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

Hemodialysis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04958187
• Other study ID #: ANG3777-HD-103
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: July 2021
• Est. completion date: October 2021

Study information

• Verified date: June 2021
• Source: Angion Biomedica Corp
• Contact: Chantal Swiszcz
• Phone: 857-378-4175
• Email: cswiszcz[@]angion.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 16
• Est. completion date: October 2021
• Est. primary completion date: October 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. 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.

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 hemoglobin = 9.0 g/dL

3. Serum liver transaminases (alanine aminotransferase [ALT], aspartate aminotransferase [AST]) < 2× the upper limit of normal

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 childbearing potential 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 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.

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:

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 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.

Related Conditions & MeSH terms

• Hemodialysis

Intervention

Drug:
• ANG-3777
Arm assigned to this intervention will receive 2 mg/kg, IV

Locations

Country	Name	City	State
United States	Hennepin County Medical Center (HCMC)	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Angion Biomedica Corp	Nucleus Network Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure the pharmacokinetic (PK) parameters of a single dose of ANG-3777 including, but not limited to: Tmax		Day 1 and Day 2
Primary	Measure the pharmacokinetic (PK) parameters of a single dose of ANG-3777 including, but not limited to: Cmax		Day 1 and Day 2
Primary	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