Study of Aldafermin (NGM282) in Participants With Impaired Renal Function
Primary Purpose
Impaired Renal Function
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Aldafermin (NGM282)
Sponsored by
About this trial
This is an interventional treatment trial for Impaired Renal Function
Eligibility Criteria
Inclusion Criteria:
Current diagnosis of stable chronic kidney disease and eGFR, as assessed by the Modification of Diet in Renal Disease (MDRD) estimate:
- Mild renal impairment: eGFR 60-89 mL/min/1.73m²
- Moderate renal impairment: eGFR 30-59 mL/min/1.73m²
- Severe renal impairment: eGFR < 30 mL/min/1.73m²
- Healthy control subjects with normal renal function will be matched (age ± 10 years; sex, race, BMI ± 15%) to their respective subject in the impaired renal function groups and have eGFR ≥90 mL/min/1.73m . Healthy control subjects should have no systemic chronic disease.
- Males and Females age 18-75
- Body mass index (BMI) 25-40 kg/m²
Exclusion Criteria:
- Renal allograft recipients
- History of renal cell carcinoma or any history of metastatic disease involving the kidney
- End Stage Renal disease, requiring or not requiring dialysis
- Subject requiring or anticipated requirement of dialysis within 3 months of study entry
- Diagnosis of acute kidney injury/acute renal failure, or hospitalization for kidney related issue within 3 months of Screening
- Any renal disease or related condition actively being treated other than chronic kidney disease
- Any acute disease or condition being treated by medical therapy (prescription or over the counter) known to possibly impact renal function within 2 weeks of Screening
- History of treatment for a chronic condition with a medication that is known to have nephrotoxic potential, and after treatment, renal function/status has not been fully evaluated
- Uncontrolled hypertension
- Uncontrolled diabetes
Sites / Locations
- NGM Clinical Study Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Aldafermin (NGM282)
Arm Description
Administered by subcutaneous injection
Outcomes
Primary Outcome Measures
Maximum observed plasma concentration (Cmax) of aldafermin (Day 1 through Day 4)
Area under the concentration-time curve from time zero extrapolated to infinity (AUC 0-infinity) of aldafermin (Day 1 through Day 4)
Secondary Outcome Measures
Type and frequency of Adverse Events (Day 1 through Day 11)
Full Information
NCT ID
NCT04179630
First Posted
November 12, 2019
Last Updated
April 24, 2020
Sponsor
NGM Biopharmaceuticals, Inc
1. Study Identification
Unique Protocol Identification Number
NCT04179630
Brief Title
Study of Aldafermin (NGM282) in Participants With Impaired Renal Function
Official Title
A Phase 1, Single-center, Open Label, Parallel Group Study to Evaluate the Pharmacokinetics, Safety & Tolerability of a Single Dose of Aldafermin (NGM282) in Subjects With Impaired Renal Function
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
November 8, 2019 (Actual)
Primary Completion Date
December 4, 2019 (Actual)
Study Completion Date
December 14, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NGM Biopharmaceuticals, Inc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a single-center evaluation of Aldafermin (NGM282) in an open-label, single-dose and parallel group study in participants with Impaired Renal Function.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impaired Renal Function
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aldafermin (NGM282)
Arm Type
Experimental
Arm Description
Administered by subcutaneous injection
Intervention Type
Biological
Intervention Name(s)
Aldafermin (NGM282)
Intervention Description
Single 3 mg dose
Primary Outcome Measure Information:
Title
Maximum observed plasma concentration (Cmax) of aldafermin (Day 1 through Day 4)
Time Frame
12 Days
Title
Area under the concentration-time curve from time zero extrapolated to infinity (AUC 0-infinity) of aldafermin (Day 1 through Day 4)
Time Frame
12 Days
Secondary Outcome Measure Information:
Title
Type and frequency of Adverse Events (Day 1 through Day 11)
Time Frame
12 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Current diagnosis of stable chronic kidney disease and eGFR, as assessed by the Modification of Diet in Renal Disease (MDRD) estimate:
Mild renal impairment: eGFR 60-89 mL/min/1.73m²
Moderate renal impairment: eGFR 30-59 mL/min/1.73m²
Severe renal impairment: eGFR < 30 mL/min/1.73m²
Healthy control subjects with normal renal function will be matched (age ± 10 years; sex, race, BMI ± 15%) to their respective subject in the impaired renal function groups and have eGFR ≥90 mL/min/1.73m . Healthy control subjects should have no systemic chronic disease.
Males and Females age 18-75
Body mass index (BMI) 25-40 kg/m²
Exclusion Criteria:
Renal allograft recipients
History of renal cell carcinoma or any history of metastatic disease involving the kidney
End Stage Renal disease, requiring or not requiring dialysis
Subject requiring or anticipated requirement of dialysis within 3 months of study entry
Diagnosis of acute kidney injury/acute renal failure, or hospitalization for kidney related issue within 3 months of Screening
Any renal disease or related condition actively being treated other than chronic kidney disease
Any acute disease or condition being treated by medical therapy (prescription or over the counter) known to possibly impact renal function within 2 weeks of Screening
History of treatment for a chronic condition with a medication that is known to have nephrotoxic potential, and after treatment, renal function/status has not been fully evaluated
Uncontrolled hypertension
Uncontrolled diabetes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
NGM Study Director
Organizational Affiliation
NGM Biopharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
NGM Clinical Study Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Study of Aldafermin (NGM282) in Participants With Impaired Renal Function
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