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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02617784




Registration number
NCT02617784
Ethics application status
Date submitted
27/11/2015
Date registered
1/12/2015
Date last updated
15/02/2016

Titles & IDs
Public title
A Multiple-Dose Study of Oral Oseltamivir in Participants on Hemodialysis (HD) and Continuous Ambulatory Peritoneal Dialysis (CAPD)
Scientific title
A Single Center, Open Label, Multiple-Dose Oral Oseltamivir Suspension Study in End-Stage-Renal Disease (ESRD) Patients on Hemodialysis (HD) and Continuous Ambulatory Peritoneal Dialysis (CAPD)
Secondary ID [1] 0 0
NP16472
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
End Stage Renal Disease 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Oseltamivir

Experimental: Regimen A: Oseltamivir with HD - 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.

Experimental: Regimen B: Oseltamivir with CAPD - 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: Drugs: Oseltamivir
Oseltamivir will be given as marketed oral suspension, 30 mg after HD or CAPD treatment.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Maximum Plasma Concentration (Cmax) of Oseltamivir in HD Participants During Days 1 to 5
Timepoint [1] 0 0
Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from Day 1 (D1) dose
Primary outcome [2] 0 0
Cmax of Oseltamivir in HD Participants During Days 38 to 43
Timepoint [2] 0 0
Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from Day 38 (D38) dose
Primary outcome [3] 0 0
Cmax of Metabolite Oseltamivir Carboxylate in HD Participants During Days 1 to 5
Timepoint [3] 0 0
Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D1 dose
Primary outcome [4] 0 0
Cmax of Metabolite Oseltamivir Carboxylate in HD Participants During Days 38 to 43
Timepoint [4] 0 0
Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D38 dose
Primary outcome [5] 0 0
Area Under the Concentration-Time Curve (AUC) of Oseltamivir in HD Participants During Days 1 to 5
Timepoint [5] 0 0
Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D1 dose
Primary outcome [6] 0 0
AUC of Oseltamivir in HD Participants During Days 38 to 43
Timepoint [6] 0 0
Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D38 dose
Primary outcome [7] 0 0
AUC of Metabolite Oseltamivir Carboxylate in HD Participants During Days 1 to 5
Timepoint [7] 0 0
Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D1 dose
Primary outcome [8] 0 0
AUC of Metabolite Oseltamivir Carboxylate in HD Participants During Days 38 to 43
Timepoint [8] 0 0
Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D38 dose
Primary outcome [9] 0 0
Cmax of Oseltamivir in CAPD Participants During Days 1 to 6
Timepoint [9] 0 0
Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 dose
Primary outcome [10] 0 0
Cmax of Oseltamivir in CAPD Participants During Days 36 to 43
Timepoint [10] 0 0
Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168 hours from Day 36 (D36) dose
Primary outcome [11] 0 0
Cmax of Metabolite Oseltamivir Carboxylate in CAPD Participants During Days 1 to 6
Timepoint [11] 0 0
Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 dose
Primary outcome [12] 0 0
Cmax of Metabolite Oseltamivir Carboxylate in CAPD Participants During Days 36 to 43
Timepoint [12] 0 0
Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168 hours from D36 dose
Primary outcome [13] 0 0
AUC of Oseltamivir in CAPD Participants During Days 1 to 6
Timepoint [13] 0 0
Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 dose
Primary outcome [14] 0 0
AUC of Oseltamivir in CAPD Participants During Days 36 to 43
Timepoint [14] 0 0
Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168 hours from D36 dose
Primary outcome [15] 0 0
AUC of Metabolite Oseltamivir Carboxylate in CAPD Participants During Days 1 to 6
Timepoint [15] 0 0
Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 dose
Primary outcome [16] 0 0
AUC of Metabolite Oseltamivir Carboxylate in CAPD Participants During Days 36 to 43
Timepoint [16] 0 0
Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168 hours from D36 dose
Secondary outcome [1] 0 0
Plasma Concentration of Oseltamivir by Timepoint in HD Participants
Timepoint [1] 0 0
Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49 hours from D1 and D38 dose AND at 90 hours from D1 dose AND at 114 hours from D38 dose
Secondary outcome [2] 0 0
Plasma Concentration of Metabolite Oseltamivir Carboxylate by Timepoint in HD Participants
Timepoint [2] 0 0
Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49 hours from D1 and D38 dose AND at 90 hours from D1 dose AND at 114 hours from D38 dose
Secondary outcome [3] 0 0
Time to Maximum Plasma Concentration (Tmax) of Oseltamivir in HD Participants
Timepoint [3] 0 0
Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D1 and D38 dose
Secondary outcome [4] 0 0
Tmax of Metabolite Oseltamivir Carboxylate in HD Participants
Timepoint [4] 0 0
Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D1 and D38 dose
Secondary outcome [5] 0 0
