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

NCT04958187 | Unknown Phase 1 FDA Drug

• 1 other identifier: ANG3777-HD-103
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hemodialysis

Outcome Measures

Primary Outcomes (3)

• Measure the pharmacokinetic (PK) parameters of a single dose of ANG-3777 including, but not limited to: Tmax

  Day 1 and Day 2

• Measure the pharmacokinetic (PK) parameters of a single dose of ANG-3777 including, but not limited to: Cmax

  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)

  Day 1 and Day 2

Study Arms (1)

ANG-3777

EXPERIMENTAL

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

ANG-3777 DRUG

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

Also known as: Hepatocyte growth factor mimetic

ANG-3777

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Angion Biomedica Corp: lead
• Nucleus Network Ltd: collaborator

Study Sites (1)

Hennepin County Medical Center (HCMC)

Minneapolis, Minnesota, 55415, United States

Location

MeSH Terms

Interventions

terevalefim

Study Officials

• Daniel K. Ries, MD

  Nucleus Network Ltd

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chantal Swiszcz

CONTACT

857-378-4175; cswiszcz@angion.com

Martin Robledo

CONTACT

857-378-4173; mrobledo@angion.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2021
• First Posted: July 12, 2021
• Study Start: July 1, 2021
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: July 15, 2021

Record last verified: 2021-06

Locations

US (1)