NCT02452437

Brief Summary

To measure oxycodone's intradialytic mass transfer rate coefficient and oxycodone's removal rate using an ODE/PDE hemodialysis model. To implement a rational clinical strategy for estimating a patient's post-hemodialysis oxycodone restoration dose using results from an ODE/PDE model of hemodialysis.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started May 2015

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

May 20, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

May 22, 2015

Status Verified

May 1, 2015

Enrollment Period

4 months

First QC Date

May 20, 2015

Last Update Submit

May 21, 2015

Conditions

Chronic Kidney Disease

Keywords

oxycodonehemodialysis

Outcome Measures

Primary Outcomes (1)

  • Oxycodone's intradialytic mass transfer coefficient

    t=0 to t=4 hours

Study Arms (2)

control

EXPERIMENTAL

Oxycodone will be administered and subjects will undergo hemodialysis

Drug: Oxycodone

hemodialysis

EXPERIMENTAL

Oxycodone will be administered and subjects will undergo hemodialysis

Drug: Oxycodone

Interventions

OxycodoneDRUG

Controlled release oxycodone 40 mg twice daily

Also known as: OxyContin
controlhemodialysis

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy, non-smoking, opioid intolerant Caucasian men and women controls.
  • Hemodialysis patients age 44 ± 10 (mean ± SD) years and normal controls 36 ± 9 years.
  • No statistically significant difference in weight between hemodialysis and control patients.
  • Mean serum creatinine concentrations of 7.29 ± 1.48 mg/dL in hemodialysis patients and 0.81 ± 0.12 mg/dL in controls (normal 0.7 to 1.3 mg/dL for men and 0.6 to 1.1 mg/dL for women)
  • Mean urine output of 1.83 ± 0.47 mL/hr (44 ± 11 mL/24 hr) in hemodialysis patients and 62.32 ± 16.01 mL/hr (1496 ± 384 mL/24 hr) in controls.
  • Patients in both groups with normal liver function. Serum prothrombin time (PT/INR), aPTT, albumin, bilirubin (direct and indirect), liver transaminases, gamma-glutamyl transferase and alkaline phosphatase normal.

You may not qualify if:

  • In both groups, a clinically significant electrocardiogram (ECG) abnormality.
  • An uncontrolled clinically significant cardiovascular condition other than end-stage kidney disease.
  • Elevated transaminases, alkaline phosphatase, bilirubin, low phosphodiesterase, elevated ammonia levels, low glucose, elevated lactate, elevated creatinine, and hypoxia (hepatorenal syndrome)
  • Serum positive for HIV, hepatitis BsAg, or Hepatitis C
  • A history of drug or alcohol abuse within the past 24 months
  • Currently participating (or participated within the previous 30 days in an investigational therapeutic or device study
  • Female who is pregnant, nursing, or of child-bearing potential not practicing effective contraceptive methods.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oscar A. Linares, MD

Dearborn, Michigan, 48124, United States

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Oxycodone

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CodeineMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Oscar A Linares, MD

    Emerio & Lourdes Linares Research and Education Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Oscar A Linares, MD

CONTACT

734-735-4022oalinaresmd@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2015

First Posted

May 22, 2015

Study Start

May 1, 2015

Primary Completion

September 1, 2015

Study Completion

December 1, 2015

Last Updated

May 22, 2015

Record last verified: 2015-05

Locations

US(1)