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

NCT ID: NCT04958187

Last Updated: 2021-07-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-31
• Study Completion Date: 2021-10-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ANG-3777

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

Group Type: EXPERIMENTAL

ANG-3777

Intervention Type: DRUG

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

Interventions

ANG-3777

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

Intervention Type: DRUG

Other Intervention Names

Hepatocyte growth factor mimetic

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nucleus Network Ltd

OTHER

Sponsor Role: collaborator

Angion Biomedica Corp

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel K. Ries, MD

Role: PRINCIPAL_INVESTIGATOR

Nucleus Network Ltd

Locations

Hennepin County Medical Center (HCMC)

Minneapolis, Minnesota, United States

Countries

United States

Central Contacts

Chantal Swiszcz

Role: CONTACT

cswiszcz@angion.com

857-378-4175

Martin Robledo

Role: CONTACT

mrobledo@angion.com

857-378-4173

Facility Contacts

Daniel K. Ries, MD

Role: primary

dries@kidney-mn.com

651-641-2900

Other Identifiers

ANG3777-HD-103

Identifier Type: -

Identifier Source: org_study_id