Impaired Renal Function
Conditions
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.
Interventions
BIOLOGICALAldafermin (NGM282)
Single 3 mg dose
Sponsors
NGM Biopharmaceuticals, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Type and frequency of Adverse Events (Day 1 through Day 11) | 12 Days |
Countries
United States
Outcome results
None listed