Chronic Kidney DiseasePhase 1NCT04699032
Study of Pharmacokinetics and Safety of Apraglutide in Participants With Normal and Impaired Kidney Function.
A Phase 1 study testing Apraglutide in people with Chronic Kidney Disease, run by VectivBio AG at 2 sites in United States.
Trial summary
Study of pharmacokinetics and safety of apraglutide in participants with normal and impaired kidney function. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Apraglutide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Dec 2020to 5 Jul 2021
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Participants
- Age between 18 and 75 years inclusive
- Subjects who are willing and able to comply with the study procedures
- Subjects able to understand and willing to sign the informed consent
- Body mass index (BMI) of ≥17.5 to ≤40 kg/m2; and a total body weight of >50 kg (110 lb).
- Women of childbearing potential (WOCBP) on highly effective method of contraception during the trial and for 1 month after the end of trial (EOT) visit. Sterilized or infertile or postmenopausal females.
Show all 15Show fewer
- Male subjects with a female partner of childbearing potential: highly effective methods of contraception and no sperm donation during the trial and for 1 month after (EOT) visit.
- Healthy participants
- No clinically relevant abnormalities (medical history, vital signs, ECG, safety labs)
- eGFR measured by CKD-EPI ≥90 mL/min/1.73 m2) at two screening visits
- Demographically comparable to the group of subjects with impaired renal function:
- Participants with impaired renal function
- Severe renal impairment: eGFR <30 mL/min/1.73 m2, but not requiring hemodialysis
- Moderate renal impairment: eGFR ≥30 mL/min/1.73 m2 and <60 mL/min/1.73 m2
- Mild renal impairment: eGFR ≥60 and <90 mL/min/1.73 m2
Who cannot join
- All Subjects
- Renal transplant recipients
- History of systemic infection
- Any active malignancies or history of malignancies within the past 2 years
- Acute or chronic medical or psychiatric condition
- Treatment with an IMP within 30 days or 5 half-lives (whichever is longer) preceding the dose of IMP
Show all 28Show fewer
- Male subjects partners of WOCBP who are unable to comply with the contraceptive measures
- History of clinically significant intestinal adhesions and/or chronic abdominal pain
- History of known colon polyps or family history of familial adenomatous polyposis
- Positive blood screen for hepatitis C antibody, hepatitis B surface antigen or human immunodeficiency virus (HIV)-1 and -2 antibodies
- Serum albumin concentration <25 g/L (2.5 g/dL)
- Hemoglobin concentration <90 g/L (9.0 g/dL)
- Aspartate amino transaminase (AST) or alanine amino transaminase (ALT) values >2 × upper limit of normal (ULN)
- Proteinuria of >3 g total bilirubin >1.5 × ULN
- Positive urine test for alcohol or illicit drugs at either Screening or admission.
- Clinically significant abnormalities on 12-lead ECG
- Use of prescription or non-prescription drugs and dietary supplements within 7 days or five half-lives (whichever is longer) prior to Day 1. Stable concomitant medications may be given to subjects with renal impairment, if they are considered necessary for the welfare of the subjects.
- History of regular alcohol consumption exceeding seven drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces [150 mL] of wine, or 12 ounces [360 mL] of beer, or 1.5 ounces [45 mL] of hard liquor) within 3 months of Screening
- Female subjects of childbearing potential who are unwilling or unable to use highly effective methods of contraception for the duration of the trial and for at least 1 month after the administration of the IMP; pregnant female subjects; female subjects planning to become pregnant during the duration of the trial and until 1 month after the administration of the IMP; breastfeeding female subjects
- Blood donation of approximately 500 mL or more within 60 days prior to the dose of IMP. Plasma donations of approximately 500 mL or more within 28 days prior to the dose of IMP
- Additional Exclusion Criteria for Healthy Subjects with Normal Renal Function
- Evidence or history of clinically significant abnormalities
- Evidence or history of clinically significant dermatological condition
- Additional Exclusion Criteria for Subjects with Impaired Renal Function
- Subjects requiring hemodialysis and/or peritoneal dialysis
- Subjects with other clinically significant disease
- Subjects with any significant hepatic, cardiac, or pulmonary disease or subjects who are clinically nephrotic. Hypertension, diabetes mellitus, hyperparathyroidism, ischemic heart disease are not cause for exclusion as long as the subject is medically stable and any drugs that are administered for these conditions are not expected to interfere with the PK of apraglutide.
