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A Study to Test How Kidney Problems Influence the Blood Concentrations of Efgartigimod

Primary Purpose

Renal Impairment

Status
Recruiting
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Efgartigimod IV
Sponsored by
argenx
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Renal Impairment

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Participant is at least 18 and ≤80 years of age when signing the informed consent form, and willing and able to understand and comply with the requirements of the study Participant has BMI ≥18.0 and ≤38.0 kg/m2 Female participant of childbearing potential agrees to contraceptive use consistent with local regulations for clinical studies and has a negative serum pregnancy test Participant has a stable diagnosis of RI, without any significant change in overall disease status in the 3 months before screening At screening, the participant has eGFR (mL/min) calculated using the CKD-EPI equation that is within the following ranges: 60 to <90 (mild RI); 30 to <60 (moderate RI); <30 (severe RI not requiring dialysis); ≥90 (normal renal function) Participant has normal or not clinically significant findings in physical examination, vital signs, ECG, and clinical laboratory evaluations; exceptions may be granted for findings consistent with the participant's RI or other related stable diseases Absence of clinically significant illness and surgery during the 4 weeks before the infusion and absence of clinically significant history of hematologic, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, and immunologic disease Participant with RI is receiving a stable medical regimen for 14 days before the efgartigimod infusion, except for routine daily management of electrolytes (eg, potassium), acid-base, or other electrolyte abnormalities associated with RI. Control participant agrees to not receive any medications, except contraceptives and occasional paracetamol use Exclusion Criteria: Participant has previously participated in an efgartigimod clinical study and received at least 1 dose Participant has a known hypersensitivity to 1 of the components in efgartigimod IV or a history of severe allergic or anaphylactic reactions Participant has a condition except for RI that could affect efgartigimod PK Participant has a clinically significant unstable medical condition or history of any illness that can increase the risk associated with study participation or efgartigimod administration or can interfere with the interpretation of study results and make the participant inappropriate for this study. Participant has a positive nasopharyngeal swab test for SARS-CoV-2 on day -1 Participant has supine 12-lead ECG abnormalities at screening considered clinically significant and clinically significant vital sign abnormalities Participant has a history of significant drug or alcohol abuse within 6 months before screening, or positive urine drug screen or alcohol test at screening Participant has a history of malignancy unless considered to be cured by adequate treatment with no evidence of recurrence for ≥3 years before the efgartigimod infusion. Participants with the following cancers can be included at any time, provided they are adequately treated before they participate in the study: Basal cell or squamous cell skin cancer, Carcinoma in situ of the cervix, Incidental histological finding of prostate cancer Participant has a clinically significant active or chronic, bacterial, viral, or fungal infection at screening, including a positive serum test at screening for active infection with any of the following conditions: HBV indicative of an acute or chronic infection unless associated with a negative HBsAg or negative HBV DNA test, HCV based on HCV antibody assay unless an RNA test indicates the participant is HCV negative, HIV based on CD4 count <200 cells/mm3 associated with an AIDS-defining condition, HIV based on CD4 count greater than 200 cells/mm3 not adequately treated with antiretroviral therapy Participant has participated in a clinical study involving the administration of an IMP or marketed drug or device within 30 days of the infusion, administration of a biological product in the context of a clinical study within 90 days of the infusion, or concurrent participation in an investigational study involving no drug or device administration Participant is an employee of the investigator or study site with direct involvement in this clinical study or other studies under the direction of the investigator or study site or a family member of an employee of the investigator Female participant has a positive pregnancy test before dosing or is pregnant or breastfeeding Participant has had a renal transplant Participant has received any new prescription medication before the efgartigimod infusion or other medication, except those approved by the investigator

Sites / Locations

  • Investigator site 2Recruiting
  • Investigator site 1Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Mild renal impairment

Moderate renal impairment

Severe renal impairment

Normal renal function

Arm Description

Patients with 60 <= eGFR <90

Patients with 30 <= eGFR <60

Patients with eGFR <30

Patients with eGFR >=90

Outcomes

Primary Outcome Measures

Efgartigimod PK parameters (Cmax)

Secondary Outcome Measures

Efgartigimod urine concentrations
Incidence of serious adverse events
Reduction from baseline in total IgG levels over time
Incidence of ADA to efgartigimod

Full Information

First Posted
June 22, 2023
Last Updated
August 14, 2023
Sponsor
argenx
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1. Study Identification

Unique Protocol Identification Number
NCT05927415
Brief Title
A Study to Test How Kidney Problems Influence the Blood Concentrations of Efgartigimod
Official Title
A Phase 1, Open-label, Study to Evaluate the Pharmacokinetics of Efgartigimod IV 10 mg/kg Single Dose Administered in Participants With Renal Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 17, 2023 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
argenx

