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

NCT ID: NCT04179630

Last Updated: 2020-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-08
• Study Completion Date: 2019-12-14

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.

Conditions

Impaired Renal Function

Study Design

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

Study Groups

Aldafermin (NGM282)

Administered by subcutaneous injection

Group Type: EXPERIMENTAL

Aldafermin (NGM282)

Intervention Type: BIOLOGICAL

Single 3 mg dose

Interventions

Aldafermin (NGM282)

Single 3 mg dose

Intervention Type: BIOLOGICAL

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:

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

NGM Biopharmaceuticals, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

NGM Study Director

Role: STUDY_DIRECTOR

NGM Biopharmaceuticals

Locations

NGM Clinical Study Site

Miami, Florida, United States

Countries

United States

Other Identifiers

282-RI-103

Identifier Type: -

Identifier Source: org_study_id