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

Phase 1

Completed

• Conditions: Impaired Renal Function
• Interventions: Biological: Aldafermin (NGM282)

• Registration Number: NCT04179630
• Lead Sponsor: NGM Biopharmaceuticals, Inc

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-08
• Study First Submitted: 2019-11-12
• Study First Submitted QC: 2019-11-25
• Study First Posted: 2019-11-27
• Primary Completion: 2019-12-04
• Study Completion: 2019-12-14
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-24
• Last Update Posted: 2020-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Aldafermin (NGM282)	Aldafermin (NGM282)	Administered by subcutaneous injection

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Type and frequency of Adverse Events (Day 1 through Day 11)	12 Days

Trial Locations

Locations (1)

NGM Clinical Study Site; 🇺🇸 Miami, Florida, United States