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

NCT00422994 | Completed Phase 1

• 1 other identifier: RRL103628
• Study Type: interventional
• Target: 48
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Conditions

Restless Legs Syndrome

Keywords

end stage renal impairment; tolerability; ropinirole; pharmacokinetics; hemodialysis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• ECG: every other visit

• Vital Signs: Each visit

• Adverse Events: each visit

• Clinical laboratory: every other visit

Interventions

ropinirole dosing for up to 28 days DRUG

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Female subjects who are pregnant and/or breast-feeding must not participate in this study.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (2)

GSK Investigational Site

Minneapolis, Minnesota, 55404, United States

Location

GSK Investigational Site

London, SW17 0QT, United Kingdom

Location

Related 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.

MeSH Terms

Conditions

Restless Legs Syndrome

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2007
• First Posted: January 17, 2007
• Study Start: April 1, 2006
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: October 26, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1); GB (1)