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NCT Number: NCT04179630

Study of Aldafermin (NGM282) in Participants 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.

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Key information

Conditions

Impaired Renal Function Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

NGM Clinical Study Site

Miami, Florida, 33014, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aldafermin (NGM282)

Biological

Single 3 mg dose

Primary outcomes

  1. Maximum observed plasma concentration (Cmax) of aldafermin (Day 1 through Day 4)

    Time frame: 12 Days

  2. 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 outcomes

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

    Time frame: 12 Days

Sponsors and collaborators

Lead sponsor

NGM Biopharmaceuticals, Inc

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Nov 27, 2019
Registry last updated
Apr 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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