HemodialysisPhase 1NCT04958187
Study to Evaluate the Pharmacokinetics of ANG-3777 in Hemodialysis Subjects
A Phase 1 study testing ANG-3777 in people with Hemodialysis, run by Angion Biomedica Corp at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the pharmacokinetics and safety of a single-dose of ANG-3777 in subjects with renal failure receiving maintenance hemodialysis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hemodialysis
- What is being tested?
- ANG-3777
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2021to Oct 2021
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male or female subjects, 18 to 75 years of age at time of informed consent who have been on maintenance HD 3 times a week for at least 3 months prior to signing informed consent.
- Must receive HD 3 times a week.
- Target post-dialysis body weight < 125 kg.
- Have laboratory parameters at Screening as follows:
- Serum albumin ≥ 3.0 g/dL
- Blood hemoglobin ≥ 9.0 g/dL
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- Serum liver transaminases (alanine aminotransferase [ALT], aspartate aminotransferase [AST]) < 2× the upper limit of normal
- Have adequate single pool urea (Kt/V ≥ 1.2) for the 2 consecutive readings in the months preceding the Screening Visit.
- Subjects will not be allowed to start any new medications during the study period (i.e., from treatment assignment to the follow-up visit) except in case of a medical emergency (the subject may be removed from the study accordingly as decided by the Principal Investigator [PI] and sponsor).
- Subjects should be on stable doses of medications for at least 2 weeks preceding check-in to the research unit except medications used to manage co-morbidities associated with dialysis, e.g., Epogen, vitamin D analogs, and Venofer.
- Women of childbearing potential will not be breast feeding and must have a negative serum pregnancy test at Screening and Day -1.
- Women of childbearing potential must use 2 forms of effective birth control (at least one barrier method) during the study and for 31 days after end of infusion. Men will be required to use condoms for the duration of study and for 7 days after study discharge.
- In the opinion of the investigator, the subject is capable of understanding and complying with the protocol. Subjects must have signed and dated the ICF prior to performance of any study related procedure including Screening procedures.
- Must be receiving HD via an arterio-venous fistula or an arterio-venous graft with no access procedure performed within 1 month prior to receiving study drug.
Who cannot join
- Subjects treated with the cytochrome P450 1A2 (CYP1A2) inhibitors ciprofloxacin (Cipro®) or fluvoxamine (Luvox®) within 14 days prior to anticipated first dose of study medication.
- Ongoing infections or the use of anti-infective medications within 2 weeks prior to Screening.
- History of previous organ transplant or known liver disease.
- Have ongoing drug abuse/dependence (including alcohol) or recent history (within the past 5 years) of, or treatment for, alcohol or drug abuse.
- Positive serum test for alcohol at Screening or on Day -1.
- Positive drugs of abuse test at Screening (serum) or on Day -1 (saliva).
- Current smokers who smoke > 5 cigarettes a day (serum cotinine levels ≥ 10 ng/mL) are excluded. Note: Cotinine is tested at Screening only. Every effort should be made to recruit nonsmokers; at least 8 subjects in this study should be nonsmokers.
- Subjects with an active malignancy, suspicion of active malignancy by history or physical examination, or history of solid, metastatic, or hematologic malignancy with the exception of basal or squamous cell carcinoma of the skin that has been removed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hennepin County Medical Center (HCMC)
Minneapolis, Minnesota, 55415
Daniel K. Ries, MD, 651-641-2900, dries@kidney-mn.com
About this study
Official title: An Open Label, Single-Dose Study to Evaluate the Safety and Pharmacokinetics of ANG-3777 Injected Intravenously in Stable Adult Maintenance Hemodialysis Subjects
The purpose of this study is to evaluate the pharmacokinetics and safety of a single-dose of ANG-3777 in subjects with renal failure receiving maintenance hemodialysis.
