A Study To Investigate The Effects Of End Stage Renal Disease And Hemodialysis On The Pharmacokinetics Of Ropinirole

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Restless Legs Syndrome

Treatments: Drug: ropinirole dosing for up to 28 days

Study type: Interventional

Funder types: Industry

Identifiers

NCT00422994

RRL103628

Details and patient eligibility

About

This study will investigate the effects of severe renal impairment and hemodialysis on the characteristics of the drug, ropinirole.

Enrollment: 48 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)