A Study to Investigate the Effect of Renal Function and Hemodialysis on the Pharmacokinetics (PK) of RO7079901

Completed · Phase 1

Conditions studied: Renal Impairment

In brief

This is a multi-center, non-randomized, open-label, two-part study to investigate the effect of renal function and hemodialysis on PK of RO7079901. Part 1 will be conducted in adult male and female participants with stable mild, moderate or severe renal impairment and a control group of participants with normal renal function. Part 2 will be conducted in adult male and female participants with stable end-stage renal disease undergoing hemodialysis.

Key facts

Study ID

NCT02975388

Run by

Hoffmann-La Roche

People needed

29

Starts

2016-12-20

Expected to finish

2017-07-06

Last updated by the study team

2017-12-11

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Body Mass Index (BMI) between 18 and 38 kilograms per square-meter (kg/m\^2) and body weight of at least 45 kilograms (kg)
• Control group participants, Part 1 only:
• Normal renal function based on creatinine clearance greater than or equal to (>=) 90 milliliters per minute (mL/min) at the Screening visit
• Healthy for age-group, as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG)
• Participants with renal impairment, Part 1 only:
• Reduced renal function based on estimated creatinine clearance at the Screening visit. Creatinine clearance can be estimated from serum creatinine concentration at the Screening visit using the Cockcroft-Gault equation, or be a historical measured value obtained within the preceding 3 months. Participants with severe, moderate or mild renal impairment must have creatinine clearance of less than or equal to (<=) 29, 30 to 59, or 60 to 89 mL/min, respectively
• Stable renal function. The stability of renal function will be confirmed by two determinations of serum creatinine separated by at least 7 days (one of which can be a historical value within the last 3 months). Renal function will be considered stable if the 2 serum creatinine values differ by <=30 percent (%) of the lower value
• Participants with end-stage renal disease in Part 2 only:
• Reduced renal function with a clinical diagnosis of end-stage renal disease requiring renal replacement therapy
• Receiving hemodialysis for more than 3 months at the time of the Screening visit

You may not qualify if…

• Recipient of a renal transplant (Part 1 only)
• Presence of renal carcinoma, or acute renal disease caused by infection or drug toxicity
• Nephrotic syndrome (defined as plasma albumin less than [<] 3 grams per deciliter [g/dL] and/or proteinuria greater than [>] 3 grams per day [g/day])
• Hemoglobin concentration <10 g/dL, or <9 g/dL for participants with end-stage renal disease
• Potassium concentration >5.5 millimoles per liter (mmol/L)
• Clinically significant liver disease
• Uncontrolled blood pressure
• Any condition associated with intra-vascular volume depletion
• Any unstable clinically significant disease
• Any other ongoing condition or disease (apart from renal dysfunction), or clinically significant abnormalities in laboratory test results that the investigator considers would render the participant unsuitable for the study, place the participant at undue risk or interfere with the ability of the participant to complete the study
• Major surgery or significant traumatic injury <28 days prior to the first administration (excluding biopsies), or anticipation of the need for major surgery during study treatment
• Recent history of alcoholism, drug abuse, or addiction within the last year prior to screening
• Positive test at Screening of any of the following: Hepatitis A, Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV)
• Clinically significant change in disease status as judged by the investigator, or any major illness within the 4 weeks prior to the Screening visit, or febrile illness within 14 days prior to the Screening visit
• Use of prohibited medications, or alteration to a concomitant medication treatment regimen considered relevant by the investigator within 14 days before the Screening visit
• Known history of clinically significant hypersensitivity or severe allergic reaction to any drug, in particular antibiotics (e.g., cephalosporins, penicillins, carbapenems, or monobactams)
• Participation in another clinical study with an investigational drug or device within the 1 month preceding the Screening vist
• Donation or loss of over 500 milliliters (mL) of blood within the 3 months before the Screening visit

Where it is running

• Clinical Pharmacology of Miami, Inc. — Miami, Florida, United States
• Orlando Clinical Research Center — Orlando, Florida, United States
• DaVita Clinical Research — Minneapolis, Minnesota, United States
• Prism Clinical Research — Saint Paul, Minnesota, United States
• New Orleans Center for Clinical Research — Knoxville, Tennessee, United States

Full record on ClinicalTrials.gov

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