Study of Aldafermin (NGM282) in Participants With Impaired Renal Function

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

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.

Study Overview

• Status: Completed
• Conditions: Impaired Renal Function
• Intervention / Treatment: Biological: Aldafermin (NGM282)

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33014
      • NGM Clinical Study Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Current diagnosis of stable chronic kidney disease and eGFR, as assessed by the Modification of Diet in Renal Disease (MDRD) estimate:

  1. Mild renal impairment: eGFR 60-89 mL/min/1.73m²
  2. Moderate renal impairment: eGFR 30-59 mL/min/1.73m²
  3. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aldafermin (NGM282); Administered by subcutaneous injection	Biological: Aldafermin (NGM282); Single 3 mg dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum observed plasma concentration (Cmax) of aldafermin (Day 1 through Day 4)	12 Days
Area under the concentration-time curve from time zero extrapolated to infinity (AUC 0-infinity) of aldafermin (Day 1 through Day 4)	12 Days

Secondary Outcome Measures

Outcome Measure	Time Frame
Type and frequency of Adverse Events (Day 1 through Day 11)	12 Days

Collaborators and Investigators

• Sponsor: NGM Biopharmaceuticals, Inc
• Investigators: Study Director: NGM Study Director, NGM Biopharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2019
• Primary Completion (Actual): December 4, 2019
• Study Completion (Actual): December 14, 2019

Study Registration Dates

• First Submitted: November 12, 2019
• First Submitted That Met QC Criteria: November 25, 2019
• First Posted (Actual): November 27, 2019

Study Record Updates

• Last Update Posted (Actual): April 27, 2020
• Last Update Submitted That Met QC Criteria: April 24, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency
• Other Study ID Numbers: 282-RI-103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No