Renal ImpairmentPhase 1D2570-107NCT07715175
The Study is to Investigate D-2570 in Participants With Different Levels of Kidney Function.
A Phase 1 study testing D-2570 in people with Renal Impairment, run by InventisBio Co., Ltd at 1 site in China.
Trial summary
This study is divided two parts into: Part A and Part B. Part A will recruit 24 research participants, and Part B will recruit 16 research participants. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Impairment
- What is being tested?
- D-2570
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 8 Aug 2026to 21 Nov 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Voluntarily participate in this study after adequate informed consent, sign the written informed consent form, and agree to comply with all procedures specified in the study protocol;
- Aged 18 to 70 years (inclusive). Age matching will be conducted between the normal renal function group and the matched renal impairment group with a mean difference within ±10 years;
- Male and female participants are eligible. Gender matching will be performed between the normal renal function group and the matched renal impairment group with a difference of no more than 1 subject;
- Male participants weigh no less than 50 kg, and female participants weigh no less than 45 kg. Body mass index (BMI) = weight (kg) / height squared (m²), ranging from 19 to 30 kg/m² (inclusive). Weight matching will be conducted between the normal renal function group and the matched renal impairment group with a mean difference within ±10 kg;
Who cannot join
- Allergic constitution (e.g., allergy to pollen, two or more types of drugs/foods), or history of atopic diseases such as asthma and urticaria, or known hypersensitivity to the study drug or its excipients;
- Positive T-SPOT result at screening. Combined with clinical signs and chest posteroanterior X-ray findings, the participant is judged by the investigator to have active pulmonary tuberculosis;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022
Huan Zhou, Doctor, 13665527160, zhouhuanbest@vip.163.com
About this study
Official title: A Study to Evaluate the Pharmacokinetics of D-2570 in Participants With Renal Impairment Compared to Those With Normal Renal Function
This study is divided two parts into: Part A and Part B. Part A will recruit 24 research participants, and Part B will recruit 16 research participants.
Read the detailed description
Subjects of this study will be admitted to the Phase I ward of the research center one day before drug administration . On the first day, subjects will orally take a single dose of D-2570. The researchers will collect a series of blood and urine samples before and after drug D - 2570 administration to determine the drug concentration and evaluate the pharmacokinetic characteristics. The subjects can leave site after completing the safety evaluation.
- Conditions
- Renal Impairment
- Being tested
- D-2570
- Keywords
- Renal Impairment
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-2570Drug
receive a single dose of D-2570
| Study group | Role | What they receive |
|---|---|---|
| participants with normal renal function | Experimental | Subjects will receive a single dose of D-2570 Receives: Drug: D-2570 |
| participants with Mild Renal Impairment | Experimental | Subjects will receive a single dose of D-2570 (Part B) Receives: Drug: D-2570 |
| participants with Moderate Renal Impairment | Experimental | Subjects will receive a single dose of D-2570 (Part A) Receives: Drug: D-2570 |
| participants with Severe Renal Impairment | Experimental | Subjects will receive a single dose of D-2570 (Part A) Receives: Drug: D-2570 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The main PK parameters -Time to maximum measured plasma concentration -Tmax
The main PK parameters -Time to maximum measured plasma concentration -Tmax
Measured: Through study completion (approximately Day9)
Maximum observed plasma concentration-Cmax
Maximum observed plasma concentration-Cmax
Measured: Through study completion (approximately Day9)
The main PK parameters Half-life -t1/2
The main PK parameters Half-life -t1/2
Measured: Through study completion (approximately Day9)
The main PK parameters#Area under the plasma concentration versus time curve-AUC
The main PK parameters#Area under the plasma concentration versus time curve-AUC
Measured: Through study completion (approximately Day9)
The main PK parameters-CL/F (apparent clearance)
The main PK parameters-CL/F (apparent clearance)
Measured: Through study completion (approximately Day9)
The main PK parameters-Vz/F (apparent volume of distribution)
The main PK parameters-Vz/F (apparent volume of distribution)
Measured: Through study completion (approximately Day9)
The cumulative excretion amount (Aeu)
The cumulative excretion (Aeu) of D - 2570 and its metabolites in urine
Measured: Through study completion (approximately Day9)
The fraction of drug excreted in urine (Feu)
The fraction of drug excreted in urine (Feu) of D - 2570 and its metabolites in urine
Measured: Through study completion (approximately Day9)
The renal clearance rate (CLR)
The renal clearance rate (CLR)of D - 2570 and its metabolites in urine
Measured: Through study completion (approximately Day9)
Secondary outcomes (1)
Number of participants with treatment-related adverse events as assessed by CTCAE v6.0
Incidence of adverse events
Measured: Through study completion (approximately Day9)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start8 Aug 2026
- Primary completion21 Nov 2026 (estimated)
- Study completion21 Nov 2026 (estimated)
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 InventisBio Co., LtdThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InventisBio Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Huan Zhou, Doctor, Principal investigator, The First Affiliated Hospital of Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07715175
- Sponsor's protocol ID
- D2570-107
- Other IDs
- CTR20261754
- Acronym
- D2570-107
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Pharmacokinetics of D-2570 in Participants With Renal Impairment Compared to Those With Normal Renal Function
- ClinicalTrials.gov ID
- NCT07715175
- Acronym / sponsor ID
- D2570-107 / D2570-107
- Conditions
- Renal Impairment
- Keywords
- Renal Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- InventisBio Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 8 Aug 2026 (actual)
- Primary completion
- 21 Nov 2026 (estimated)
- Study completion
- 21 Nov 2026 (estimated)
- First posted
- 20 Jul 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.
