A Study of Inclisiran in Participants With Renal Impairment Compared to Participants With Normal Renal Function (ORION-7)

The Medicines Company

Status and phase: Completed; Phase 1

Conditions: Renal Impairment

Treatments: Drug: Inclisiran

Study type: Interventional

Funder types: Industry

Identifiers

NCT03159416

MDCO-PCS-16-03

Details and patient eligibility

About

This study is a Phase I, single-dose, open-label trial to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of a single dose of inclisiran subcutaneous (SC) injection in participants with mild, moderate, and severe renal impairment compared to participants with normal renal function.

Enrollment: 31 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male and female participants 18 to 80 years of age
• Participants should be qualified for inclusion based upon estimated CrCl ranges for normal renal function group and mild, moderate, and severe renal impairment groups

Exclusion criteria

• Participants with acute renal disease and/or history of renal transplant
• Urinary incontinence without catheterization
• Participants requiring hemodialysis
• Participants with LDL-C <60 mg/deciliter (dL) (or less than 1.55 millimoles/liter [mmol/L])
• Participants with Amyloid Kidney (if known by pathology)
• Participants with any significant hepatic, cardiac, or pulmonary disease or participants who are clinically nephritic

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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31 participants in 4 patient groups

Inclisiran (normal renal function)

Experimental group

Description:

Participants will receive a single dose of 300 milligram (mg) inclisiran administered by SC injection on Day 1. Normal renal function is defined as estimated creatinine clearance (CrCl) of ≥90 milliliter (mL)/minute (min).

Treatment:

Drug: Inclisiran

Inclisiran (mild renal impairment)

Experimental group

Description:

Participants will receive a single dose of 300 mg inclisiran administered by SC injection on Day 1. Mild renal impairment is defined as CrCl ranging from 60 to 89 mL/min.

Treatment:

Drug: Inclisiran

Inclisiran (moderate renal impairment)

Experimental group

Description:

Participants will receive a single dose of 300 mg inclisiran administered by SC injection on Day 1. Moderate renal impairment is defined as CrCl ranging from 30 to 59 mL/min.

Treatment:

Drug: Inclisiran

Inclisiran (severe renal impairment)

Experimental group

Description:

Participants will receive a single dose of 300 mg inclisiran administered by SC injection on Day 1. Severe renal impairment is defined as CrCl ranging from 15 to 29 mL/min.

Treatment:

Drug: Inclisiran