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

Impaired Renal Function Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04179630
• Other study ID #: 282-RI-103
• Status: Completed
• Phase: Phase 1
• Start date: November 8, 2019
• Est. completion date: December 14, 2019

Study information

• Verified date: April 2020
• Source: NGM Biopharmaceuticals, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 14, 2019
• Est. primary completion date: December 4, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Impaired Renal Function
• Renal Insufficiency

Intervention

Biological:
• Aldafermin (NGM282)
Single 3 mg dose

Locations

Country	Name	City	State
United States	NGM Clinical Study Site	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
NGM Biopharmaceuticals, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed plasma concentration (Cmax) of aldafermin (Day 1 through Day 4)		12 Days
Primary	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	Type and frequency of Adverse Events (Day 1 through Day 11)		12 Days