A Multiple-Dose Study of Oral Oseltamivir in Participants on Hemodialysis (HD) and Continuous Ambulatory Peritoneal Dialysis (CAPD)

Roche

Status and phase: Completed; Phase 1

Conditions: End Stage Renal Disease

Treatments: Drug: Oseltamivir

Study type: Interventional

Funder types: Industry

Identifiers

NCT02617784

NP16472

Details and patient eligibility

About

This study is designed to assess the pharmacokinetics (PK) and safety of oseltamivir and its metabolite oseltamivir carboxylate in participants undergoing routine HD and CAPD for end-stage renal disease (ESRD). Participants will receive 6.5 and 6 weeks of the marketed oral oseltamivir suspension dosed according to the HD or CAPD schedule, respectively.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults greater than or equal to (>/=) 18 years of age
• ESRD defined as no residual renal function or a creatinine clearance (CrCl) less than (<) 10 milliliters per minute (mL/min)
• Well established HD or CAPD therapy over a period of 3 months with stable CrCl < 10 mL/min
• Body mass index (BMI) 18 to 34 kilograms per meter-squared (kg/m^2)
• Use of contraception among women of childbearing potential

Exclusion criteria

• Clinical significant comorbid disease or terminal illness
• Known human immunodeficiency virus (HIV) or hepatitis B or C
• History of drug or alcohol abuse within the prior year
• Donation or loss of >/= 400 milliliters (mL) of blood in the 3 months prior to Screening
• Participation in a clinical study with an investigational drug in the 3 months prior to study drug
• Pregnant or lactating women

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Regimen A: Oseltamivir with HD

Experimental group

Description:

Participants will receive 30 milligrams (mg) of oseltamivir via oral suspension approximately 1 hour after alternating HD sessions. Sessions will occur three times per week within the 6.5-week study period, and participants will receive a total of 9 doses of oseltamivir.

Treatment:

Drug: Oseltamivir

Regimen B: Oseltamivir with CAPD

Experimental group

Description:

Participants will receive 30 mg of oseltamivir via oral suspension once weekly after dialysis exchange. CAPD sessions will occur four times every 24 hours, and participants will receive a total of 6 doses of oseltamivir within the 6-week study period.

Treatment:

Drug: Oseltamivir