ClinicalTrials.gg
Status unknownNCT04958187Updated Jul 15, 2021

Study to Evaluate the Pharmacokinetics of ANG-3777 in Hemodialysis Subjects

A Phase 1 interventional study of ANG-3777 in Hemodialysis, sponsored by Angion Biomedica Corp. Status unknown at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-07-15.

Sponsored by Angion Biomedica Corp · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
16
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hemodialysis
03

In context

Lead sponsor

Angion Biomedica Corp is the lead sponsor of 12 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Adult male or female subjects, 18 to 75 years of age at time of who have been on maintenance HD 3 times a week for at least 3 months prior to signing informed consent.
  2. Must receive HD 3 times a week.
  3. Target post-dialysis body weight \< 125 kg.
  4. Have laboratory parameters at Screening as follows:

    1. Serum albumin ≥ 3.0 g/dL
    2. Blood ≥ 9.0 g/dL
    3. Serum liver transaminases ( [ALT], aspartate aminotransferase [AST]) \< 2× the
  5. Have adequate single pool urea (Kt/V ≥ 1.2) for the 2 consecutive readings in the months preceding the Screening Visit.
  6. 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).
  7. 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.
  8. Women of will not be breast feeding and must have a negative serum pregnancy test at Screening and Day -1.
  9. Women of childbearing potential must use 2 forms of effective (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.
  10. 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.
  11. 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.

Exclusion criteria

Exclusion Criteria:

  1. 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.
  2. Ongoing infections or the use of anti-infective medications within 2 weeks prior to Screening.
  3. History of previous organ transplant or known liver disease.
  4. Have ongoing drug abuse/dependence (including alcohol) or recent history (within the past 5 years) of, or treatment for, alcohol or drug abuse.
  5. Positive serum test for alcohol at Screening or on Day -1.
  6. Positive drugs of abuse test at Screening (serum) or on Day -1 (saliva).
  7. 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.
  8. Subjects with an active , suspicion of active malignancy by history or physical examination, or history of solid, , or hematologic malignancy with the exception of basal or squamous cell carcinoma of the skin that has been removed.
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
16 participants (estimated)

Study arms

  • Experimental
    ANG-3777

    Administered IV as a single dose over 30 minutes on Day 1, greater than 24 hours before receiving scheduled hemodialysis (HD).

    Drug: ANG-3777

Interventions

  • Arm assigned to this intervention will receive 2 mg/kg, IV

    Also known as: Hepatocyte growth factor mimetic

06

What researchers measure

Primary outcomes

  1. 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

  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

  3. 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

07

Study locations

1 site
  • Hennepin County Medical Center (HCMC)
    Minneapolis, Minnesota 55415, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jul 2021; primary completion for Oct 2021, 3 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 30, 2021
First posted
Jul 12, 2021
StartEst.
Jul 2021
Primary completionEst.
Oct 2021
CompletionEst.
Oct 2021
Last update
Jul 15, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 15, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04958187
Lead sponsor
Angion Biomedica Corp
Collaborators
Nucleus Network Ltd
Responsible party
Sponsor
First posted
Jul 12, 2021
Start date
Jul 2021 (estimated)
Primary completion
Oct 2021 (estimated)
Completion
Oct 2021 (estimated)
Last update
Jul 15, 2021

Study contacts

Chantal Swiszcz
Contact
cswiszcz@angion.com
857-378-4175
Martin Robledo
Contact
mrobledo@angion.com
857-378-4173
Daniel K. Ries, MD
principal investigator · Nucleus Network Ltd

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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