Kidney FailurePhase 1NCT07754331
Study of the Effect of Haemodialysis on the Pharmacokinetics, Safety, and Tolerability of Balcinrenone/Dapagliflozin
A Phase 1 study testing Balcinrenone/dapagliflozin in people with Kidney Failure, run by AstraZeneca at 1 site in United States.
Trial summary
The purpose of this study is to investigate the effect of HD on single oral dose PK, safety, and tolerability of balcinrenone/dapagliflozin to male and female participants with kidney failure on intermittent HD. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Kidney Failure
- What is being tested?
- Balcinrenone/dapagliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Aug 2026to 6 Oct 2026
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant must have kidney failure and must have been on stable intermittent HD for at least 3 months prior to screening.
- Participant must be stable on a concomitant medication and/or treatment regimen (defined as not starting a new treatment/medication[s] or a change in the dosage or frequency of the concomitant medication[s] within at least 4 weeks prior to screening).
- Participants with controlled T2DM may be included, if they have: (a) HbA1c ≤ 10% at screening.
- Body weight ≥ 50 kg and BMI within the range 18 to 40 kg/m2, inclusive, as measured at screening.
- All female participants must have a negative serum pregnancy test at screening and all females of child-bearing potential must have a negative serum pregnancy test on Periods 1 and 2 Day -1 and must not be lactating (confirmed at screening). Females must also fulfil one of the following criteria: Females not of child-bearing potential, defined as females who are either permanently sterilised (hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation) or who are post-menopausal; OR Females of child-bearing potential who are sexually active with a nonsterilised male must use one highly effective method of birth control from enrolment throughout the study and until at least 4 weeks after the last dose of study intervention
- Capable of giving signed informed consent
- Provision of signed and dated written Optional Genomics Initiative Research Information and Consent Form prior to collection of samples for optional genomics initiative research that supports the Genomic Initiative
Who cannot join
- Presence of any uncontrolled or clinically significant disease or disorder (other than renal disease and conditions related to the renal disease, such as stable T2DM and stable hypertension), or any medical or surgical condition that, in the opinion of the investigator, may either interfere with participation in the clinical study and/or put the participant at significant risk (according to the investigator's judgement) if he/she participates in the clinical study.
- Any clinically significant illness, medical/major surgical procedure, or trauma within 4 weeks prior to the first study intervention
- Severe hepatic impairment (CP Class C).
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to balcinrenone and dapagliflozin
- Abnormal resting vital signs at screening or Period 1 Day -1 (after resting for at least 5 minutes) of: (a) supine BP: (i) > 180 mmHg or < 90 mmHg systolic. (ii) > 95 mmHg or < 40 mmHg diastolic.
- Successful renal transplant patients, participants waiting for organ transplant scheduled to occur during the study, and those with a history of acute kidney injury occurring within 3 months prior to screening. Nonfunctioning renal allografts are allowed
Show all 21Show fewer
- Any clinically significant abnormalities on 12-lead ECG at the screening, as judged by the investigator
- Positive test for human immunodeficiency virus at screening.
- Positive results at screening for hepatitis B surface antigen or hepatitis C antibody.
- Known history of drug or alcohol abuse within 1 year of screening and/or consumes > 14 units per week for males and > 7 units per week for females. One unit of alcohol equals 12 oz (360 mL) beer, 1½ oz (45 mL) liquor, or 5 oz (150 mL) wine
- The following medications are prohibited within 4 weeks prior to the first study intervention until follow-up: (a) MR antagonists; (b) SGLT2 inhibitors
- The following medications are prohibited within 1 week prior to the first study intervention until follow-up: Strong or moderate inducers or inhibitors of CYP3A4
- Has received another new chemical entity (defined as a compound which has not been approved for marketing) within 30 days prior to study intervention in this study or, if known, 5 half-lives from last dose in the previous study to study intervention in this study, whichever is longest
- Previous enrolment in the present study.
- Positive screen for drugs of abuse including cannabis/marijuana and/or alcohol test at screening or Period 1 Day -1.
- Receipt of blood products within 2 months prior to Period 1 Day -1, plasma or platelets donation within 1 month prior to Period 1 Day -1, or any blood donation/blood loss > 500 mL within 3 months prior to Period 1 Day -1.
- History of smoking more than 10 cigarettes (or equivalent amount of tobacco) per day within 3 months prior to Period 1 Day -1.
- Excessive intake of caffeine-containing drinks or food (eg, coffee, tea, chocolate) as judged by the investigator
- Involvement of any AstraZeneca or clinical unit employee or their close relatives.