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A study to test how kidney problems influence the blood concentrations of efgartigimod

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Impairment

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mild renal impairment
Arm Type
Experimental
Arm Description
Patients with 60 <= eGFR <90
Arm Title
Moderate renal impairment
Arm Type
Experimental
Arm Description
Patients with 30 <= eGFR <60
Arm Title
Severe renal impairment
Arm Type
Experimental
Arm Description
Patients with eGFR <30
Arm Title
Normal renal function
Arm Type
Experimental
Arm Description
Patients with eGFR >=90
Intervention Type
Biological
Intervention Name(s)
Efgartigimod IV
Intervention Description
Intravenous infusion of efgartigimod
Primary Outcome Measure Information:
Title
Efgartigimod PK parameters (Cmax)
Time Frame
up to 64 days
Secondary Outcome Measure Information:
Title
Efgartigimod urine concentrations
Time Frame
up to 64 days
Title
Incidence of serious adverse events
Time Frame
up to 64 days
Title
Reduction from baseline in total IgG levels over time
Time Frame
up to 64 days
Title
Incidence of ADA to efgartigimod
Time Frame
up to 64 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Participant is at least 18 and ≤80 years of age when signing the informed consent form, and willing and able to understand and comply with the requirements of the study Participant has BMI ≥18.0 and ≤38.0 kg/m2 Female participant of childbearing potential agrees to contraceptive use consistent with local regulations for clinical studies and has a negative serum pregnancy test Participant has a stable diagnosis of RI, without any significant change in overall disease status in the 3 months before screening At screening, the participant has eGFR (mL/min) calculated using the CKD-EPI equation that is within the following ranges: 60 to <90 (mild RI); 30 to <60 (moderate RI); <30 (severe RI not requiring dialysis); ≥90 (normal renal function) Participant has normal or not clinically significant findings in physical examination, vital signs, ECG, and clinical laboratory evaluations; exceptions may be granted for findings consistent with the participant's RI or other related stable diseases Absence of clinically significant illness and surgery during the 4 weeks before the infusion and absence of clinically significant history of hematologic, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, and immunologic disease Participant with RI is receiving a stable medical regimen for 14 days before the efgartigimod infusion, except for routine daily management of electrolytes (eg, potassium), acid-base, or other electrolyte abnormalities associated with RI. Control participant agrees to not receive any medications, except contraceptives and occasional paracetamol use Exclusion Criteria: Participant has previously participated in an efgartigimod clinical study and received at least 1 dose Participant has a known hypersensitivity to 1 of the components in efgartigimod IV or a history of severe allergic or anaphylactic reactions Participant has a condition except for RI that could affect efgartigimod PK Participant has a clinically significant unstable medical condition or history of any illness that can increase the risk associated with study participation or efgartigimod administration or can interfere with the interpretation of study results and make the participant inappropriate for this study. Participant has a positive nasopharyngeal swab test for SARS-CoV-2 on day -1 Participant has supine 12-lead ECG abnormalities at screening considered clinically significant and clinically significant vital sign abnormalities Participant has a history of significant drug or alcohol abuse within 6 months before screening, or positive urine drug screen or alcohol test at screening Participant has a history of malignancy unless considered to be cured by adequate treatment with no evidence of recurrence for ≥3 years before the efgartigimod infusion. Participants with the following cancers can be included at any time, provided they are adequately treated before they participate in the study: Basal cell or squamous cell skin cancer, Carcinoma in situ of the cervix, Incidental histological finding of prostate cancer Participant has a clinically significant active or chronic, bacterial, viral, or fungal infection at screening, including a positive serum test at screening for active infection with any of the following conditions: HBV indicative of an acute or chronic infection unless associated with a negative HBsAg or negative HBV DNA test, HCV based on HCV antibody assay unless an RNA test indicates the participant is HCV negative, HIV based on CD4 count <200 cells/mm3 associated with an AIDS-defining condition, HIV based on CD4 count greater than 200 cells/mm3 not adequately treated with antiretroviral therapy Participant has participated in a clinical study involving the administration of an IMP or marketed drug or device within 30 days of the infusion, administration of a biological product in the context of a clinical study within 90 days of the infusion, or concurrent participation in an investigational study involving no drug or device administration Participant is an employee of the investigator or study site with direct involvement in this clinical study or other studies under the direction of the investigator or study site or a family member of an employee of the investigator Female participant has a positive pregnancy test before dosing or is pregnant or breastfeeding Participant has had a renal transplant Participant has received any new prescription medication before the efgartigimod infusion or other medication, except those approved by the investigator
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Information:
Facility Name
Investigator site 2
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 1
City
Munich
ZIP/Postal Code
81241
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com

12. IPD Sharing Statement

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A Study to Test How Kidney Problems Influence the Blood Concentrations of Efgartigimod

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