- Screening BP ≥180 mmHg (systolic) or ≥110 mmHg (diastolic)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Orlando Clinical Research Center
Orlando, Florida, 32809
Prism Clinical Research, Inc.
Saint Paul, Minnesota, 55114
About this study
Official title: A Phase 1, Open-Label Evaluation of the Pharmacokinetics and Safety of a Single Dose of Apraglutide in Subjects With Normal and Impaired Renal Function.
Study of pharmacokinetics and safety of apraglutide in participants with normal and impaired kidney function.
Read the detailed description
A two stage design, open label, multi-center, non-randomized trial to evaluate the PK and safety of a single subcutaneous dose of 5 mg apraglutide in subjects with varying degrees of renal function. The renal function was calculated by the estimated glomerular filtration rate (eGFR) according to the Chronic Kidney Disease Epidemiology (CKD-EPI) Creatinine Equation.
Part 1: 8 subjects with severe renal impairment (Cohort 1) and 8 subjects with normal renal function (Cohort 2).
Part 2: 8 subjects with moderate (Cohort 3) and 8 subjects with mild (Cohort 4). Enrollment into Part 2 was conditional on the results of Part 1.
- Conditions
- Chronic Kidney Disease
- Being tested
- Apraglutide
- Keywords
- Renal Function, Renal Impairment, Kidney Function
- Medical subject headings
- Renal Insufficiency, Chronic, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApraglutideDrug
Single dose of apraglutide 5 mg.
| Study group | Role | What they receive |
|---|---|---|
| Severe Renal Impairment | Experimental | eGFR (mL/min/1.73 m2): <30 not on hemodialysis Receives: Drug: Apraglutide |
| Normal Healthy Match | Experimental | eGFR (mL/min/1.73 m2): ≥90 Receives: Drug: Apraglutide |
| Moderate Renal Impairment | Experimental | eGFR (mL/min/1.73 m2): ≥30 to 60 Receives: Drug: Apraglutide |
| Mild Renal Impairment | Experimental | eGFR (mL/min/1.73 m2): ≥60 to 90 Receives: Drug: Apraglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax) of Apraglutide
Pharmacokinetic (PK) samples collected for the measurement of plasma concentration of apraglutide were analyzed using a validated analytical method in compliance with applicable standard operating procedures.
Measured: 5 minutes pre-dose up to 240 hours after dosing on Day 1
Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) of Apraglutide
PK samples collected for the measurement of plasma concentration of apraglutide were analyzed using a validated analytical method in compliance with applicable standard operating procedures.
Measured: 5 minutes pre-dose up to 240 hours after dosing on Day 1
Secondary outcomes (2)
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
TEAEs were defined as adverse events (AEs) that occurred after dosing the participant with the study drug. Participants with more than one TEAE were counted only once using the most severe event. Vital signs, triplicate 12-lead electrocardiograms, or clinical laboratory assessments considered clinically significant by the Investigator were reported as AEs.
Measured: Day 1 up to Day 14
Number of TEAEs
The Investigator used the adjectives mild, moderate, or severe to describe the maximum intensity of the AE. These were defined as follows:
- Mild: did not interfere with participant's usual function
- Moderate: interfered to some extent with participant's usual function
- Severe: interfered significantly with participant's usual function.
The Investigator systematically assessed the causal relationship of AEs to IMP/trial treatment using the definitions below:
- Not related: Not reasonably related to the IMP. The AE could not medically (pharmacologically/clinically) be attributed to the IMP
- Related: Reasonably related to the IMP. The AE could medically (pharmacologically/clinically) be attributed to the IMP.
A serious AE (SAE) was classified as any AE that:
- Resulted in death
- Was life-threatening
- Required or prolonged in-patient hospitalization
- Resulted in persistent or significant disability/incapacity
- Was a congenital anomaly/birth defect in a neo
Measured: Day 1 up to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start8 Dec 2020
- Primary completion5 Jul 2021
- Study completion5 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- VectivBio AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tomasz Masior, Study director, VectivBio AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04699032
- Sponsor's protocol ID
- TA799-014
- Status last verified
- Jul 2022
- First submitted
- 30 Dec 2020
- Last updated
- 26 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Greig G, Youssef NN, Bolognani F. Pharmacokinetics and Tolerability of a Single Dose of Apraglutide, a Novel, Long-Acting, Synthetic glucagon-like peptide-2 Analog With a Unique Pharmacologic Profile, in Individuals With Impaired Renal Function. J Clin Pharmacol. 2024 Jun;64(6):744-754. doi: 10.1002/jcph.2423. Epub 2024 Mar 11.