- Vulnerable participants, eg, kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order.
- Judgement by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements. Inability to eat at least 80% of the breakfast meal on Periods 1 and 2 Day 1 is exclusionary.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Single-Centre, Randomised, Single-dose, Open-label, 2-period, 2-way Crossover Study to Assess the Effect of Haemodialysis on the Pharmacokinetics, Safety, and Tolerability of Balcinrenone/Dapagliflozin in Participants With Kidney Failure
The purpose of this study is to investigate the effect of HD on single oral dose PK, safety, and tolerability of balcinrenone/dapagliflozin to male and female participants with kidney failure on intermittent HD.
- Conditions
- Kidney Failure
- Being tested
- Balcinrenone/dapagliflozin
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balcinrenone/dapagliflozinDrug
Participants will be receiving balcinrenone/ dapagliflozin before or after hemodialysis
| Study group | Role | What they receive |
|---|---|---|
| Sequence AB | Other | Participants will receive Treatment A (balcinrenone/dapagliflozin capsule administered 1,5 hours before the start of a 4-hour hemodialysis session) on Day 1. After a wash-out period of ≥ 7 days, participants will receive Treatment B (balcinrenone/dapagliflozin capsule administered 1 hour after the completion of a 4-hour hemodialysis session) Receives: Drug: Balcinrenone/dapagliflozin |
| Sequence BA | Other | Participants will receive Treatment B (balcinrenone/dapagliflozin capsule administered 1 hour after the completionof a 4-hour hemodialysis session) on Day 1. After a wash-out period of ≥ 7 days, participants will receive Treatment A (balcinrenone/dapagliflozin capsule administered 1.5 hours before the start of a 4-hour hemodialysis session) Receives: Drug: Balcinrenone/dapagliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK parameters AUCinf
To evaluate the effect of HD on the PK of balcinrenone/dapagliflozin
Measured: Day 1 to 3 for each treatment period (each treatment period is 4 days)
PK Parameters AUClast
To evaluate the effect of HD on the PK of balcinrenone/dapagliflozin
Measured: Day 1 to 3 for each treatment period (each treatment period is 4 days)
PK Parameters Cmax
To evaluate the effect of HD on the PK of balcinrenone/dapagliflozin
Measured: Day 1 to 3 for each treatment period (each treatment period is 4 days)
PK parameters C24 from plasma
To evaluate the PK of balcinrenone/dapagliflozin in plasma in participants with kidney failure on HD
Measured: Day 1 to 3 for each treatment period (each treatment period is 4 days)
PK parameters tmax from plasma
To evaluate the PK of balcinrenone/dapagliflozin in plasma in participants with kidney failure on HD
Measured: Day 1 to 3 for each treatment period (each treatment period is 4 days)
PK parameters t1/2λz from plasma
To evaluate the PK of balcinrenone/dapagliflozin in plasma in participants with kidney failure on HD
Measured: Day 1 to 3 for each treatment period (each treatment period is 4 days)
PK parameters CLNR (balcinrenone only) from plasma
To evaluate the PK of balcinrenone/dapagliflozin in plasma in participants with kidney failure on HD
Measured: Day 1 to 3 for each treatment period (each treatment period is 4 days)
PK parameters CL/F from plasma
To evaluate the PK of balcinrenone/dapagliflozin in plasma in participants with kidney failure on HD
Measured: Day 1 to 3 for each treatment period (each treatment period is 4 days)
PK parameters AUC(t1-t2)_out from plasma
To evaluate the PK of balcinrenone/dapagliflozin in plasma in participants with kidney failure on HD
Measured: Day 1 to 3 for each treatment period (each treatment period is 4 days)
PK parameters CLD from dialysate
To evaluate the PK of balcinrenone/dapagliflozin in dialysate in participants with kidney failure on HD
Measured: Day 1 to 3 for each treatment period (each treatment period is 4 days)
PK parameters AeD from dialysate
To evaluate the PK of balcinrenone/dapagliflozin in dialysate in participants with kidney failure on HD
Measured: Day 1 to 3 for each treatment period (each treatment period is 4 days)
PK parameters feD from dialysate
To evaluate the PK of balcinrenone/dapagliflozin in dialysate in participants with kidney failure on HD
Measured: Day 1 to 3 for each treatment period (each treatment period is 4 days)
PK parameters Vz/F from plasma
To evaluate the PK of balcinrenone/dapagliflozin in plasma in participants with kidney failure on HD
Measured: Day 1 to 3 for each treatment period (each treatment period is 4 days)
PK parameters AUC(t1-t2) from plasma
To evaluate the PK of balcinrenone/dapagliflozin in plasma in participants with kidney failure on HD
Measured: Day 1 to 3 for each treatment period (each treatment period is 4 days)
Secondary outcomes (2)
AEs
To assess the safety and tolerability of single doses of balcinrenone/dapagliflozin in participants with kidney failure on HD
Measured: from Period 1, Day 1 until follow-up on Day 9-11 post-dose Period 2.