This study is divided two parts into: Part A and Part B. Part A will recruit 24 research participants, and Part B will recruit 16 research participants.
Detailed description
Subjects of this study will be admitted to the Phase I ward of the research center one day before drug administration . On the first day, subjects will orally take a single dose of D-2570. The researchers will collect a series of blood and urine samples before and after drug D - 2570 administration to determine the drug concentration and evaluate the pharmacokinetic characteristics. The subjects can leave site after completing the safety evaluation.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| participants with normal renal function | Experimental | Drug: D-2570Subjects will receive a single dose of D-2570 |
| participants with Mild Renal Impairment | Experimental | Drug: D-2570Subjects will receive a single dose of D-2570 (Part B) |
| participants with Moderate Renal Impairment | Experimental | Drug: D-2570Subjects will receive a single dose of D-2570 (Part A) |
| participants with Severe Renal Impairment | Experimental | Drug: D-2570Subjects will receive a single dose of D-2570 (Part A) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Voluntarily participate in this study after adequate informed consent, sign the written informed consent form, and agree to comply with all procedures specified in the study protocol;
- Aged 18 to 70 years (inclusive). Age matching will be conducted between the normal renal function group and the matched renal impairment group with a mean difference within ±10 years;
- Male and female participants are eligible. Gender matching will be performed between the normal renal function group and the matched renal impairment group with a difference of no more than 1 subject;
- Male participants weigh no less than 50 kg, and female participants weigh no less than 45 kg. Body mass index (BMI) = weight (kg) / height squared (m²), ranging from 19 to 30 kg/m² (inclusive). Weight matching will be conducted between the normal renal function group and the matched renal impairment group with a mean difference within ±10 kg;
Key exclusion criteria (2 listed)
- Allergic constitution (e.g., allergy to pollen, two or more types of drugs/foods), or history of atopic diseases such as asthma and urticaria, or known hypersensitivity to the study drug or its excipients;
- Positive T-SPOT result at screening. Combined with clinical signs and chest posteroanterior X-ray findings, the participant is judged by the investigator to have active pulmonary tuberculosis;
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 |
|---|---|---|
| D-2570receive a single dose of D-2570 | Drug | participants with Mild Renal Impairment, participants with Moderate Renal Impairment, participants with Severe Renal Impairment, participants with normal renal function |
Primary outcome
The main PK parameters -Time to maximum measured plasma concentration -Tmax
Time frame: Through study completion (approximately Day9)
The main PK parameters -Time to maximum measured plasma concentration -Tmax
Maximum observed plasma concentration-Cmax
Time frame: Through study completion (approximately Day9)
Maximum observed plasma concentration-Cmax
The main PK parameters Half-life -t1/2
Time frame: Through study completion (approximately Day9)
The main PK parameters Half-life -t1/2
The main PK parameters#Area under the plasma concentration versus time curve-AUC
Time frame: Through study completion (approximately Day9)
The main PK parameters#Area under the plasma concentration versus time curve-AUC
The main PK parameters-CL/F (apparent clearance)
Time frame: Through study completion (approximately Day9)
The main PK parameters-CL/F (apparent clearance)
The main PK parameters-Vz/F (apparent volume of distribution)
Time frame: Through study completion (approximately Day9)
The main PK parameters-Vz/F (apparent volume of distribution)
The cumulative excretion amount (Aeu)
Time frame: Through study completion (approximately Day9)
The cumulative excretion (Aeu) of D - 2570 and its metabolites in urine
The fraction of drug excreted in urine (Feu)
Time frame: Through study completion (approximately Day9)
The fraction of drug excreted in urine (Feu) of D - 2570 and its metabolites in urine
The renal clearance rate (CLR)
Time frame: Through study completion (approximately Day9)
The renal clearance rate (CLR)of D - 2570 and its metabolites in urine
1 secondary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v6.0
Time frame: Through study completion (approximately Day9)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- 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.
Huan Zhou, Doctor principal investigator
The First Affiliated Hospital of Anhui Medical University
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 D-2570 in people with Renal Impairment, run by InventisBio Co., Ltd at 1 site in China.
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 4 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 13 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huan Zhou, Doctor (13665527160, zhouhuanbest@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The main PK parameters -Time to maximum measured plasma concentration -Tmax (time frame: Through study completion (approximately Day9)). The study lists 9 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 13 Oct 2026.