment:
- Group 1 (severe) must have an eGFR <30 ml/min and Group 3 (moderate) must have an eGFR 30 to <60 ml/min based on CKD-EPI calculations for at least 6 months prior to enrollment.
Who cannot join
- Poorly controlled diabetes mellitus (A1C >10% at screening or recent history of diabetic ketoacidosis or symptomatic hypoglycemia).
- Unwillingness to use adequate contraception
- Uncontrolled hypertension or hypotension.
- Positive screening for HIV, Hepatitis B, or Hepatitis C
- Presence of unstable systemic disease or psychologic conditions. Abnormal laboratory values to include but not limited to liver function tests (thresholds differ for renal impairment and health controls)
- Any change in baseline medication within 2 weeks of planned study initiation.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Research Site
Miami Lakes, Florida, 33014
Research Site
Orlando, Florida, 32808
Research Site
Orlando, Florida, 32809
About this study
Official title: A Phase I, Multicentre, Single-Dose, Non-Randomised, Open-Label, Parallel Group Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD5004
This is a Phase I, multicentre, single-dose, non-randomised, open-label, parallel-group study to examine the PK, safety, and tolerability of AZD5004 in male and female participants with severe renal impairment and moderate renal impairment (optional) compared with male and female participants with normal renal function.
Read the detailed description
This is a Phase I, multicentre, single-dose, non-randomised, open-label, parallel-group study to examine the PK, safety, and tolerability of AZD5004 in male and female participants with severe renal impairment and moderate renal impairment (optional) compared with male and female participants with normal renal function.
Participants will be assigned to the following groups based on eGFR determined at screening by a local laboratory using serum creatinine:
Group 1: Participants with severe renal impairment (eGFR < 30 mL/min), not on dialysis.
Group 2: Participants with normal renal function (eGFR of ≥ 90 mL/min) matched by sex, age, and body weight on a group level to the impaired participants.
Group 3 (optional): Participants with moderate renal impairment (eGFR ≥ 30 to < 60 mL/min).
- Conditions
- Renal Impairment
- Being tested
- AZD5004
- Keywords
- Renal Impairment, Healthy participants, AZD5004, Pharmacokinetics, Safety
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD5004Drug
Also called ECC5004, Dose 1
Dose 1
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Participants with severe renal impairment will receive a single oral dose of AZD5004 under fasted conditions. Receives: Drug: AZD5004 |
| Group 2 | Experimental | Participants with normal renal function will receive a single oral dose of AZD5004 under fasted conditions. Receives: Drug: AZD5004 |
| Group 3 (Optional) | Experimental | Participants with moderate renal impairment will receive a single oral dose of AZD5004 under fasted conditions. Receives: Drug: AZD5004 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCinf
Area under the concentration-time curve from zero to infinity
Measured: Day 1 to Day 5
AUClast
Area under the concentration-time curve from zero to the last measurable concentration
Measured: Day 1 to Day 5
Cmax
Maximum observed plasma concentration
Measured: Day 1 to Day 5
Secondary outcomes (8)
Tmax
Time to reach maximum observed plasma concentration
Measured: Day 1 to Day 5
PK parameter t1/2λz
Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve
Measured: Day 1 to Day 5
PK parameter CL/F
Apparent total body clearance of drug from plasma after extravascular administration
Measured: Day 1 to Day 5
PK parameter CLNR/F
non-renal clearance of drug from plasma after oral administration
Measured: Day 1 to Day 5
PK parameter Vz/F
Apparent volume of distribution during the terminal phase after extravascular administration
Measured: Day 1 to Day 5
PK parameter CLr
Renal clearance of the drug from plasma
Measured: Day 1 to Day 5
PK parameter Ae
Cumulative amount of unchanged drug excreted into the urine
Measured: Day 1 to Day 5
fe
Fraction of the drug excreted into the urine
Measured: Day 1 to Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start17 Dec 2024
- Primary completion20 Apr 2025
- Study completion20 Apr 2025
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.