SAEs
To assess the safety and tolerability of single doses of balcinrenone/dapagliflozin in participants with kidney failure on HD
Measured: from screening until follow-up on Day 9-11 post-dose Period 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start6 Aug 2026
- Primary completion6 Oct 2026
- Study completion6 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney FailureStudies 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
- Randomised
- Intervention model
- Crossover
- Model description
- There will be two treatment periods performed in a crossover fashion in order to evaluate the PK of 40 mg/10 mg balcinrenone/dapagliflozin with dosing before and after HD, with a 7-day washout period between the two treatments.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fortrea
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07754331
- Sponsor's protocol ID
- D8790C00002
- Other IDs
- 149932
- Status last verified
- Oct 2026
- First submitted
- 13 Jul 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single-Centre, Randomised, Single-dose, Open-label, 2-period, 2-way Crossover Study to Assess the Effect of Haemodialysis on the Pharmacokinetics, Safety, and Tolerability of Balcinrenone/Dapagliflozin in Participants With Kidney Failure
- ClinicalTrials.gov ID
- NCT07754331
- Acronym / sponsor ID
- D8790C00002
- Conditions
- Kidney Failure
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Fortrea
- Study start
- 6 Aug 2026 (actual)
- Primary completion
- 6 Oct 2026 (actual)
- Study completion
- 6 Oct 2026 (actual)
- First posted
- 10 Aug 2026 (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 purpose of this study is to investigate the effect of HD on single oral dose PK, safety, and tolerability of balcinrenone/dapagliflozin to male and female participants with kidney failure on intermittent HD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- There will be two treatment periods performed in a crossover fashion in order to evaluate the PK of 40 mg/10 mg balcinrenone/dapagliflozin with dosing before and after HD, with a 7-day washout period between the two treatments.
| Arm | Type | Receives |
|---|---|---|
| Sequence AB | Other | Drug: Balcinrenone/dapagliflozinParticipants will receive Treatment A (balcinrenone/dapagliflozin capsule administered 1,5 hours before the start of a 4-hour hemodialysis session) on Day 1. After a wash-out period of ≥ 7 days, participants will receive Treatment B (balcinrenone/dapagliflozin capsule administered 1 hour after the completion of a 4-hour hemodialysis session) |
| Sequence BA | Other | Drug: Balcinrenone/dapagliflozinParticipants will receive Treatment B (balcinrenone/dapagliflozin capsule administered 1 hour after the completionof a 4-hour hemodialysis session) on Day 1. After a wash-out period of ≥ 7 days, participants will receive Treatment A (balcinrenone/dapagliflozin capsule administered 1.5 hours before the start of a 4-hour hemodialysis session) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participant must have kidney failure and must have been on stable intermittent HD for at least 3 months prior to screening.
- Participant must be stable on a concomitant medication and/or treatment regimen (defined as not starting a new treatment/medication[s] or a change in the dosage or frequency of the concomitant medication[s] within at least 4 weeks prior to screening).
- Participants with controlled T2DM may be included, if they have: (a) HbA1c ≤ 10% at screening.
- Body weight ≥ 50 kg and BMI within the range 18 to 40 kg/m2, inclusive, as measured at screening.
- All female participants must have a negative serum pregnancy test at screening and all females of child-bearing potential must have a negative serum pregnancy test on Periods 1 and 2 Day -1 and must not be lactating (confirmed at screening). Females must also fulfil one of the following criteria: Females not of child-bearing potential, defined as females who are either permanently sterilised (hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation) or who are post-menopausal; OR Females of child-bearing potential who are sexually active with a nonsterilised male must use one highly effective method of birth control from enrolment throughout the study and until at least 4 weeks after the last dose of study intervention
Key exclusion criteria (21 listed)
- Presence of any uncontrolled or clinically significant disease or disorder (other than renal disease and conditions related to the renal disease, such as stable T2DM and stable hypertension), or any medical or surgical condition that, in the opinion of the investigator, may either interfere with participation in the clinical study and/or put the participant at significant risk (according to the investigator's judgement) if he/she participates in the clinical study.
