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

This study has been completed.

First Received on January 12, 2007. Last Updated on February 19, 2009 History of Changes

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic
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)

Resource links provided by NLM:

MedlinePlus related topics: Dialysis Kidney Failure

Drug Information available for: Ropinirole hydrochloride Ropinirole

U.S. FDA Resources

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:

ECG: every other visit
Vital Signs: Each visit
Adverse Events: each visit
Clinical laboratory: every other visit

Estimated Enrollment:	48
Study Start Date:	April 2006

Intervention Details:

Other Name: ropinirole dosing for up to 28 days

Eligibility

Ages Eligible for Study:	18 Years to 79 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

No publications provided

Responsible Party:	Study Director, GSK
ClinicalTrials.gov Identifier:	NCT00422994 History of Changes
Other Study ID Numbers:	RRL103628
Study First Received:	January 12, 2007
Last Updated:	February 19, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

ropinirole
hemodialysis
end stage renal impairment
pharmacokinetics
tolerability

Additional relevant MeSH terms:

Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Ropinirole
Antiparkinson Agents
Anti-Dyskinesia Agents

Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 12, 2012