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

This study has been completed.

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00422994

Purpose

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

Condition	Intervention	Phase
End Stage Renal Disease	Drug: ropinirole dosing for up to 28 days	Phase I

MedlinePlus related topics: Dialysis Kidney Failure

Drug Information available for: Ropinirole Ropinirole hydrochloride

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Parallel Assignment, Pharmacokinetics Study
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)

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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 Outcome Measures:

Estimated Enrollment:	48
Study Start Date:	April 2006

Eligibility

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00422994

Locations

United States, Minnesota
GSK Investigational Site
Minneapolis, Minnesota, United States, 55404
United Kingdom
GSK Investigational Site
London, United Kingdom, SW17 0QT

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MBChB, MFPM

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	RRL103628
Study First Received:	January 12, 2007
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00422994
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

ropinirole
hemodialysis
end stage renal impairment
pharmacokinetics
tolerability

Study placed in the following topic categories:

Ropinirole
Renal Insufficiency
Dopamine
Urologic Diseases

Renal Insufficiency, Chronic
Kidney Failure, Chronic
Kidney Diseases
Kidney Failure

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Therapeutic Uses
Physiological Effects of Drugs

Antiparkinson Agents
Dopamine Agents
Dopamine Agonists
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009