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

Restless Legs Syndrome Clinical Trial

Official title:

An Open-Label, Parallel-Group, Repeat-Dose Study to Investigate the Effects of End Stage Renal Disease and Haemodialysis on the Pharmacokinetics of Ropinirole (Study RRL103628)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00422994
• Other study ID #: RRL103628
• Status: Completed
• Phase: Phase 1
• First received: January 12, 2007
• Last updated: October 24, 2016
• Start date: April 2006
• Est. completion date: December 2006

Study information

• Verified date: October 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Kidney Diseases
• Kidney Failure, Chronic
• Restless Legs Syndrome

Intervention

Drug:
• ropinirole dosing for up to 28 days

Locations

Country	Name	City	State
United Kingdom	GSK Investigational Site	London
United States	GSK Investigational Site	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SK&F-104557 and SK&F-89124 blood levels over 24 hours at Weeks 1 & 3 for all subjects.
Primary	SK&F-104557 and SK&F-89124 blood levels at beginning, middle, & end of hemodialysis period when "on dialysis" & "off dialysis" in patients.
Secondary	ECG: every other visit
Secondary	Vital Signs: Each visit
Secondary	Adverse Events: each visit
Secondary	Clinical laboratory: every other visit

External Links

•   Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.