Study of Aldafermin (NGM282) in Participants With Impaired Renal Function
Completed · Phase 1
Conditions studied: Impaired Renal Function
In brief
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.
Key facts
- Study ID
- NCT04179630
- Run by
- NGM Biopharmaceuticals, Inc
- People needed
- 48
- Starts
- 2019-11-08
- Expected to finish
- 2019-12-14
- Last updated by the study team
- 2020-04-27
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.
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
Where it is running
- NGM Clinical Study Site — Miami, Florida, United States
Full record on ClinicalTrials.gov
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