PubMed 38465515
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label Evaluation of the Pharmacokinetics and Safety of a Single Dose of Apraglutide in Subjects With Normal and Impaired Renal Function.
- ClinicalTrials.gov ID
- NCT04699032
- Acronym / sponsor ID
- TA799-014
- Conditions
- Chronic Kidney Disease
- Keywords
- Renal Function, Renal Impairment, Kidney Function
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- VectivBio AGIndustry (pharma, biotech, devices)
- Study start
- 8 Dec 2020 (actual)
- Primary completion
- 5 Jul 2021 (actual)
- Study completion
- 5 Jul 2021 (actual)
- First posted
- 7 Jan 2021 (actual)
- Results
- Posted 15 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study of pharmacokinetics and safety of apraglutide in participants with normal and impaired kidney function.
Detailed description
A two stage design, open label, multi-center, non-randomized trial to evaluate the PK and safety of a single subcutaneous dose of 5 mg apraglutide in subjects with varying degrees of renal function. The renal function was calculated by the estimated glomerular filtration rate (eGFR) according to the Chronic Kidney Disease Epidemiology (CKD-EPI) Creatinine Equation.
Part 1: 8 subjects with severe renal impairment (Cohort 1) and 8 subjects with normal renal function (Cohort 2).
Part 2: 8 subjects with moderate (Cohort 3) and 8 subjects with mild (Cohort 4). Enrollment into Part 2 was conditional on the results of Part 1.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Severe Renal Impairment | Experimental | Drug: ApraglutideeGFR (mL/min/1.73 m2): <30 not on hemodialysis |
| Normal Healthy Match | Experimental | Drug: ApraglutideeGFR (mL/min/1.73 m2): ≥90 |
| Moderate Renal Impairment | Experimental | Drug: ApraglutideeGFR (mL/min/1.73 m2): ≥30 to 60 |
| Mild Renal Impairment | Experimental | Drug: ApraglutideeGFR (mL/min/1.73 m2): ≥60 to 90 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- All Participants
- Age between 18 and 75 years inclusive
- Subjects who are willing and able to comply with the study procedures
- Subjects able to understand and willing to sign the informed consent
- Body mass index (BMI) of ≥17.5 to ≤40 kg/m2; and a total body weight of >50 kg (110 lb).
Key exclusion criteria (28 listed)
- All Subjects
- Renal transplant recipients
- History of systemic infection
- Any active malignancies or history of malignancies within the past 2 years
- Acute or chronic medical or psychiatric condition
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 |
|---|---|---|
| ApraglutideSingle dose of apraglutide 5 mg. | Drug | Mild Renal Impairment, Moderate Renal Impairment, Normal Healthy Match, Severe Renal Impairment |
Primary outcome
Maximum Plasma Concentration (Cmax) of Apraglutide
Time frame: 5 minutes pre-dose up to 240 hours after dosing on Day 1
Pharmacokinetic (PK) samples collected for the measurement of plasma concentration of apraglutide were analyzed using a validated analytical method in compliance with applicable standard operating procedures.
Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) of Apraglutide
Time frame: 5 minutes pre-dose up to 240 hours after dosing on Day 1
PK samples collected for the measurement of plasma concentration of apraglutide were analyzed using a validated analytical method in compliance with applicable standard operating procedures.
2 secondary outcomes
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Day 1 up to Day 14
Number of TEAEs
Time frame: Day 1 up to Day 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38465515Greig G, Youssef NN, Bolognani F. Pharmacokinetics and Tolerability of a Single Dose of Apraglutide, a Novel, Long-Acting, Synthetic glucagon-like peptide-2 Analog With a Unique Pharmacologic Profile, in Individuals With Impaired Renal Function. J Clin Pharmacol. 2024 Jun;64(6):744-754. doi: 10.1002/jcph.2423. Epub 2024 Mar 11.
Related trials for Chronic Kidney Disease
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
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
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases
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.
Tomasz Masior study director
VectivBio AG
2 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 Apraglutide in people with Chronic Kidney Disease, run by VectivBio AG at 2 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 15 inclusion and 28 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 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Yes. Results are posted in the registry (first posted 15 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Maximum Plasma Concentration (Cmax) of Apraglutide (time frame: 5 minutes pre-dose up to 240 hours after dosing on Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04699032, which also lists 1 linked publication.
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 26 Oct 2024.