Restless Legs Syndrome
Conditions
Keywords
end stage renal impairment, tolerability, ropinirole, pharmacokinetics, hemodialysis
Brief summary
This study will investigate the effects of severe renal impairment and hemodialysis on the characteristics of the drug, ropinirole.
Interventions
DRUGropinirole dosing for up to 28 days
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
Yes
Inclusion criteria
Inclusion: * Patients and subjects between 18-79 years old. * End stage renal patients who are consistently receiving dialysis for a minimum of 3.5 hours, three times per week, with hemodialysis blood flow rates of \>200mL/min may be eligible to enter the study. * Patients must also have systolic blood pressure 100-190mmHg and diastolic blood pressure \<120mmHg. * Healthy subjects must have systolic blood pressure 100-150mmHg. Exclusion: * Female subjects who are pregnant and/or breast-feeding must not participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SK&F-104557 and SK&F-89124 blood levels over 24 hours at Weeks 1 & 3 for all subjects. | — |
| SK&F-104557 and SK&F-89124 blood levels at beginning, middle, & end of hemodialysis period when on dialysis & off dialysis in patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| ECG: every other visit | — |
| Vital Signs: Each visit | — |
| Adverse Events: each visit | — |
| Clinical laboratory: every other visit | — |
Countries
United Kingdom, United States
Outcome results
None listed