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

NGM Biopharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Impaired Renal Function

Treatments: Biological: Aldafermin (NGM282)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04179630

282-RI-103

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

Aldafermin (NGM282)

Experimental group

Description:

Administered by subcutaneous injection

Treatment:

Biological: Aldafermin (NGM282)