Recruiting

Opioids

Sponsor:

Emerio & Lourdes Linares Research and Education Center

Code:

NCT02452437

Conditions

Chronic Kidney Disease

Eligibility Criteria

Sex: All

Age: 30 - 60

Healthy Volunteers: Accepted

Interventions

Oxycodone

Study Details

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.

Conditions

Chronic Kidney Disease

Study ID

NCT02452437

Start date

May, 2015

Status verified date

May, 2015

Completion date

Dec, 2015

Anticipated

Primary completion date

Sep, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 60

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

20 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: control

Oxycodone will be administered and subjects will undergo hemodialysis

experimental: hemodialysis

Oxycodone will be administered and subjects will undergo hemodialysis

Interventions

Oxycodone

Controlled release oxycodone 40 mg twice daily

Primary outcome measure

  • Oxycodone's intradialytic mass transfer coefficient [ Time Frame: t=0 to t=4 hours ]

Central Contacts and Locations

Central contacts

Oscar A Linares, MD

734-735-4022oalinaresmd@gmail.com

Locations

Oscar A. Linares, MD

Recruiting

Dearborn, Michigan, United States, 48124

Contacts

Oscar A Linares, MD

734-735-4022oalinaresmd@gmail.com

More Information

Sponsor

Emerio & Lourdes Linares Research and Education Center

Last update posted

May 22, 2015

Last verified

May, 2015

Keywords

  • oxycodone
  • hemodialysis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Emerio & Lourdes Linares Research and Education Center on 2015-05-22.