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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00422994
First received: January 12, 2007
Last updated: May 31, 2012
Last verified: February 2011
  Purpose

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


Condition Intervention Phase
Restless Legs Syndrome
End Stage Renal Disease
Drug: ropinirole dosing for up to 28 days
Phase 1

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:


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:
    Drug: ropinirole dosing for up to 28 days
    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 GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00422994     History of Changes
Other Study ID Numbers: RRL103628
Study First Received: January 12, 2007
Last Updated: May 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
end stage renal impairment
tolerability
ropinirole
pharmacokinetics
hemodialysis

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Restless Legs Syndrome
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Parasomnias
Mental Disorders
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 April 20, 2014