- Conditions
- Hemodialysis
- Being tested
- ANG-3777
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANG-3777Drug
Also called Hepatocyte growth factor mimetic
Arm assigned to this intervention will receive 2 mg/kg, IV
| Study group | Role | What they receive |
|---|---|---|
| ANG-3777 | Experimental | Administered IV as a single dose over 30 minutes on Day 1, greater than 24 hours before receiving scheduled hemodialysis (HD). Receives: Drug: ANG-3777 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the pharmacokinetic (PK) parameters of a single dose of ANG-3777 including, but not limited to: Tmax
Measured: Day 1 and Day 2
Measure the pharmacokinetic (PK) parameters of a single dose of ANG-3777 including, but not limited to: Cmax
Measured: Day 1 and Day 2
Measure the pharmacokinetic (PK) parameters of a single dose of ANG-3777 including, but not limited to: AUC(0-last) and AUC(0-inf)
Measured: Day 1 and Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study startJul 2021 (estimated)
- Primary completionOct 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodialysisStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Angion Biomedica Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nucleus Network Ltd
- Responsible party
- Sponsor
- Investigators
- Daniel K. Ries, MD, Principal investigator, Nucleus Network Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04958187
- Sponsor's protocol ID
- ANG3777-HD-103
- Status last verified
- Jun 2021
- First submitted
- 30 Jun 2021
- Last updated
- 15 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Single-Dose Study to Evaluate the Safety and Pharmacokinetics of ANG-3777 Injected Intravenously in Stable Adult Maintenance Hemodialysis Subjects
- ClinicalTrials.gov ID
- NCT04958187
- Acronym / sponsor ID
- ANG3777-HD-103
- Conditions
- Hemodialysis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Angion Biomedica CorpIndustry (pharma, biotech, devices)
- Collaborators
- Nucleus Network Ltd
- Study start
- Jul 2021 (estimated)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 12 Jul 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 purpose of this study is to evaluate the pharmacokinetics and safety of a single-dose of ANG-3777 in subjects with renal failure receiving maintenance hemodialysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ANG-3777 | Experimental | Drug: ANG-3777Administered IV as a single dose over 30 minutes on Day 1, greater than 24 hours before receiving scheduled hemodialysis (HD). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Adult male or female subjects, 18 to 75 years of age at time of informed consent who have been on maintenance HD 3 times a week for at least 3 months prior to signing informed consent.
- Must receive HD 3 times a week.
- Target post-dialysis body weight < 125 kg.
- Have laboratory parameters at Screening as follows:
- Have adequate single pool urea (Kt/V ≥ 1.2) for the 2 consecutive readings in the months preceding the Screening Visit.
Key exclusion criteria (8 listed)
- Subjects treated with the cytochrome P450 1A2 (CYP1A2) inhibitors ciprofloxacin (Cipro®) or fluvoxamine (Luvox®) within 14 days prior to anticipated first dose of study medication.
- Ongoing infections or the use of anti-infective medications within 2 weeks prior to Screening.
- History of previous organ transplant or known liver disease.
- Have ongoing drug abuse/dependence (including alcohol) or recent history (within the past 5 years) of, or treatment for, alcohol or drug abuse.
- Positive serum test for alcohol at Screening or on Day -1.
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 |
|---|---|---|
| ANG-3777Also: Hepatocyte growth factor mimeticArm assigned to this intervention will receive 2 mg/kg, IV | Drug | ANG-3777 |
Primary outcome
Measure the pharmacokinetic (PK) parameters of a single dose of ANG-3777 including, but not limited to: Tmax
Time frame: Day 1 and Day 2
Measure the pharmacokinetic (PK) parameters of a single dose of ANG-3777 including, but not limited to: Cmax
Time frame: Day 1 and Day 2
Measure the pharmacokinetic (PK) parameters of a single dose of ANG-3777 including, but not limited to: AUC(0-last) and AUC(0-inf)
Time frame: Day 1 and Day 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2021.
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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.
Daniel K. Ries, MD principal investigator
Nucleus Network Ltd
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 ANG-3777 in people with Hemodialysis, run by Angion Biomedica Corp 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 14 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 15 Jul 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chantal Swiszcz (857-378-4175, cswiszcz@angion.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure the pharmacokinetic (PK) parameters of a single dose of ANG-3777 including, but not limited to: Tmax (time frame: Day 1 and Day 2). 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 15 Jul 2021.