- Any clinically significant illness, medical/major surgical procedure, or trauma within 4 weeks prior to the first study intervention
- Severe hepatic impairment (CP Class C).
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to balcinrenone and dapagliflozin
- Abnormal resting vital signs at screening or Period 1 Day -1 (after resting for at least 5 minutes) of: (a) supine BP: (i) > 180 mmHg or < 90 mmHg systolic. (ii) > 95 mmHg or < 40 mmHg diastolic.
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 |
|---|---|---|
| Balcinrenone/dapagliflozinParticipants will be receiving balcinrenone/ dapagliflozin before or after hemodialysis | Drug | Sequence AB, Sequence BA |
Primary outcome
PK parameters AUCinf
Time frame: Day 1 to 3 for each treatment period (each treatment period is 4 days)
To evaluate the effect of HD on the PK of balcinrenone/dapagliflozin
PK Parameters AUClast
Time frame: Day 1 to 3 for each treatment period (each treatment period is 4 days)
To evaluate the effect of HD on the PK of balcinrenone/dapagliflozin
PK Parameters Cmax
Time frame: Day 1 to 3 for each treatment period (each treatment period is 4 days)
To evaluate the effect of HD on the PK of balcinrenone/dapagliflozin
PK parameters C24 from plasma
Time frame: Day 1 to 3 for each treatment period (each treatment period is 4 days)
To evaluate the PK of balcinrenone/dapagliflozin in plasma in participants with kidney failure on HD
PK parameters tmax from plasma
Time frame: Day 1 to 3 for each treatment period (each treatment period is 4 days)
To evaluate the PK of balcinrenone/dapagliflozin in plasma in participants with kidney failure on HD
PK parameters t1/2λz from plasma
Time frame: Day 1 to 3 for each treatment period (each treatment period is 4 days)
To evaluate the PK of balcinrenone/dapagliflozin in plasma in participants with kidney failure on HD
PK parameters CLNR (balcinrenone only) from plasma
Time frame: Day 1 to 3 for each treatment period (each treatment period is 4 days)
To evaluate the PK of balcinrenone/dapagliflozin in plasma in participants with kidney failure on HD
PK parameters CL/F from plasma
Time frame: Day 1 to 3 for each treatment period (each treatment period is 4 days)
To evaluate the PK of balcinrenone/dapagliflozin in plasma in participants with kidney failure on HD
PK parameters AUC(t1-t2)_out from plasma
Time frame: Day 1 to 3 for each treatment period (each treatment period is 4 days)
To evaluate the PK of balcinrenone/dapagliflozin in plasma in participants with kidney failure on HD
PK parameters CLD from dialysate
Time frame: Day 1 to 3 for each treatment period (each treatment period is 4 days)
To evaluate the PK of balcinrenone/dapagliflozin in dialysate in participants with kidney failure on HD
PK parameters AeD from dialysate
Time frame: Day 1 to 3 for each treatment period (each treatment period is 4 days)
To evaluate the PK of balcinrenone/dapagliflozin in dialysate in participants with kidney failure on HD
PK parameters feD from dialysate
Time frame: Day 1 to 3 for each treatment period (each treatment period is 4 days)
To evaluate the PK of balcinrenone/dapagliflozin in dialysate in participants with kidney failure on HD
PK parameters Vz/F from plasma
Time frame: Day 1 to 3 for each treatment period (each treatment period is 4 days)
To evaluate the PK of balcinrenone/dapagliflozin in plasma in participants with kidney failure on HD
PK parameters AUC(t1-t2) from plasma
Time frame: Day 1 to 3 for each treatment period (each treatment period is 4 days)
To evaluate the PK of balcinrenone/dapagliflozin in plasma in participants with kidney failure on HD
2 secondary outcomes
AEs
Time frame: from Period 1, Day 1 until follow-up on Day 9-11 post-dose Period 2.
SAEs
Time frame: from screening until follow-up on Day 9-11 post-dose Period 2
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 20 Oct 2026.
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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 Balcinrenone/dapagliflozin in people with Kidney Failure, run by AstraZeneca at 1 site 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 7 inclusion and 21 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 20 Oct 2026. 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 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?
PK parameters AUCinf (time frame: Day 1 to 3 for each treatment period (each treatment period is 4 days)). The study lists 14 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 20 Oct 2026.