- 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
- Model description
- Up to three groups (two renal impairment groups and controls with normal renal function) will be enrolled into this study. All subjects will receive the study intervention: Group 1 will enroll 7 participants with severe renal impairment Group 2 will enroll \~7 participants with normal renal function matched by sex, age, and body weight Group 3 (optional) will enroll 7 participants with moderate renal impairment
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06742762
- Sponsor's protocol ID
- D7260C00006
- Status last verified
- Jun 2025
- First submitted
- 16 Dec 2024
- Last updated
- 8 Jun 2025
- 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 request 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 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Multicentre, Single-Dose, Non-Randomised, Open-Label, Parallel Group Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD5004
- ClinicalTrials.gov ID
- NCT06742762
- Acronym / sponsor ID
- D7260C00006
- Conditions
- Renal Impairment
- Keywords
- Renal Impairment, Healthy participants, AZD5004, Pharmacokinetics, Safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 17 Dec 2024 (actual)
- Primary completion
- 20 Apr 2025 (actual)
- Study completion
- 20 Apr 2025 (actual)
- First posted
- 19 Dec 2024 (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 Phase I, multicentre, single-dose, non-randomised, open-label, parallel-group study to examine the PK, safety, and tolerability of AZD5004 in male and female participants with severe renal impairment and moderate renal impairment (optional) compared with male and female participants with normal renal function.
Detailed description
This is a Phase I, multicentre, single-dose, non-randomised, open-label, parallel-group study to examine the PK, safety, and tolerability of AZD5004 in male and female participants with severe renal impairment and moderate renal impairment (optional) compared with male and female participants with normal renal function.
Participants will be assigned to the following groups based on eGFR determined at screening by a local laboratory using serum creatinine:
Group 1: Participants with severe renal impairment (eGFR < 30 mL/min), not on dialysis.
Group 2: Participants with normal renal function (eGFR of ≥ 90 mL/min) matched by sex, age, and body weight on a group level to the impaired participants.
Group 3 (optional): Participants with moderate renal impairment (eGFR ≥ 30 to < 60 mL/min).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Up to three groups (two renal impairment groups and controls with normal renal function) will be enrolled into this study. All subjects will receive the study intervention: Group 1 will enroll 7 participants with severe renal impairment Group 2 will enroll ~7 participants with normal renal function matched by sex, age, and body weight Group 3 (optional) will enroll 7 participants with moderate renal impairment
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: AZD5004Participants with severe renal impairment will receive a single oral dose of AZD5004 under fasted conditions. |
| Group 2 | Experimental | Drug: AZD5004Participants with normal renal function will receive a single oral dose of AZD5004 under fasted conditions. |
| Group 3 (Optional) | Experimental | Drug: AZD5004Participants with moderate renal impairment will receive a single oral dose of AZD5004 under fasted conditions. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults 18-80 years of age
- Weight >50kg and BMI between 18-40 kg/m2
- -Participant must be medically healthy with no significant findings on medical evaluation and an eGFR ≥90 ml/min at screening.
- Group 1 (severe) must have an eGFR <30 ml/min and Group 3 (moderate) must have an eGFR 30 to <60 ml/min based on CKD-EPI calculations for at least 6 months prior to enrollment.
Key exclusion criteria (6 listed)
- Poorly controlled diabetes mellitus (A1C >10% at screening or recent history of diabetic ketoacidosis or symptomatic hypoglycemia).
- Unwillingness to use adequate contraception
- Uncontrolled hypertension or hypotension.
- Positive screening for HIV, Hepatitis B, or Hepatitis C
- Presence of unstable systemic disease or psychologic conditions. Abnormal laboratory values to include but not limited to liver function tests (thresholds differ for renal impairment and health controls)
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 |
|---|---|---|
| AZD5004Also: ECC5004, Dose 1Dose 1 | Drug | Group 1, Group 2, Group 3 (Optional) |
Primary outcome
AUCinf
Time frame: Day 1 to Day 5
Area under the concentration-time curve from zero to infinity
AUClast
Time frame: Day 1 to Day 5
Area under the concentration-time curve from zero to the last measurable concentration
Cmax
Time frame: Day 1 to Day 5
Maximum observed plasma concentration
8 secondary outcomes
Tmax
Time frame: Day 1 to Day 5
PK parameter t1/2λz
Time frame: Day 1 to Day 5
PK parameter CL/F
Time frame: Day 1 to Day 5
PK parameter CLNR/F
Time frame: Day 1 to Day 5
PK parameter Vz/F
Time frame: Day 1 to Day 5
PK parameter CLr
Time frame: Day 1 to Day 5
PK parameter Ae
Time frame: Day 1 to Day 5
fe
Time frame: Day 1 to Day 5
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 8 Jun 2025.
- 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 request 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD5004 in people with Renal Impairment, run by AstraZeneca at 3 sites in United States.
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 6 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 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
AUCinf (time frame: Day 1 to Day 5). The study lists 3 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 8 Jun 2025.