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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aldafermin (NGM282) | Experimental | Administered by subcutaneous injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aldafermin (NGM282) | Biological | Single 3 mg dose |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Type and frequency of Adverse Events (Day 1 through Day 11) | 12 Days |
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Inclusion Criteria:
Current diagnosis of stable chronic kidney disease and eGFR, as assessed by the Modification of Diet in Renal Disease (MDRD) estimate:
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:
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| Name | Affiliation | Role |
|---|---|---|
| NGM Study Director | NGM Biopharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NGM Clinical Study Site | Miami | Florida | 33014 | United States |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C000710649 | aldafermin |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |