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

NCT04179630 | Completed Phase 1 FDA Drug

• 1 other identifier: 282-RI-103
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Type and frequency of Adverse Events (Day 1 through Day 11)

  12 Days

Study Arms (1)

Aldafermin (NGM282)

EXPERIMENTAL

Administered by subcutaneous injection

Biological: Aldafermin (NGM282)

Interventions

Aldafermin (NGM282) BIOLOGICAL

Single 3 mg dose

Aldafermin (NGM282)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NGM Biopharmaceuticals, Inc: lead

Study Sites (1)

NGM Clinical Study Site

Miami, Florida, 33014, United States

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

aldafermin

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• NGM Study Director

  NGM Biopharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2019
• First Posted: November 27, 2019
• Study Start: November 8, 2019
• Primary Completion: December 4, 2019
• Study Completion: December 14, 2019
• Last Updated: April 27, 2020

Record last verified: 2020-04

Locations

US (1)