Oral Plasma Clearance (CL/F) of Oseltamivir in HD Participants
Timepoint [5] 0 0
Blood samples 0, 1, 2, 4, 8, 12 hours from D1 and D38 dose
Secondary outcome [6] 0 0
CL/F of Metabolite Oseltamivir Carboxylate in HD Participants
Timepoint [6] 0 0
Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42 hours from D1 and D38 dose
Secondary outcome [7] 0 0
Renal Clearance (CLr) of Oseltamivir in HD Participants
Timepoint [7] 0 0
Blood samples 0, 1, 2, 4, 8, 12 hours from D1 dose; urine samples 0 to 12 hours from D1 dose
Secondary outcome [8] 0 0
CLr of Metabolite Oseltamivir Carboxylate in HD Participants
Timepoint [8] 0 0
Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42 hours from D1 dose; urine samples 0 to 42 hours from D1 dose
Secondary outcome [9] 0 0
Dialysis Clearance (CLd) of Metabolite Oseltamivir Carboxylate in HD Participants
Timepoint [9] 0 0
Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from from D1 and D38 dose; dialyzer samples 1, 2, 4, 5 hours from start of dialysis on Days 3 and 40
Secondary outcome [10] 0 0
Percentage of Oseltamivir Dose Excreted as Unchanged Drug in HD Participants
Timepoint [10] 0 0
Urine samples 0 to 42 hours from D1 dose
Secondary outcome [11] 0 0
Percentage of Oseltamivir Dose Excreted as Metabolite Oseltamivir Carboxylate in HD Participants
Timepoint [11] 0 0
Urine samples 0 to 42 hours from D1 dose
Secondary outcome [12] 0 0
Plasma Concentration of Metabolite Oseltamivir Carboxylate in Arterial and Venous Blood by Timepoint in HD Participants
Timepoint [12] 0 0
Dialyzer samples 1, 2, 4, 5 hours from start of dialysis on Days 3 and 40
Secondary outcome [13] 0 0
Plasma Concentration of Oseltamivir by Timepoint in CAPD Participants
Timepoint [13] 0 0
Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 and D36 dose AND at 168 hours from D36 dose
Secondary outcome [14] 0 0
Plasma Concentration of Metabolite Oseltamivir Carboxylate by Timepoint in CAPD Participants
Timepoint [14] 0 0
Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 and D36 dose AND at 168 hours from D36 dose
Secondary outcome [15] 0 0
Tmax of Oseltamivir in CAPD Participants
Timepoint [15] 0 0
Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 and D36 dose AND at 168 hours from D36 dose
Secondary outcome [16] 0 0
Tmax of Metabolite Oseltamivir Carboxylate in CAPD Participants
Timepoint [16] 0 0
Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 and D36 dose AND at 168 hours from D36 dose
Secondary outcome [17] 0 0
Elimination Rate Constant of Metabolite Oseltamivir Carboxylate in CAPD Participants
Timepoint [17] 0 0
Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 and D36 dose AND at 168 hours from D36 dose; urine samples 0 to 48 hours from D1 dose; dialysate samples 0 to 48 hours from D1 dose
Secondary outcome [18] 0 0
Terminal Elimination Half-Life of Metabolite Oseltamivir Carboxylate in CAPD Participants
Timepoint [18] 0 0
Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 and D36 dose AND at 168 hours from D36 dose; urine samples 0 to 48 hours from D1 dose; dialysate samples 0 to 48 hours from D1 dose
Secondary outcome [19] 0 0
CL/F of Oseltamivir in CAPD Participants
Timepoint [19] 0 0
Blood samples 0, 1, 2, 4, 8, 12 hours from D1 and D36 dose
Secondary outcome [20] 0 0
CL/F of Metabolite Oseltamivir Carboxylate in CAPD Participants
Timepoint [20] 0 0
Blood samples 0, 1, 2, 4, 8, 12, 24, 48 hours from D1 and D36 dose
Secondary outcome [21] 0 0
CLr of Oseltamivir in CAPD Participants
Timepoint [21] 0 0
Blood samples 0, 1, 2, 4, 8, 12 hours from D1 dose; urine samples 0 to 12 hours from D1 dose
Secondary outcome [22] 0 0
CLr of Metabolite Oseltamivir Carboxylate in CAPD Participants
Timepoint [22] 0 0
Blood samples 0, 1, 2, 4, 8, 12, 24, 48 hours from D1 dose; urine samples 0 to 48 hours from D1 dose
Secondary outcome [23] 0 0
CLd of Metabolite Oseltamivir Carboxylate in CAPD Participants
Timepoint [23] 0 0
Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 dose; dialysate samples 0 to 48 hours from D1 dose
Secondary outcome [24] 0 0
Percentage of Oseltamivir Dose Renally Excreted as Unchanged Drug in CAPD Participants
Timepoint [24] 0 0
Urine samples 0 to 48 hours from D1 dose
Secondary outcome [25] 0 0
Percentage of Oseltamivir Dose Renally Excreted as Metabolite Oseltamivir Carboxylate in CAPD Participants
Timepoint [25] 0 0
Urine samples 0 to 48 hours from D1 dose
Secondary outcome [26] 0 0
Percentage of Oseltamivir Dose Eliminated by Dialysis as Unchanged Drug in CAPD Participants
Timepoint [26] 0 0
Dialysate samples 0 to 48 hours from D1 dose
Secondary outcome [27] 0 0
Percentage of Oseltamivir Dose Eliminated by Dialysis as Metabolite Oseltamivir Carboxylate in CAPD Participants
Timepoint [27] 0 0
Dialysate samples 0 to 48 hours from D1 dose

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2001
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2002
Sample size
Target
Accrual to date
Final
24
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/study/NCT02617784
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02617784